@Article{info:doi/10.2196/64028,
author="Schmieding, L. Malte
and Kopka, Marvin
and Bolanaki, Myrto
and Napierala, Hendrik
and Altendorf, B. Maria
and Kuschick, Doreen
and Piper, K. Sophie
and Scatturin, Lennart
and Schmidt, Konrad
and Schorr, Claudia
and Thissen, Alica
and W{\"a}scher, Cornelia
and Heintze, Christoph
and M{\"o}ckel, Martin
and Balzer, Felix
and Slagman, Anna",
title="Impact of a Symptom Checker App on Patient-Physician Interaction Among Self-Referred Walk-In Patients in the Emergency Department: Multicenter, Parallel-Group, Randomized, Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Apr",
day="2",
volume="27",
pages="e64028",
keywords="digital health",
keywords="triage",
keywords="symptom checker",
keywords="patient-centered care",
keywords="eHealth apps",
keywords="mobile phone",
keywords="decision support systems",
keywords="consumer health information",
keywords="health literacy",
keywords="randomized controlled trials",
keywords="null results",
keywords="emergency care",
keywords="patient-physician-interaction",
keywords="patient satisfaction",
abstract="Background: Symptom checker apps (SCAs) are layperson-facing tools that advise on whether and where to seek care, or possible diagnoses. Previous research has primarily focused on evaluating the accuracy, safety, and usability of their recommendations. However, studies examining SCAs' impact on clinical care, including the patient-physician interaction and satisfaction with care, remain scarce. Objective: This study aims to evaluate the effects of an SCA on satisfaction with the patient-physician interaction in acute care settings. Additionally, we examined its influence on patients' anxiety and trust in the treating physician. Methods: This parallel-group, randomized controlled trial was conducted at 2 emergency departments of an academic medical center and an emergency practice in Berlin, Germany. Low-acuity patients seeking care at these sites were randomly assigned to either self-assess their health complaints using a widely available commercial SCA (Ada Health) before their first encounter with the treating physician or receive usual care. The primary endpoint was patients' satisfaction with the patient-physician interaction, measured by the Patient Satisfaction Questionnaire (PSQ). The secondary outcomes were patients' satisfaction with care, their anxiety levels, and physicians' satisfaction with the patient-physician interaction. We used linear mixed models to assess the statistical significance of primary and secondary outcomes. Exploratory descriptive analyses examined patients' and physicians' perceptions of the SCA's utility and the frequency of patients questioning their physician's authority. Results: Between April 11, 2022, and January 25, 2023, we approached 665 patients. A total of 363 patients were included in the intention-to-treat analysis of the primary outcome (intervention: n=173, control: n=190). PSQ scores in the intervention group were similar to those in the control group (mean 78.5, SD 20.0 vs mean 80.8, SD 19.6; estimated difference --2.4, 95\% CI --6.3 to 1.1, P=.24). Secondary outcomes, including patients' and physicians' satisfaction with care and patient anxiety, showed no significant group differences (all P>.05). Patients in the intervention group were more likely to report that the SCA had a beneficial (66/164, 40.2\%) rather than a detrimental (3/164, 1.8\%) impact on the patient-physician interaction, with most reporting no effect (95/164, 57.9\%). Similar patterns were observed regarding the SCA's perceived effect on care. In both groups, physicians rarely reported that their authority had been questioned by a patient (intervention: 2/188, 1.1\%; control: 4/184, 2.2\%). While physicians more often found the SCA helpful rather than unhelpful, the majority indicated it was neither helpful nor unhelpful for the encounter. Conclusions: We found no evidence that the SCA improved satisfaction with the patient-physician interaction or care in an acute care setting. By contrast, both patients and their treating physicians predominantly described the SCA's impact as beneficial. Our study did not identify negative effects of SCA use commonly reported in the literature, such as increased anxiety or diminished trust in health care professionals. Trial Registration: German Clinical Trial Register DRKS00028598; https://drks.de/search/en/trial/DRKS00028598/entails International Registered Report Identifier (IRRID): RR2-10.1186/s13063-022-06688-w ",
doi="10.2196/64028",
url="https://www.jmir.org/2025/1/e64028"
}


@Article{info:doi/10.2196/72002,
author="Evans, Douglas William
and Ichimiya, Megumi
and Bingenheimer, B. Jeffrey
and Cantrell, Jennifer
and D'Esterre, P. Alexander
and Pincus, Olivia
and Yu, Q. Linda
and Hair, C. Elizabeth",
title="Design and Baseline Evaluation of Social Media Vaping Prevention Trial: Randomized Controlled Trial Study",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="31",
volume="27",
pages="e72002",
keywords="social media",
keywords="e-cigarettes",
keywords="randomized controlled trial",
keywords="nicotine",
keywords="oral nicotine products",
keywords="nicotine poly-use",
abstract="Background: Electronic cigarette (e-cigarette) use is a major public health problem and young adults aged 18-24 years are at high risk. Furthermore, oral nicotine products (ONPs) are growing in popularity in this population. Poly-use is widespread. New methodologies for rigorous online studies using social media have been conducted and shown to reduce nicotine use. Objective: We report on the design and baseline evaluation of a large-scale social media--based randomized controlled trial to evaluate the effects of antivaping social media on young adult vaping and determinants of use. Methods: Using the Virtual Lab social media platform, participants were recruited using an artificial intelligence chatbot and social media advertising, completed a baseline survey, and were randomized to 1 of 4 study arms. The design was to achieve specific numbers of impressions per arm over 3 survey time points. We recruited 8437 participants, stratified by vaper (n=5026) and nonvaper (n=3321) status. Questionnaire data were collected using the Qualtrics survey platform. Future analyses will examine the effects of social media content on vaping at the endline. Our data analysis describes the 2 cohort samples, examines balance across the 4 study arms on baseline variables in each of the cohorts, and evaluates the internal consistency of several multi-indicator measures of psychosocial constructs. Results: Among vapers, almost three-fourths were current vapers, >40\% were current smokers (using in the past 30 days), and >48\% were current poly-users (using e-cigarettes and ?1 other tobacco products). Substantial numbers of current vapers also currently use some other product, including cigars (n=1520, 30.2\%), hookah (n=794, 15.8\%), smokeless devices (n=462, 9.2\%), and ONPs (n=578, 11.5\%). The average age of participants was 21.2 (SD 2) years. Just less than 45\% of participants were non-Hispanic White (n=3728, 44.7\%), just less than 47\% (n=3913, 46.9\%) of the sample was male, more than 44\% (n=3704, 44.4\%) reported completing high school, and 79.3\% reported meeting basic needs or better. There were no significant differences between arms and strata by any of these demographics. We calculated scale scores for depression and covariates related to nicotine use and found high alphas. Finally, participants who reported having seen antitobacco brand advertising were more likely to have higher levels of these variables and scales than participants who reported not having seen the advertisements. These results will be examined in future studies. Conclusions: Social media can be used as a platform at scale for longitudinal randomized controlled trials over extended periods, which extends previous research on short-term trials. Interventions delivered by social media can be used with large samples to evaluate social media health behavior change interventions. Future studies based on this research will evaluate the intervention and dose-response effects of social media exposure on vaping behavior and determinants. Trial Registration: ClinicalTrials.gov NCT04867668; https://clinicaltrials.gov/study/NCT04867668 ",
doi="10.2196/72002",
url="https://www.jmir.org/2025/1/e72002"
}


@Article{info:doi/10.2196/67539,
author="Pettersson, Beatrice
and Lundin-Olsson, Lillemor
and Skelton, A. Dawn
and Liv, Per
and Zingmark, Magnus
and Rosendahl, Erik
and Sandlund, Marlene",
title="Effectiveness of the Safe Step Digital Exercise Program to Prevent Falls in Older Community-Dwelling Adults: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="31",
volume="27",
pages="e67539",
keywords="geriatric medicine",
keywords="aging",
keywords="accidental falls",
keywords="independent living",
keywords="exercise therapy",
keywords="fall prevention",
keywords="electronic health",
keywords="mobile health",
keywords="preventive medicine",
keywords="self-management",
keywords="effectiveness",
keywords="randomized controlled trial",
keywords="older adults",
keywords="digital technology",
abstract="Background: Falls among older adults are a significant public health issue due to their high incidence, severe consequences, and substantial economic impact. Exercise programs incorporating balance and functional exercises have been shown to reduce fall rates, but adherence and scaling up the interventions remain challenges. Digital technology offers a promising avenue to deliver this type of exercise, potentially improving exercise adherence and enabling self-management of exercise in the aging population. Objective: This study aims to assess the effectiveness of the Safe Step app, a self-managed, unsupervised, home-based digital exercise program, in reducing fall rates or fall risk in community-dwelling older adults. Additional aims were to describe fall-related injuries in both the exercise and control groups, study attrition, and adherence to the Safe Step exercise program. Methods: Community-dwelling individuals, aged 70 years or older, who had experienced falls or a decline in balance in the past year were randomized to either an exercise group using the Safe Step app combined with educational videos, or a control group receiving educational videos alone. Both interventions lasted for 1 year. Information regarding fall events was self-reported monthly through questionnaires. Exercise adherence was monitored through questionnaires every third month. Negative binomial and logistic regression estimated the incidence rate ratio of fall rate and the risk ratio (RR) of experiencing falls, respectively. Fall-related injuries, study attrition, and exercise adherence were reported descriptively. Results: In total, 1628 people were enrolled in the study, 79\% were women, and the mean age was 75.8 (SD 4.4) years (range 70-94 years). The intention-to-treat analysis showed no significant difference in fall rates between the exercise and control groups after 12 months (2.21 falls per person-year in the exercise group and 2.41 in the control group; incidence rate ratio 0.92, 95\% CI 0.76-1.11; P=.37). The risk of experiencing at least 1 fall was significantly lower (11\%) in the exercise group compared to the control group (53\% vs 59.6\%; RR 0.89, 95\% CI 0.80-0.99; P=.03). No differences were observed regarding the risk of 2 or more falls (34.1\% in the exercise group, 37.1\% in the control group; RR 0.92, 95\% CI 0.79-1.06; P=.23). Injurious fall rates were similar between the exercise and control group. During the trial, 161 (20\%) participants from the exercise group and 63 (8\%) from the control group formally withdrew. The proportion of exercise group participants meeting the 90-minute weekly exercise goal was 12.7\%, 13.4\%, 8.6\%, and 9.1\% at 3, 6, 9, and 12 months, respectively. Conclusions: Access to a self-managed unsupervised digital exercise program can be an effective component of a primary fall prevention strategy for community-dwelling older adults. Further research is needed to explore the mediating factors that influence the outcomes and develop strategies that enhance adherence for optimal impact in this population. Trial Registration: ClinicalTrials.gov NCT03963570; https://clinicaltrials.gov/study/NCT03963570 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-036194 ",
doi="10.2196/67539",
url="https://www.jmir.org/2025/1/e67539"
}


@Article{info:doi/10.2196/57537,
author="Tandon, Puneeta
and Ismond, P. Kathleen
and Purdy, Graeme
and Cruz, Christofer
and Etruw, Evelyn
and Suderman, Kirsten
and Hyde, Ashley
and Stickland, Michael
and Spence, C. John
and Lien, C. Dale
and Bhanji, Rahima
and Prado, M. Carla
and Miguel-Cruz, Antonio
and Joy, A. Anil
and Yaskina, Maryna
and McNeely, L. Margaret",
title="Acceptability and Effectiveness of a Fully Web-Based Nutrition and Exercise Program for Individuals With Chronic Disease During COVID-19: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="24",
volume="27",
pages="e57537",
keywords="eHealth",
keywords="patient-centered care",
keywords="adults",
keywords="geriatrics",
keywords="self-management",
keywords="web-based",
keywords="nutrition",
keywords="exercise rehabilitation",
keywords="wearable",
keywords="activity tracker",
keywords="quality of life",
keywords="physical health",
keywords="2-minute step test",
keywords="patients with cancer",
keywords="chronic diseases",
keywords="COVID-19",
keywords="randomized controlled trial",
keywords="acceptability",
keywords="effectiveness",
keywords="intervention",
abstract="Background: In-person nutrition and exercise interventions improve physical function in chronic diseases, yet the acceptability and effectiveness of web-based delivery, especially with different levels of personnel support, require further investigation. Objective: This study aims to evaluate a web-based nutrition and exercise intervention delivered entirely digitally from recruitment to trial completion. Methods: A randomized controlled trial was conducted using the Heal-Me version 1 platform across 2 levels of personnel support (Light and Intensive). Eligible adults with a history of cancer, chronic lung disease, or liver or lung transplant; internet access; and prior participation in a rehabilitation program were enrolled in a fully web-based program to minimize barriers to exercise participation. Participants were randomly assigned (1:1:1) to 1 of 3 study groups. The control group received a detailed, self-directed digital nutrition and exercise guide. The Heal-Me Light group received the web-based intervention alongside dietitian and exercise specialist--led group classes. The Heal-Me Intensive group received web-based intervention, group classes, and one-to-one sessions with the dietitians and exercise specialists. All participants received a wearable activity tracker. The primary acceptability outcome was adherence to the intervention based on a priori targets. The primary effectiveness outcome was the change in Lower Extremity Functional Scale (LEFS) score. Secondary outcomes included physical function tests, which were performed and measured by videoconference. Questionnaires were used to assess well-being, quality of life, and food intake. Analyses adhered to the intention-to-treat principle. Results: Of 216 participants, 202 (93.5\%) completed the intervention (mean 61, SD 11 years; female: 130/202, 64.4\%; cancer: 126/202, 62.4\%). Adherence exceeded a priori targets, with 82\% (105/128) attending >75\% of the program elements including postintervention tests. Participants rated the program as ``quite a bit'' or ``very'' useful, with similar ratings between Heal-Me Light (56/64, 88\%) and Heal-Me Intensive (51/58, 88\%) groups (P=.69). No significant differences were found for changes in LEFS scores (control: mean 0.8, SD 7.7; Heal-Me: mean 0.3, SD 6.6; P=.53). Significant benefits were found in favor of the combined Heal-Me intervention groups versus controls for change in the 2-minute step test, World Health Organization-5 Well-Being Index, Short-Form-36 general, physical health role, energy or fatigue scales, and protein intake. While the change in physical function was similar between the 2 intervention arms, the more intensive one-to-one interaction (Heal-Me Intensive) led to greater improvements in perceived nutrition self-management. No serious adverse events occurred. Conclusions: The demonstrated satisfaction, adherence, and effectiveness highlight the high acceptability of a web-based, semisupervised nutrition and exercise intervention delivered entirely digitally in individuals with chronic disease. Future studies may benefit from having a baseline physical function inclusion threshold, the use of a more sensitive primary physical function measure, and a higher intensity digital exercise intervention in exercise-experienced participants. Trial Registration: Clinicaltrials.gov NCT04666558; https://clinicaltrials.gov/study/NCT04666558 International Registered Report Identifier (IRRID): RR2-10.1016/j.cct.2022.106791 ",
doi="10.2196/57537",
url="https://www.jmir.org/2025/1/e57537",
url="http://www.ncbi.nlm.nih.gov/pubmed/40126542"
}


@Article{info:doi/10.2196/73258,
author="Mansoor, Masab
and Ibrahim, F. Andrew
and Grindem, David
and Baig, Asad",
title="Authors' Response to Peer Reviews of ``Large Language Models for Pediatric Differential Diagnoses in Rural Health Care: Multicenter Retrospective Cohort Study Comparing GPT-3 With Pediatrician Performance''",
journal="JMIRx Med",
year="2025",
month="Mar",
day="19",
volume="6",
pages="e73258",
keywords="natural language processing",
keywords="NLP",
keywords="machine learning",
keywords="ML",
keywords="artificial intelligence",
keywords="language model",
keywords="large language model",
keywords="LLM",
keywords="generative pretrained transformer",
keywords="GPT",
keywords="pediatrics",
doi="10.2196/73258",
url="https://xmed.jmir.org/2025/1/e73258"
}


@Article{info:doi/10.2196/62828,
author="Holst, Christine
and Woloshin, Steven
and Oxman, D. Andrew
and Rose, Christopher
and Rosenbaum, Sarah
and Munthe-Kaas, Menzies Heather",
title="Alternative Presentations of Overall and Statistical Uncertainty for Adults' Understanding of the Results of a Randomized Trial of a Public Health Intervention: Parallel Web-Based Randomized Trials",
journal="JMIR Public Health Surveill",
year="2025",
month="Mar",
day="18",
volume="11",
pages="e62828",
keywords="communication",
keywords="Grading of Recommendations Assessment, Development, and Evaluation language",
keywords="GRADE language",
keywords="statistical uncertainty",
keywords="overall uncertainty",
keywords="randomized trial",
abstract="Background: Well-designed public health messages can help people make informed choices, while poorly designed messages or persuasive messages can confuse, lead to poorly informed decisions, and diminish trust in health authorities and research. Communicating uncertainties to the public about the results of health research is challenging, necessitating research on effective ways to disseminate this important aspect of randomized trials. Objective: This study aimed to evaluate people's understanding of overall and statistical uncertainty when presented with alternative ways of expressing randomized trial results. Methods: Two parallel, web-based, individually randomized trials (3{\texttimes}2 factorial designs) were conducted in the United States and Norway. Participants were randomized to 1 of 6 versions of a text (summary) communicating results from a study examining the effects of wearing glasses to prevent COVID-19 infection. The summaries varied in how overall uncertainty (``Grading of Recommendations Assessment, Development and Evaluation [GRADE] language,'' ``plain language,'' or ``no explicit language'') and statistical uncertainty (whether a margin of error was shown or not) were presented. Participants completed a web-based questionnaire exploring 4 coprimary outcomes: 3 to measure understanding of overall uncertainty (benefits, harms, and sufficiency of evidence), and one to measure statistical uncertainty. Participants were adults who do not wear glasses recruited from web-based research panels in the United States and Norway. Results of the trials were analyzed separately and combined in a meta-analysis. Results: In the US and Norwegian trials, 730 and 497 individuals were randomized, respectively; data for 543 (74.4\%) and 452 (90.9\%) were analyzed. More participants had a correct understanding of uncertainty when presented with plain language (United States: 37/99, 37\% and Norway: 40/76, 53\%) than no explicit language (United States: 18/86, 21\% and Norway: 34/80, 42\%). Similar positive effect was seen for the GRADE language in the United States (26/79, 33\%) but not in Norway (30/71, 42\%). There were only small differences between groups for understanding the uncertainty of harms. Plain language improved correct understanding of evidence sufficiency (odds ratio 2.05, 95\% CI 1.17-3.57), compared to no explicit language. The effect of GRADE language was inconclusive (odds ratio 1.34, 95\% CI 0.79-2.28). The understanding of statistical uncertainty was improved when the participants were shown the margin of error compared to not being shown: Norway: 16/75, 21\% to 24/71, 34\% vs 1/71, 1\% to 2/76, 3\% and the United States: 21/101, 21\% to 32/90, 36\% vs 0/86, 0\% to 3/79, 4\%). Conclusions: Plain language, but not GRADE language, was better than no explicit language in helping people understand overall uncertainty of benefits and harms. Reporting margin of error improved understanding of statistical uncertainty around the effect of wearing glasses, but only for a minority of participants. Trial Registration: ClinicalTrials.gov NCT05642754; https://tinyurl.com/4mhjsm7s ",
doi="10.2196/62828",
url="https://publichealth.jmir.org/2025/1/e62828"
}


@Article{info:doi/10.2196/60102,
author="Janowski, Roselinde
and Cluver, D. Lucie
and Shenderovich, Yulia
and Wamoyi, Joyce
and Wambura, Mwita
and Stern, David
and Clements, Lily
and Melendez-Torres, J. G.
and Baerecke, Lauren
and Ornellas, Abigail
and Chetty, Nicole Angelique
and Klapwijk, Jonathan
and Christine, Laetitia
and Mukabana, Ateamate
and Te Winkel, Esmee
and Booij, Anna
and Mbosoli, Gervas
and Lachman, M. Jamie",
title="Optimizing Engagement With a Smartphone App to Prevent Violence Against Adolescents: Results From a Cluster Randomized Factorial Trial in Tanzania",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="10",
volume="27",
pages="e60102",
keywords="digital health",
keywords="engagement",
keywords="parenting",
keywords="adolescents",
keywords="low- and middle-income country",
keywords="violence against children",
keywords="Multiphase Optimization Strategy",
keywords="randomized factorial experiment",
keywords="mobile phone",
abstract="Background: Violence and abuse exert extensive health, social, and economic burdens on adolescents in low- and middle-income countries. Digital parenting interventions are promising for mitigating risks at scale. However, their potential for public health impact hinges on meaningful engagement with the digital platform. Objective: The objective of this study was to evaluate the impact of 3 intervention design and implementation factors aimed at increasing engagement with a noncommercialized, offline-first smartphone app for caregivers of adolescents in Tanzania, in partnership with the United Nations Children's Fund, the World Health Organization, and the Tanzanian national government. Methods: Following Multiphase Optimization Strategy (MOST) principles, we conducted a 2{\texttimes}2{\texttimes}2 cluster randomized factorial trial involving caregivers of adolescents aged 10 to 17 years. Caregivers were recruited by community representatives from 16 urban and periurban communities (ie, clusters) in the Mwanza region of Tanzania. Each cluster was randomized to 1 of 2 levels of each factor: guidance (self-guided or guided via facilitator-moderated WhatsApp groups), app design (structured or unstructured), and preprogram digital support (basic or enhanced). Primary outcomes were automatically tracked measures of engagement (app launches, modules completed, and home practice activities reviewed), with secondary outcomes including modules started, time spent in the app, and positive behaviors logged. Generalized linear mixed-effects models assessed the impact of experimental factors on engagement. Results: Automatically tracked engagement data from 614 caregivers were analyzed, of which 205 (33.4\%) were men. Compared to self-guided participants, receiving guidance alongside the app led to significantly more app launches (mean ratio [MR] 2.93, 95\% CI 1.84-4.68; P<.001), modules completed (MR 1.29, 95\% CI 1.05-1.58; P=.02), modules started (MR 1.20, 95\% CI 1.02-1.42; P=.03), time spent in the app (MR 1.45, 95\% CI 1.39-1.51; P<.001), and positive behavior logs (MR 2.73, 95\% CI 2.07-3.60; P<.001). Compared to the structured design, unstructured design use resulted in significantly more modules completed (MR 1.49, 95\% CI 1.26-1.76; P<.001), home practice activity reviews (MR 7.49, 95\% CI 5.19-10.82; P<.001), modules started (MR 1.27, 95\% CI 1.06-1.52; P=.01), time spent in the app (MR 1.84, 95\% CI 1.70-1.99; P<.001), and positive behavior logs (MR 55.68, 95\% CI 16.48-188.14; P<.001). While analyses did not detect an effect of enhanced digital support on directly observed engagement, the combination of enhanced digital support and guidance positively influenced engagement across a range of outcomes. Conclusions: This study is the first to systematically optimize engagement with a digital parenting intervention in a low- and middle-income country. Our findings offer important learnings for developing evidence-based, scalable digital interventions in resource-constrained settings. Trial Registration: Pan-African Clinical Trial Registry PACTR202210657553944; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 International Registered Report Identifier (IRRID): RR2-10.1186/s12889-023-15989-x ",
doi="10.2196/60102",
url="https://www.jmir.org/2025/1/e60102",
url="http://www.ncbi.nlm.nih.gov/pubmed/40063069"
}


@Article{info:doi/10.2196/59946,
author="Tsai, Chuan-Ching
and Kim, Yong Jin
and Chen, Qiyuan
and Rowell, Brigid
and Yang, Jessie X.
and Kontar, Raed
and Whitaker, Megan
and Lester, Corey",
title="Effect of Artificial Intelligence Helpfulness and Uncertainty on Cognitive Interactions with Pharmacists: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Jan",
day="31",
volume="27",
pages="e59946",
keywords="CDSS",
keywords="eye-tracking",
keywords="medication verification",
keywords="uncertainty visualization",
keywords="AI helpfulness and accuracy",
keywords="artificial intelligence",
keywords="cognitive interactions",
keywords="clinical decision support system",
keywords="cognition",
keywords="pharmacists",
keywords="medication",
keywords="interaction",
keywords="decision-making",
keywords="cognitive processing",
abstract="Background: Clinical decision support systems leveraging artificial intelligence (AI) are increasingly integrated into health care practices, including pharmacy medication verification. Communicating uncertainty in an AI prediction is viewed as an important mechanism for boosting human collaboration and trust. Yet, little is known about the effects on human cognition as a result of interacting with such types of AI advice. Objective: This study aimed to evaluate the cognitive interaction patterns of pharmacists during medication product verification when using an AI prototype. Moreover, we examine the impact of AI's assistance, both helpful and unhelpful, and the communication of uncertainty of AI-generated results on pharmacists' cognitive interaction with the prototype. Methods: In a randomized controlled trial, 30 pharmacists from professional networks each performed 200 medication verification tasks while their eye movements were recorded using an online eye tracker. Participants completed 100 verifications without AI assistance and 100 with AI assistance (either with black box help without uncertainty information or uncertainty-aware help, which displays AI uncertainty). Fixation patterns (first and last areas fixated, number of fixations, fixation duration, and dwell times) were analyzed in relation to AI help type and helpfulness. Results: Pharmacists shifted 19\%-26\% of their total fixations to AI-generated regions when these were available, suggesting the integration of AI advice in decision-making. AI assistance did not reduce the number of fixations on fill images, which remained the primary focus area. Unhelpful AI advice led to longer dwell times on reference and fill images, indicating increased cognitive processing. Displaying AI uncertainty led to longer cognitive processing times as measured by dwell times in original images. Conclusions: Unhelpful AI increases cognitive processing time in the original images. Transparency in AI is needed in ``black box'' systems, but showing more information can add a cognitive burden. Therefore, the communication of uncertainty should be optimized and integrated into clinical workflows using user-centered design to avoid increasing cognitive load or impeding clinicians' original workflow. Trial Registration: ClinicalTrials.gov NCT06795477; https://clinicaltrials.gov/study/NCT06795477 ",
doi="10.2196/59946",
url="https://www.jmir.org/2025/1/e59946",
url="http://www.ncbi.nlm.nih.gov/pubmed/39888668"
}


@Article{info:doi/10.2196/56039,
author="Cho, Ukrae
and Gwon, Nam Yong
and Chong, Ryong Seung
and Han, Yeon Ji
and Kim, Kyung Do
and Doo, Whan Seung
and Yang, Jae Won
and Kim, Kyeongmin
and Shim, Ryul Sung
and Jung, Jaehun
and Kim, Heon Jae",
title="Satisfactory Evaluation of Call Service Using AI After Ureteral Stent Insertion: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2025",
month="Jan",
day="21",
volume="27",
pages="e56039",
keywords="artificial intelligence",
keywords="AI",
keywords="ureteral stent",
keywords="complications",
keywords="randomized controlled trial",
keywords="urologic procedures",
keywords="urology",
keywords="patients",
keywords="information resources",
abstract="Background: Ureteral stents, such as double-J stents, have become indispensable in urologic procedures but are associated with complications like hematuria and pain. While the advancement of artificial intelligence (AI) technology has led to its increasing application in the health sector, AI has not been used to provide information on potential complications and to facilitate subsequent measures in the event of such complications. Objective: This study aimed to assess the effectiveness of an AI-based prediction tool in providing patients with information about potential complications from ureteroscopy and ureteric stent placement and indicating the need for early additional therapy. Methods: Overall, 28 patients (aged 20-70 years) who underwent ureteral stent insertion for the first time without a history of psychological illness were consecutively included. A ``reassurance-call'' service was set up to equip patients with details about the procedure and postprocedure care, to monitor for complications and their severity. Patients were randomly allocated into 2 groups, reassurance-call by AI (group 1) and reassurance-call by humans (group 2). The primary outcome was the level of satisfaction with the reassurance-call service itself, measured using a Likert scale. Secondary outcomes included satisfaction with the AI-assisted reassurance-call service, also measured using a Likert scale, and the level of satisfaction (Likert scale and Visual Analogue Scale [VAS]) and anxiety (State-Trait Anxiety Inventory and VAS) related to managing complications for both groups. Results: Of the 28 recruited patients (14 in each group), 1 patient in group 2 dropped out. Baseline characteristics of patients showed no significant differences (all P>.05). Satisfaction with reassurance-call averaged 4.14 (SD 0.66; group 1) and 4.54 (SD 0.52; group 2), with no significant difference between AI and humans (P=.11). AI-assisted reassurance-call satisfaction averaged 3.43 (SD 0.94). Satisfaction about the management of complications using the Likert scale averaged 3.79 (SD 0.70) and 4.23 (SD 0.83), respectively, showing no significant difference (P=.14), but a significant difference was observed when using the VAS (P=.01), with 6.64 (SD 2.13) in group 1 and 8.69 (SD 1.80) in group 2. Anxiety about complications using the State-Trait Anxiety Inventory averaged 36.43 (SD 9.17) and 39.23 (SD 8.51; P=.33), while anxiety assessed with VAS averaged 4.86 (SD 2.28) and 3.46 (SD 3.38; P=.18), respectively, showing no significant differences. Multiple regression analysis was performed on all outcomes, and humans showed superior satisfaction than AI in the management of complications. Otherwise, most of the other variables showed no significant differences (P.>05). Conclusions: This is the first study to use AI for patient reassurance regarding complications after ureteric stent placement. The study found that patients were similarly satisfied for reassurance calls conducted by AI or humans. Further research in larger populations is warranted to confirm these findings. Trial Registration: Clinical Research Information System KCT0008062; https://tinyurl.com/4s8725w2 ",
doi="10.2196/56039",
url="https://www.jmir.org/2025/1/e56039"
}


@Article{info:doi/10.2196/53740,
author="Leung, Nicholas
and Waki, Kayo
and Nozoe, Satoshi
and Enomoto, Shunpei
and Saito, Ryo
and Hamagami, Sakurako
and Yamauchi, Toshimasa
and Nangaku, Masaomi
and Ohe, Kazuhiko
and Onishi, Yukiko",
title="Efficacy of Save Medical Corporation (SMC)--01, a Smartphone App Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2024",
month="Sep",
day="10",
volume="26",
pages="e53740",
keywords="behavioral change",
keywords="HbA1c",
keywords="hemoglobin A1c",
keywords="mHealth",
keywords="randomized controlled trial",
keywords="smartphone application",
keywords="T2DM",
keywords="diabetes mellitus",
keywords="mobile apps",
keywords="mobile app",
keywords="type 2 diabetes",
keywords="diabetes",
keywords="self-management",
keywords="Japan",
keywords="multi-institutional",
keywords="RCT",
keywords="RCTs",
keywords="efficacy",
keywords="app development",
keywords="safety",
keywords="mobile phone",
abstract="Background: Lifestyle modifications are a key part of type 2 diabetes mellitus treatment. Many patients find long-term self-management difficult, and mobile apps could be a solution. In 2010, in the United States, a mobile app was approved as an official medical device. Similar apps have entered the Japanese market but are yet to be classified as medical devices. Objective: The objective of this study was to determine the efficacy of Save Medical Corporation (SMC)--01, a mobile app for the support of lifestyle modifications among Japanese patients with type 2 diabetes mellitus. Methods: This was a 24-week multi-institutional, prospective randomized controlled trial. The intervention group received SMC-01, an app with functions allowing patients to record data and receive personalized feedback to encourage a healthier lifestyle. The control group used paper journals for diabetes self-management. The primary outcome was the between-group difference in change in hemoglobin A1c from baseline to week 12. Results: The change in hemoglobin A1c from baseline to week 12 was --0.05\% (95\% CI --0.14\% to 0.04\%) in the intervention group and 0.06\% (95\% CI --0.04\% to 0.15\%) in the control group. The between-group difference in change was --0.11\% (95\% CI --0.24\% to 0.03\%; P=.11). Conclusions: There was no statistically significant change in glycemic control. The lack of change could be due to SMC-01 insufficiently inducing behavior change, absence of screening for patients who have high intention to change their lifestyle, low effective usage of SMC-01 due to design issues, or problems with the SMC-01 intervention. Future efforts should focus on these issues in the early phase of developing interventions. Trial Registration: Japan Registry of Clinical Trials jRCT2032200033; https://jrct.niph.go.jp/latest-detail/jRCT2032200033 ",
doi="10.2196/53740",
url="https://www.jmir.org/2024/1/e53740"
}


@Article{info:doi/10.2196/51059,
author="Manz, R. Christopher
and Schriver, Emily
and Ferrell, J. William
and Williamson, Joelle
and Wakim, Jonathan
and Khan, Neda
and Kopinsky, Michael
and Balachandran, Mohan
and Chen, Jinbo
and Patel, S. Mitesh
and Takvorian, U. Samuel
and Shulman, N. Lawrence
and Bekelman, E. Justin
and Barnett, J. Ian
and Parikh, B. Ravi",
title="Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial",
journal="J Med Internet Res",
year="2024",
month="May",
day="17",
volume="26",
pages="e51059",
keywords="wearables",
keywords="accelerometers",
keywords="patient-reported outcomes",
keywords="step counts",
keywords="oncology",
keywords="accelerometer",
keywords="patient-generated health data",
keywords="cancer",
keywords="death",
keywords="chemotherapy",
keywords="symptoms",
keywords="gastrointestinal cancer",
keywords="lung cancer",
keywords="monitoring",
keywords="symptom burden",
keywords="risk",
keywords="hospitalization",
keywords="mobile phone",
abstract="Background: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death. Objective: The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death. Methods: The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care.?This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data. Results: Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42\%) were female, 43 (75\%) had advanced gastrointestinal cancer, 14 (25\%) had advanced lung cancer, and 25 (44\%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95\% CI --277 to --213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change --892), nausea score (--677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20\% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95\% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95\% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95\% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95\% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95\% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16\% greater odds of hospitalization or death (aOR 1.2, 95\% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7\% (n=274 steps), 9\% (n=351 steps), and 16\% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively. Conclusions: In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes. Trial Registration: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-054675 ",
doi="10.2196/51059",
url="https://www.jmir.org/2024/1/e51059",
url="http://www.ncbi.nlm.nih.gov/pubmed/38758583"
}


@Article{info:doi/10.2196/47463,
author="Maiwald, Phillip
and Bischoff, Martina
and Lindinger, Peter
and Tinsel, Iris
and Sehlbrede, Matthias
and Fichtner, Alexander Urs
and Metzner, Gloria
and Schlett, Christian
and Farin-Glattacker, Erik",
title="The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="Nov",
day="21",
volume="25",
pages="e47463",
keywords="eHealth",
keywords="internet-based",
keywords="smoking cessation",
keywords="interactivity",
keywords="tailoring",
keywords="use intensity",
keywords="randomized controlled trial",
keywords="mobile phone",
abstract="Background: eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity. Objective: We examined the effectiveness of Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC), an internet-based, tailored, and interactive SC intervention. Our hypotheses were as follows: hypothesis 1, in the intervention group (IG; access to TK-SCC), a clinically relevant number of participants will be abstinent at the 12-month follow-up (T3); hypothesis 2, the number of abstinent participants will be significantly greater in the IG than the control group (CG) at T3; and hypothesis 3, in the IG, more intense use of TK-SCC will be positively associated with abstinence. Methods: Individuals who smoke were randomized into the IG (563/1115, 50.49\%) or CG (552/1115, 49.51\%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tested hypothesis 1 through equivalence tests between the IG's success rate and success rates of comparable effective interventions reported in 2 current meta-analyses. For hypothesis 2, we conducted binary logistic regressions. For hypothesis 3, we assigned the IG participants to 1 of 4 user types and used binary logistic regressions with user types as the independent variable and smoking abstinence as the dependent variable. Results: In the IG, 11.5\% (65/563) and 11.9\% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9\% (z score=0.64, P=.74) and 10.9\% (z score=?0.71, P=.24) success rates, respectively. In the CG, 6.2\% (34/552) of the participants were smoke free at T1, which increased up to 8.2\% (45/552) at T3. The difference between the IG and CG was statistically significant only at T1 (odds ratio [OR] 2.0, 99\% CI 1.1 to 3.6; P=.002), whereas the effect was nonsignificant following $\alpha$ error corrections at T3 (OR 1.6, 99\% CI 0.9 to 2.7; P=.02). In the IG, constant users of the program became smoke free significantly more often than rare users of the program (T1: OR 15.0, 99\% CI 6.1 to 36.9; P<.001; T3: OR 6.5, 99\% CI 2.8 to 15.5; P<.001). Conclusions: TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additional efforts to motivate users to adhere to intervention use as intended could improve the intervention's effectiveness. Trial Registration: German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-021-05470-8 ",
doi="10.2196/47463",
url="https://www.jmir.org/2023/1/e47463",
url="http://www.ncbi.nlm.nih.gov/pubmed/37988144"
}


@Article{info:doi/10.2196/48968,
author="Mansor, Norain
and Ahmad, Norliza
and Md Said, Salmiah
and Tan, Kit-Aun
and Sutan, Rosnah",
title="Effectiveness of a Theory-Based Digital Animated Video Intervention to Reduce Intention and Willingness to Sext Among Diploma Students: Cluster Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="Oct",
day="20",
volume="25",
pages="e48968",
keywords="sexting",
keywords="randomized controlled trial",
keywords="YouTube",
keywords="intention",
keywords="willingness",
keywords="young adult",
keywords="Malaysia, diploma students",
keywords="digital content",
keywords="digital health intervention",
keywords="attrition rate",
keywords="primary outcome",
keywords="sexual risk",
keywords="sexual health",
keywords="WhatsApp",
abstract="Background: Sexting refers to the exchange of sexually explicit digital content in the form of texts, photos, or videos. In recent years, sexting has become a public health concern. Surveys in Malaysia show a high prevalence of young adults engaged in sexting. Given that sexting is associated with sexual risk behavior, cyberbullying, and mental health issues, this behavior needs intervention to alleviate the resulting public health burden. However, there is a scarcity of theory-based intervention programs on the prevention of intention and willingness to sext among young adults. Objective: This study aimed to develop and implement a sexting intervention module guided by the prototype willingness model (PWM), delivered using web-based animated video, and evaluate its effectiveness among diploma students from a public higher educational institution. The primary outcomes were intention and willingness to sext, while the secondary outcomes were knowledge, attitude, perceived norms, and prototype perceptions of sexting. Methods: This 2-armed, parallel, single-blinded cluster randomized controlled trial was conducted in a public higher educational institution in the state of Melaka, Malaysia. Diploma students from 12 programs were randomly allocated into intervention and control groups. Both groups answered a self-administered web-based questionnaire assessing the outcomes at the baseline. The intervention group received a newly developed intervention module based on the PWM in the form of 5 animated videos posted on a private YouTube platform, while the control group was put on the waitlist. The intervention group was encouraged to discuss any issues raised with the researchers via WhatsApp private chat after viewing the videos. All participants were observed immediately and 3 months postintervention. Data analysis was performed with SPSS (version 26; IBM Corp). A generalized linear mixed model was used to determine the effectiveness of the intervention. Results: There were a total of 300 participants with an attrition rate of 8.3\% (n=25). After adjusting for age, sex, relationship status, and the amount of time spent on the web, there were significant differences in the intention to sext ($\beta$=--.12; P=.002; Cohen d=0.23), willingness to sext ($\beta$=--.16; P<.001; Cohen d=0.40), knowledge ($\beta$=.12; P<.001; Cohen d=0.39), attitude ($\beta$=--.11; P=.001; Cohen d=0.31), perceived norms ($\beta$=--.06; P=.04; Cohen d=0.18), and prototype perceptions ($\beta$=--.11; P<.001; Cohen d=0.35) between the intervention and control groups over 3 months. Conclusions: In this study, the sexting intervention module using the PWM that was delivered via web-based animated videos was effective in reducing intention and willingness to sext as well as in improving knowledge of sexting, attitudes, perceived norms, and prototype perceptions. Therefore, relevant agencies involved in the promotion of sexual and reproductive health among young adults in Malaysia can consider the implementation of this module. Trial Registration: Thai Clinical Trial Registry TCTR20201010002; https://www.thaiclinicaltrials.org/show/TCTR20201002001 ",
doi="10.2196/48968",
url="https://www.jmir.org/2023/1/e48968",
url="http://www.ncbi.nlm.nih.gov/pubmed/37862090"
}


@Article{info:doi/10.2196/40955,
author="Raj, Diana
and Ahmad, Norliza
and Mohd Zulkefli, Afiah Nor
and Lim, Ying Poh",
title="Stop and Play Digital Health Education Intervention for Reducing Excessive Screen Time Among Preschoolers From Low Socioeconomic Families: Cluster Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="May",
day="4",
volume="25",
pages="e40955",
keywords="child",
keywords="preschool",
keywords="screen time",
keywords="mother-child",
keywords="randomized controlled trial",
keywords="mobile phone",
abstract="Background: High prevalence of excessive screen time among preschool children is attributable to certain parental factors such as lack of knowledge, false perception about screen time, and inadequate skills. Lack of strategies to implement screen time guidelines, in addition to multiple commitments that may hinder parents from face-to-face interventions, demands the need to develop a technology-based parent-friendly screen time reduction intervention. Objective: This study aims to develop, implement, and evaluate the effectiveness of Stop and Play, a digital parental health education intervention to reduce excessive screen time among preschoolers from low socioeconomic families in Malaysia. Methods: A single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whiteboard animation videos, infographics, and a problem-solving session, was delivered via WhatsApp (WhatsApp Inc). Primary outcome was the child's screen time, whereas secondary outcomes included mother's screen time knowledge, perception about the influence of screen time on the child's well-being, self-efficacy to reduce the child's screen time and increase physical activity, mother's screen time, and presence of screen device in the child's bedroom. Validated self-administered questionnaires were administered at baseline, immediately after the intervention, and 3 months after the intervention. The intervention's effectiveness was evaluated using generalized linear mixed models. Results: A total of 352 dyads completed the study, giving an attrition rate of 2.2\% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child's screen time compared with the control group ($\beta$=?202.29, 95\% CI ?224.48 to ?180.10; P<.001). Parental outcome scores also improved in the intervention group as compared with that in the control group. Mother's knowledge significantly increased ($\beta$=6.88, 95\% CI 6.11-7.65; P<.001), whereas perception about the influence of screen time on the child's well-being reduced ($\beta$=?.86, 95\% CI ?0.98 to ?0.73; P<.001). There was also an increase in the mother's self-efficacy to reduce screen time ($\beta$=1.59, 95\% CI 1.48-1.70; P<.001) and increase physical activity ($\beta$=.07, 95\% CI 0.06-0.09; P<.001), along with reduction in mother's screen time ($\beta$=?70.43, 95\% CI ?91.51 to ?49.35; P<.001). Conclusions: The Stop and Play intervention was effective in reducing screen time among preschool children from low socioeconomic families, while improving the associated parental factors. Therefore, integration into primary health care and preschool education programs is recommended. Mediation analysis is suggested to investigate the extent to which secondary outcomes are attributable to the child's screen time, and long follow-up could evaluate the sustainability of this digital intervention. Trial Registration: Thai Clinical Trial Registry (TCTR) TCTR20201010002; https://tinyurl.com/5frpma4b ",
doi="10.2196/40955",
url="https://www.jmir.org/2023/1/e40955",
url="http://www.ncbi.nlm.nih.gov/pubmed/37140970"
}


@Article{info:doi/10.2196/40472,
author="Melisse, Bernou
and Berg, den Elske van
and Jonge, de Margo
and Blankers, Matthijs
and Furth, van Eric
and Dekker, Jack
and Beurs, de Edwin",
title="Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy--Enhanced for Binge Eating Disorder: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="May",
day="1",
volume="25",
pages="e40472",
keywords="randomized controlled trial",
keywords="RCT",
keywords="binge eating disorder",
keywords="BED",
keywords="guided self-help",
keywords="cognitive behavioral therapy--enhanced",
keywords="CBT-E",
abstract="Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy--enhanced (CBT-E) may have great advantages for patients if its efficacy can be established. Objective: The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition. Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50\%) or the delayed-treatment control condition (n=90, 50\%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination--Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions. Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40\% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9\%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition. Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Trial Registration: Netherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-020-02604-1 ",
doi="10.2196/40472",
url="https://www.jmir.org/2023/1/e40472",
url="http://www.ncbi.nlm.nih.gov/pubmed/37126386"
}


@Article{info:doi/10.2196/40595,
author="Seki, Tomotsugu
and Aki, Morio
and Furukawa, A. Toshi
and Kawashima, Hirotsugu
and Miki, Tomotaka
and Sawaki, Yujin
and Ando, Takaaki
and Katsuragi, Kentaro
and Kawashima, Takahiko
and Ueno, Senkei
and Miyagi, Takashi
and Noma, Shun'ichi
and Tanaka, Shiro
and Kawakami, Koji",
title="Electronic Health Record--Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="Mar",
day="22",
volume="25",
pages="e40595",
keywords="electronic health record",
keywords="lithium",
keywords="mood disorders",
keywords="randomized controlled trial",
keywords="quality of health care",
abstract="Background: Clinical guidelines recommend regular serum lithium monitoring every 3 to 6 months. However, in the real world, only a minority of patients receive adequate monitoring. Objective: This study aims to examine whether the use of the electronic health record (EHR)--nested reminder system for serum lithium monitoring can help achieve serum lithium concentrations within the therapeutic range for patients on lithium maintenance therapy. Methods: We conducted an unblinded, single-center, EHR-nested, parallel-group, superiority randomized controlled trial comparing EHR-nested reminders with usual care in adult patients receiving lithium maintenance therapy for mood disorders. The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. The key secondary outcomes are included as follows: the number of serum lithium level monitoring except for the first and final monitoring; exacerbation of the mood disorder during the study period, defined by hospitalization, increase in lithium dose, addition of antipsychotic drugs or mood stabilizers, or addition or increase of antidepressants; adherence defined by the proportion of days covered by lithium carbonate prescription during the study period. Results: A total of 111 patients were enrolled in this study. A total of 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group. At the follow-up, 38 (69.1\%) patients in the reminder group and 33 (60.0\%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95\% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95\% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5\%) patients in the reminder group and in 16 (34.8\%) patients in the usual care group (odds ratio 0.97, 95\% CI 0.42-2.28, P=.95). Conclusions: We found insufficient evidence for an EHR-nested reminder to increase the achievement of therapeutic serum lithium concentrations. However, the number of monitoring increased with relatively simple and inexpensive intervention. The EHR-based reminders may be useful to improve quality of care for patients on lithium maintenance therapy, and they have potentials to be applied to other problems. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000033633; https://tinyurl.com/5n7wtyav ",
doi="10.2196/40595",
url="https://www.jmir.org/2023/1/e40595",
url="http://www.ncbi.nlm.nih.gov/pubmed/36947138"
}


@Article{info:doi/10.2196/43634,
author="Lee, Kyong-No
and Kim, Ji Hyeon
and Choe, Kiroong
and Cho, Aeri
and Kim, Bohyoung
and Seo, Jinwook
and Myung, Woojae
and Park, Yoon Jee
and Oh, Joon Kyung",
title="Effects of Fetal Images Produced in Virtual Reality on Maternal-Fetal Attachment: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="Feb",
day="24",
volume="25",
pages="e43634",
keywords="maternal-fetal attachment",
keywords="virtual reality",
keywords="ultrasound",
keywords="pregnancy",
keywords="fetus",
keywords="postpartum depression",
keywords="pediatric",
keywords="mobile app",
keywords="mental well-being",
keywords="mobile health app",
keywords="maternal health",
keywords="women's health",
abstract="Background: Maternal-fetal attachment (MFA) has been reported to be associated with the postpartum mother-infant relationship. Seeing the fetus through ultrasound might influence MFA, and the effect could be increased by more realistic images, such as those generated in virtual reality (VR). Objective: The aim was to determine the effect of fetal images generated in VR on MFA and depressive symptoms through a prenatal-coaching mobile app. Methods: This 2-arm parallel randomized controlled trial involved a total of 80 pregnant women. Eligible women were randomly assigned to either a mobile app--only group (n=40) or an app plus VR group (n=40). The VR group experienced their own baby's images generated in VR based on images obtained from fetal ultrasonography. The prenatal-coaching mobile app recommended health behavior for the pregnant women according to gestational age, provided feedback on entered data for maternal weight, blood pressure, and glucose levels, and included a private diary service for fetal ultrasound images. Both groups received the same app, but the VR group also viewed fetal images produced in VR; these images were stored in the app. All participants filled out questionnaires to assess MFA, depressive symptoms, and other basic medical information. The questionnaires were filled out again after the interventions. Results: Basic demographic data were comparable between the 2 groups. Most of the assessments showed comparable results for the 2 groups, but the mean score to assess interaction with the fetus was significantly higher for the VR group than the control group (0.4 vs 0.1, P=.004). The proportion of participants with an increased score for this category after the intervention was significantly higher in the VR group than the control group (43\% vs 13\%, P=.005). The feedback questionnaire revealed that scores for the degree of perception of fetal appearance all increased after the intervention in the VR group. Conclusions: The use of a mobile app with fetal images in VR significantly increased maternal interaction with the fetus. Trial Registration: ClinicalTrials.gov NCT04942197; https://clinicaltrials.gov/ct2/show/NCT04942197 ",
doi="10.2196/43634",
url="https://www.jmir.org/2023/1/e43634",
url="http://www.ncbi.nlm.nih.gov/pubmed/36826976"
}


@Article{info:doi/10.2196/43885,
author="Shorey, Shefaly
and Chong, Seng Yap
and Shi, Luming
and Chua, Shi Jing
and 
and Mathews, Jancy
and Lim, Hoon Siew
and Du, Ruochen
and Chan, Huak Yiong
and Tan, Chye Thiam
and Chee, Cornelia
and Law, Evelyn",
title="Evaluating the Effects of the Supportive Parenting App on Infant Developmental Outcomes: Longitudinal Study",
journal="JMIR Mhealth Uhealth",
year="2023",
month="Feb",
day="22",
volume="11",
pages="e43885",
keywords="infant development",
keywords="parenting",
keywords="mobile health technology",
keywords="social support",
keywords="psychoeducation",
keywords="peer support",
keywords="mobile phone",
abstract="Background: Previous studies have investigated the various effects of parenting on infant developmental outcomes. In particular, parental stress and social support have been found to significantly affect the growth of the newborn. Although many parents today use mobile apps to obtain more support in parenting and perinatal care, few studies have examined how these apps could affect infant development. Objective: This study aimed to examine the effectiveness of the Supportive Parenting App (SPA) in improving infant developmental outcomes during the perinatal period. Methods: This study adopted a 2-group parallel prospective longitudinal design and recruited 200 infants and their parents (N=400 mothers and fathers). The parents were recruited at 24 weeks of gestation for a randomized controlled trial conducted from February 2020 to July 2022. They were randomly allocated to either the intervention or control group. The infant outcome measures included cognition, language, motor skills, and social-emotional development. Data were collected from the infants when they were aged 2, 4, 6, 9, and 12 months. Linear and modified Poisson regressions were used to analyze the data to examine between- and within-group changes. Results: At 9 and 12 months post partum, the infants in the intervention group were found to have better communication and language skills than those in the control group. An analysis of motor development revealed that a larger proportion of the infants in the control group fell under the at-risk category, where they scored approximately 2 SDs below the normative scores. The control group infants scored higher on the problem solving domain at 6 months post partum. However, at 12 months postpartum, the infants in the intervention group performed better on cognitive tasks than those in the control group. Despite not being statistically significant, the intervention group infants were found to have consistently scored better on the social components of the questionnaires than the control group infants. Conclusions: Overall, the infants whose parents had received the SPA intervention tended to fare better in most developmental outcome measures than those whose parents had received standard care only. The findings of this study suggest that the SPA intervention exerted positive effects on the communication, cognition, motor, and socioemotional development of the infants. Further research is needed to improve the content and support provided by the intervention to maximize the benefits gained by infants and their parents. Trial Registration: ClinicalTrials.gov NCT04706442; https://clinicaltrials.gov/ct2/show/NCT04706442 ",
doi="10.2196/43885",
url="https://mhealth.jmir.org/2023/1/e43885",
url="http://www.ncbi.nlm.nih.gov/pubmed/36811952"
}


@Article{info:doi/10.2196/38619,
author="Le Du, Katell
and Septans, Anne-Lise
and Maloisel, Fr{\'e}d{\'e}ric
and Vanquaethem, H{\'e}l{\`e}ne
and Schmitt, Anna
and Le Goff, Marielle
and Clavert, Aline
and Zinger, Marie
and Bourgeois, Hugues
and Dupuis, Olivier
and Denis, Fabrice
and Bouchard, St{\'e}phane",
title="A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study",
journal="J Med Internet Res",
year="2023",
month="Feb",
day="15",
volume="25",
pages="e38619",
keywords="virtual reality",
keywords="VR",
keywords="bone marrow",
keywords="biopsy",
keywords="pain",
keywords="digital therapeutics",
keywords="digital health",
keywords="eHealth",
keywords="RCT",
keywords="randomized controlled trial",
keywords="clinical trial",
keywords="distraction",
keywords="imagery",
keywords="imagination",
keywords="imaginary",
keywords="immersive environment",
keywords="interactive environment",
keywords="head-mounted display",
keywords="medical procedure",
keywords="satisfaction",
keywords="safety",
keywords="efficacy",
keywords="effectiveness",
abstract="Background: Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed. Objective: In this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy. Methods: Bliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed. Results: Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants' median age was 65.5 (range 18-87) years, and 54.2\% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95\% CI --1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95\% CI --1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy (P=.26). Concerning anxiety, 67.5\% (79/117; fear of pain questionnaire) of the patients were afraid before the biopsy, and anxiety scores were moderate to very high in 26.3\% (30/114; revised Spielberger State-Trait Anxiety Inventory questionnaire) of the patients before the biopsy and 9.0\% (10/114) after the biopsy for all patients, without a significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority (54/57, 95\%) of patients in the VR group. Conclusions: The intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA. Trial Registration: ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194 ",
doi="10.2196/38619",
url="https://www.jmir.org/2023/1/e38619",
url="http://www.ncbi.nlm.nih.gov/pubmed/36790852"
}


@Article{info:doi/10.2196/41859,
author="Shorey, Shefaly
and Law, Evelyn
and 
and Mathews, Jancy
and Lim, Hoon Siew
and Shi, Luming
and Chua, Shi Jing
and Du, Ruochen
and Chan, Huak Yiong
and Tan, Chye Thiam
and Chee, Cornelia
and Chong, Seng Yap",
title="Evaluating the Effectiveness of the Supportive Parenting App on Parental Outcomes: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2023",
month="Jan",
day="16",
volume="25",
pages="e41859",
keywords="postnatal depression",
keywords="mobile health technology",
keywords="social support",
keywords="COVID-19",
keywords="psychoeducation",
keywords="peer support",
keywords="mobile phone",
abstract="Background: Adjusting to new or additional parenting responsibilities increases stress and affects parental well-being. Existing research has highlighted both parents' desire to receive more support. It has also been found that receiving sufficient social support enhances parenting outcomes. With the increasing popularity of mobile health apps, a Supportive Parenting App (SPA) intervention was developed to fulfill the support needs of parents during the perinatal period. Objective: This study aimed to examine the effectiveness of the SPA on parental outcomes during the perinatal period. Methods: A 2-group pretest and repeated posttest randomized controlled trial was conducted wherein 200 couples (N=400 mothers and fathers) were recruited from 2 public health care institutions in Singapore. Parents were randomly assigned to intervention (100/200, 50\%) or control (100/200, 50\%) groups. The SPA intervention consisted of a mobile app--based psychoeducation and peer support program to support parents from pregnancy to 6 months post partum. The outcome measures included postnatal depression, anxiety, parental bonding, parental self-efficacy, perceived social support, and parenting satisfaction. Data were collected at baseline (at >24 weeks of gestation---age of viability in Singapore) and at the first, second, fourth, sixth, ninth, and 12th month post partum. Linear mixed models were used to compare parental outcomes between the groups, and a linear mixed model for repeated measures was used to examine within-group changes. Results: Parents in the intervention group mostly showed better outcomes compared with those in the control group. Parents in the intervention group had higher perceived social support than those in the control group at the first (effect size=1.59, 95\% CI 0.38-2.80; Cohen standardized effect size=1.31; P=.01), second (effect size=1.98, 95\% CI 1.09-2.88; Cohen standardized effect size=2.21; P=.003), and fourth (effect size=2.57, 95\% CI 1.62-3.51; Cohen standardized effect size=2.72; P=.048) months post partum. However, parents in the intervention group showed significantly poorer parental bonding (effect size=1.67, 95\% CI 0.24-3.11; Cohen standardized effect size=1.16; P=.02). The other parental outcomes did not differ significantly between groups. The scores of mothers and fathers also differed significantly for all outcomes except parental self-efficacy. Conclusions: Parents in the intervention group generally fared better, especially regarding perceived social support. However, the lack of statistical significance in most outcomes showed the limited effectiveness of the SPA intervention, which may be because of the COVID-19 pandemic. Parental differences in outcome scores suggest that mothers and fathers have different support needs; therefore, interventions should be tailored accordingly. Further improvements and evaluations are needed to examine the effectiveness of the SPA intervention in enhancing parental outcomes. Despite statistically insignificant results, limitations should be considered to further improve mobile health app--based interventions such as SPA, as they could serve as reliable and convenient sources of support for parents. Trial Registration: Clinicaltrails.gov NCT4706442; https://clinicaltrials.gov/ct2/show/NCT04706442 ",
doi="10.2196/41859",
url="https://www.jmir.org/2023/1/e41859",
url="http://www.ncbi.nlm.nih.gov/pubmed/36645699"
}


@Article{info:doi/10.2196/40292,
author="Vitger, Tobias
and Hjorth{\o}j, Carsten
and Austin, F. Stephen
and Petersen, Lone
and T{\o}nder, Sandvik Esben
and Nordentoft, Merete
and Korsbek, Lisa",
title="A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial",
journal="J Med Internet Res",
year="2022",
month="Oct",
day="26",
volume="24",
number="10",
pages="e40292",
keywords="mobile health",
keywords="mHealth",
keywords="digital intervention",
keywords="shared decision-making",
keywords="patient activation",
keywords="schizophrenia",
keywords="schizotypal",
keywords="early intervention",
keywords="randomized clinical trial",
keywords="mobile phone",
abstract="Background: Shared decision-making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and provider are actively involved in treatment decisions. In mental health care, SDM has been advocated as a means for the patient to gain or regain control and responsibility over their life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, and reminders. Objective: In this randomized controlled trial, we aimed to investigate the effect of a digital tool to support patient activation and SDM. Methods: The trial was designed as a randomized, assessor-blinded, 2-armed, parallel-group multicenter trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from 9 outpatient treatment sites in the Capital Region of Denmark. The primary outcome was the self-reported level of activation at the postintervention time point. The secondary outcomes included self-efficacy, hope, working alliance, satisfaction, preparedness for treatment consultation, symptom severity, and level of functioning. Explorative outcomes on the effect of the intervention at the midintervention time point along with objective data on the use of the digital tool were collected. Results: In total, 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference 4.39, 95\% CI 0.99-7.79; Cohen d=0.33; P=.01), confidence in communicating with one's provider (mean difference 1.85, 95\% CI 0.01-3.69; Cohen d=0.24; P=.05), and feeling prepared for decision-making (mean difference 5.12, 95\% CI 0.16-10.08; Cohen d=0.27; P=.04). We found no effect of the digital SDM tool on treatment satisfaction, hope, self-efficacy, working alliance, severity of symptoms, level of functioning, use of antipsychotic medicine, and number or length of psychiatric hospital admissions. Conclusions: This trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one's provider, and feeling prepared for decision-making at the postintervention time point. The effect size was smaller than the 0.42 effect size that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental health care. Trial Registration: ClinicalTrials.gov NCT03554655; https://clinicaltrials.gov/ct2/show/NCT03554655 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2143-2 ",
doi="10.2196/40292",
url="https://www.jmir.org/2022/10/e40292",
url="http://www.ncbi.nlm.nih.gov/pubmed/36287604"
}


@Article{info:doi/10.2196/38710,
author="Marshall, J. Nell
and Lee, L. Jennifer
and Schroeder, Jessica
and Lee, Wei-Nchih
and See, Jermyn
and Madjid, Mohammad
and Munagala, R. Mrudula
and Piette, D. John
and Tan, Litjen
and Vardeny, Orly
and Greenberg, Michael
and Liska, Jan
and Mercer, Monica
and Samson, Sandrine",
title="Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Oct",
day="7",
volume="24",
number="10",
pages="e38710",
keywords="influenza",
keywords="randomized trial",
keywords="public health",
keywords="cardiovascular disease",
keywords="immunization",
keywords="vaccination",
keywords="digital messaging",
keywords="digital intervention",
keywords="mobile health",
keywords="mHealth",
abstract="Background: Seasonal influenza affects 5\% to 15\% of Americans annually, resulting in preventable deaths and substantial economic impact. Influenza infection is particularly dangerous for people with cardiovascular disease, who therefore represent a priority group for vaccination campaigns. Objective: We aimed to assess the effects of digital intervention messaging on self-reported rates of seasonal influenza vaccination. Methods: This was a randomized, controlled, single-blind, and decentralized trial conducted at individual locations throughout the United States over the 2020-2021 influenza season. Adults with self-reported cardiovascular disease who were members of the Achievement mobile platform were randomized to receive or not receive a series of 6 patient-centered digital intervention messages promoting influenza vaccination. The primary end point was the between-group difference in self-reported vaccination rates at 6 months after randomization. Secondary outcomes included the levels of engagement with the messages and the relationship between vaccination rates and engagement with the messages. Subgroup analyses examined variation in intervention effects by race. Controlling for randomization group, we examined the impact of other predictors of vaccination status, including cardiovascular condition type, vaccine drivers or barriers, and vaccine knowledge. Results: Of the 49,138 randomized participants, responses on the primary end point were available for 11,237 (22.87\%; 5575 in the intervention group and 5662 in the control group) participants. The vaccination rate was significantly higher in the intervention group (3418/5575, 61.31\%) than the control group (3355/5662, 59.25\%; relative risk 1.03, 95\% CI 1.004-1.066; P=.03). Participants who were older, more educated, and White or Asian were more likely to report being vaccinated. The intervention was effective among White participants (P=.004) but not among people of color (P=.42). The vaccination rate was 13 percentage points higher among participants who completed all 6 intervention messages versus none, and at least 2 completed messages appeared to be needed for effectiveness. Participants who reported a diagnosis of COVID-19 were more likely to be vaccinated for influenza regardless of treatment assignment. Conclusions: This personalized, evidence-based digital intervention was effective in increasing vaccination rates in this population of high-risk people with cardiovascular disease. Trial Registration: ClinicalTrials.gov NCT04584645; https://clinicaltrials.gov/ct2/show/NCT04584645 ",
doi="10.2196/38710",
url="https://www.jmir.org/2022/10/e38710",
url="http://www.ncbi.nlm.nih.gov/pubmed/36206046"
}


@Article{info:doi/10.2196/37728,
author="van Steenbergen, Gijs
and van Veghel, Dennis
and van Lieshout, Dideke
and Sperwer, Merel
and ter Woorst, Joost
and Dekker, Lukas",
title="Effects of Video-Based Patient Education and Consultation on Unplanned Health Care Utilization and Early Recovery After Coronary Artery Bypass Surgery (IMPROV-ED): Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Aug",
day="26",
volume="24",
number="8",
pages="e37728",
keywords="e-Health",
keywords="eHealth",
keywords="digital health",
keywords="patient education",
keywords="coronary artery bypass surgery",
keywords="cardiac surgery",
keywords="health care utilization",
keywords="costs",
keywords="cost",
keywords="economic",
keywords="coronary",
keywords="cardiology",
keywords="heart",
keywords="surgery",
keywords="bypass",
keywords="RCT",
keywords="randomized controlled trial",
keywords="video consultation",
keywords="telehealth",
keywords="telemedicine",
keywords="patient-reported",
keywords="recovery",
keywords="expense",
abstract="Background: Health care utilization after coronary artery bypass graft (CABG) surgery is high and is partly of an unplanned nature. eHealth applications have been proposed to reduce care consumption, which involve and assist patients in their recovery. In this way, health care expenses could be reduced and quality of care could be improved. Objective: The aim of this study was to evaluate if an eHealth program can reduce unplanned health care utilization and improve mental and physical health in the first 6 weeks after CABG surgery. Methods: A single-blind randomized controlled trial was performed, in which patients scheduled for nonacute CABG surgery were included from a single center in the Netherlands between February 2020 and October 2021. Participants in the intervention group had, alongside standard care, access to an eHealth program consisting of online education videos and video consultations developed in conjunction with the Dutch Heart Foundation. The control group received standard care. The primary outcome was the volume and costs of a composite of unplanned health care utilization, including emergency department visits, outpatient clinic visits, rehospitalization, patient-initiated telephone consultations, and visits to a general practitioner, measured using the Medical Technology Assessment Medical Consumption Questionnaire. Patient-reported anxiety and recovery were also assessed. Intention-to-treat and ``users-only'' analyses were used. Results: During the study period, 280 patients were enrolled and randomly allocated at a 1:1 ratio to the intervention or control group. The intention-to-treat analysis consisted of 136 and 135 patients in the intervention and control group, respectively. At 6 weeks, the primary endpoint had occurred in 43 of 136 (31.6\%) patients in the intervention group and in 61 of 135 (45.2\%) patients in the control group (hazard ratio 0.56, 95\% CI 0.34-0.92). Recovery was faster in the intervention group, whereas anxiety was similar between study groups. ``Users-only'' analysis yielded similar results. Conclusions: An eHealth strategy comprising educational videos and video consultations can reduce unplanned health care utilization and can aid in faster patient-reported recovery in patients following CABG surgery. Trial Registration: Netherlands Trial Registry NL8510;  https://trialsearch.who.int/Trial2.aspx?TrialID=NL8510 International Registered Report Identifier (IRRID): RR2-10.1007/s12471-020-01508-9 ",
doi="10.2196/37728",
url="https://www.jmir.org/2022/8/e37728",
url="http://www.ncbi.nlm.nih.gov/pubmed/36018625"
}


@Article{info:doi/10.2196/37699,
author="Knudsen, Place Signe de
and Alomairah, Abdulaziz Saud
and Roland, Borup Caroline
and Jessen, Dsane Anne
and Hergel, Ida-Marie
and Clausen, D. Tine
and Larsen, Eg Jakob
and van Hall, Gerrit
and Jensen, Kryger Andreas
and Molsted, Stig
and Bendix, M. Jane
and L{\o}kkegaard, Ellen
and Stallknecht, Bente",
title="Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women's Physical Activity Level: FitMum - Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Jul",
day="20",
volume="24",
number="7",
pages="e37699",
keywords="motivation",
keywords="physical activity",
keywords="pregnancy",
keywords="pregnant",
keywords="RCT",
keywords="randomized controlled trial",
keywords="intervention",
keywords="commercial activity tracker",
keywords="tracker",
keywords="COVID-19",
keywords="maternal health",
keywords="doubly labeled water",
keywords="physical activity questionnaire",
keywords="women's health",
keywords="maternal",
keywords="maternity",
keywords="digital health",
keywords="exercise",
keywords="fitness",
keywords="health outcome",
abstract="Background: Physical activity (PA) during pregnancy is an effective and safe way to improve maternal health in uncomplicated pregnancies. However, compliance with PA recommendations remains low among pregnant women. Objective: The purpose of this study was to evaluate the effects of offering structured supervised exercise training (EXE) or motivational counseling on PA (MOT) during pregnancy on moderate-to-vigorous intensity physical activity (MVPA) level. Additionally, complementary measures of PA using the Pregnancy Physical Activity Questionnaire (PPAQ) and gold standard doubly labeled water (DLW) technique were investigated. The hypotheses were that both EXE and MOT would increase MVPA in pregnancy compared with standard care (CON) and that EXE would be more effective than MOT. In addition, the association between MVPA and the number of sessions attended was explored. Methods: A randomized controlled trial included 220 healthy, inactive pregnant women with a median gestational age of 12.9 (IQR 9.4-13.9) weeks. A total of 219 women were randomized to CON (45/219), EXE (87/219), or MOT (87/219). The primary outcome was MVPA (minutes per week) from randomization to the 29th gestational week obtained by a wrist-worn commercial activity tracker (Vivosport, Garmin International). PA was measured by the activity tracker throughout pregnancy, PPAQ, and DLW. The primary outcome analysis was performed as an analysis of covariance model adjusting for baseline PA. Results: The average MVPA (minutes per week) from randomization to the 29th gestational week was 33 (95\% CI 18 to 47) in CON, 50 (95\% CI 39 to 60) in EXE, and 40 (95\% CI 30 to 51) in MOT. When adjusted for baseline MVPA, participants in EXE performed 20 (95\% CI 4 to 36) minutes per week more MVPA than participants in CON (P=.02). MOT was not more effective than CON; EXE and MOT also did not differ. MVPA was positively associated with the number of exercise sessions attended in EXE from randomization to delivery (P=.04). Attendance was higher for online (due to COVID-19 restrictions) compared with physical exercise training (P=.03). Adverse events and serious adverse events did not differ between groups. Conclusions: Offering EXE was more effective than CON to increase MVPA among pregnant women, whereas offering MOT was not. MVPA in the intervention groups did not reach the recommended level in pregnancy. Changing the intervention to online due to COVID-19 restrictions did not affect MVPA level but increased exercise participation. Trial Registration: ClinicalTrials.gov NCT03679130; https://clinicaltrials.gov/ct2/show/NCT03679130 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2020-043671 ",
doi="10.2196/37699",
url="https://www.jmir.org/2022/7/e37699",
url="http://www.ncbi.nlm.nih.gov/pubmed/35857356"
}


@Article{info:doi/10.2196/26569,
author="Muuraiskangas, Tuulikki Salla
and Honka, Marianne Anita
and Junno, Ulla-Maija
and Nieminen, Olavi Hannu
and Kaartinen, Kalevi Jouni",
title="A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Jul",
day="13",
volume="24",
number="7",
pages="e26569",
keywords="health behavior change intervention",
keywords="telephone coaching",
keywords="technology-assisted coaching",
keywords="remote coaching",
keywords="occupational health",
keywords="mental well-being",
keywords="stress management",
keywords="feasibility",
keywords="randomized controlled trial",
abstract="Background: Stress management interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions, but few randomized controlled trials exist for assessing the cost-effectiveness of technology-assisted human interventions. Objective: The aim of this study was to investigate whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing the time use of coaches (as an approximation of intervention cost) while maintaining participants' adherence and satisfaction compared with traditional telephone coaching. Methods: A 2-arm, pilot randomized controlled trial of 9 months for stress management (4-month intensive and 5-month maintenance phases) was conducted. Participants were recruited on the web through a regional occupational health care provider and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. The coaching methodology was based on habit formation, motivational interviewing, and the transtheoretical model. For the research group, technology supported both coaches and participants in identifying behavior change targets, setting the initial coaching plan, monitoring progress, and communication. The pilot outcome was intervention feasibility, measured primarily by self-assessed mental well-being (WorkOptimum index) and self-reported time use of coaches and secondarily by participants' adherence and satisfaction. Results: A total of 49 eligible participants were randomized to the research (n=24) and control (n=25) groups. Most participants were middle-aged (mean 46.26, SD 9.74 years) and female (47/49, 96\%). Mental well-being improved significantly in both groups (WorkOptimum from ``at risk'' to ``good'' {\^A}>0.85; P<.001), and no between-group differences were observed in the end ({\^A}=0.56, 95\% CI 0.37-0.74; P=.56). The total time use of coaches did not differ significantly between the groups (366.0 vs 343.0 minutes, {\^A}=0.60, 95\% CI 0.33-0.85; P=.48). Regarding adherence, the dropout rate was 13\% (3/24) and 24\% (6/25), and the mean adherence rate to coaching calls was 92\% and 86\% for the research and control groups, respectively; the frequency of performing coaching tasks was similar for both groups after both phases; and the diligence in performing the tasks during the intensive phase was better for the research group (5.0 vs 4.0, {\^A}=0.58, 95\% CI 0.51-0.65; P=.03), but no difference was observed during the maintenance phase. Satisfaction was higher in the research group during the intensive phase (5.0 vs 4.0, {\^A}=0.66, 95\% CI 0.58-0.73; P<.001) but not during the maintenance phase. Conclusions: The technology-assisted telephone intervention is feasible with some modifications, as it had similar preliminary effectiveness as the traditional telephone intervention, and the participants had better satisfaction with and similar or better adherence to the intervention, but it did not reduce the time use of coaches. The technology should be improved to provide more digested information for action planning and templates for messaging. Trial Registration: ClinicalTrials.gov NCT02445950; https://www.clinicaltrials.gov/ct2/show/study/NCT02445950 ",
doi="10.2196/26569",
url="https://www.jmir.org/2022/7/e26569",
url="http://www.ncbi.nlm.nih.gov/pubmed/35830233"
}


@Article{info:doi/10.2196/35869,
author="Kwan, Ho Tsz
and Chan, Chung Denise Pui
and Lee, Shan Shui",
title="User Experience and Usability of Neumorphism and Gamification User Interface Designs in an HIV Self-Test Referral Program for Men Who Have Sex With Men: Prospective Open-Label Parallel-Group Randomized Controlled Trial",
journal="JMIR Serious Games",
year="2022",
month="Jun",
day="22",
volume="10",
number="2",
pages="e35869",
keywords="HIV",
keywords="self-test",
keywords="men who have sex with men",
keywords="gamification",
keywords="neumorphism",
keywords="digital intervention",
keywords="HIV prevention",
keywords="user interface",
keywords="games",
keywords="digital health",
abstract="Background: Digital interventions have been applied for promoting HIV prevention and care among men who have sex with men (MSM). As user interface (UI) design plays a role in determining usability and user experience (UX), the intervention outcome could be affected. Objective: In this study, we hypothesized that 2 UI design styles, namely gamification and neumorphism, could impact usability and be differentially preferred by distinct groups of MSM. Methods: A prospective parallel-group open-label randomized controlled trial was conducted in Hong Kong. Eligible participants were adult MSM recruited by the research team or referred by enrolled participants, who followed instructions for performing an HIV self-test and promoted its use within their social network. Participants were randomized in a 1:1 ratio into either a gamification or neumorphism arm, with primarily visual differences in the UI only. The primary outcome was usability measured by the System Usability Scale (SUS) between the 2 arms. Distinct characteristics of promoters in the 2 arms who gave an SUS score of 80 or above were identified. Results: Of 463 MSM registered in the study, 232 and 231 were randomized to the gamification and neumorphism arms, respectively. Excluding those who did not request a self-test kit, data from 218 and 216 participants in the gamification and neumorphism arms, respectively, were analyzed (totally 434 participants). With a median SUS score of 80 overall, participants in the neumorphism arm gave a higher score (P<.001), with a higher proportion giving a promoter-level SUS score (P=.002). Promoters used social media for sex networking (P=.02), used pre-exposure prophylaxis in the preceding year (P=.006), had higher satisfaction in UI design (P<.001), and had made a self-test referral (P=.04). In general, higher usability was recorded among participants who were confident in performing the HIV self-test (P<.001), and this was associated with a promoter-level SUS score in both arms. While no other personal characteristics were associated with promoters in the neumorphism arm, those in the gamification arm had higher HIV-related knowledge (P=.01), preferred a specific partner body image type (P=.03), and progressed toward peer referral by completing online training (P=.04). Conclusions: Both gamified and neumorphic UI designs were well-accepted by MSM. UX and satisfaction of UI were both crucial in influencing the willingness of MSM to promote the application by referring their peers in the community to participate. The simplistic visual design of neumorphism conferred a more general acceptance in the community, whereas gamification was preferred in certain MSM subcommunities. Appropriate UI/UX design should be considered when developing digital interventions targeting the MSM community. Trial Registration: ClinicalTrials.gov NCT04379206; https://clinicaltrials.gov/ct2/show/NCT04379206 ",
doi="10.2196/35869",
url="https://games.jmir.org/2022/2/e35869",
url="http://www.ncbi.nlm.nih.gov/pubmed/35731564"
}


@Article{info:doi/10.2196/29640,
author="Fillol, Florie
and Paris, Ludivine
and Pascal, S{\'e}bastien
and Mulliez, Aur{\'e}lien
and Roques, Christian-Fran{\c{c}}ois
and Rousset, Sylvie
and Duclos, Martine",
title="Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Jun",
day="16",
volume="24",
number="6",
pages="e29640",
keywords="physical activity",
keywords="spa",
keywords="mobile phone",
keywords="older adults",
keywords="internet",
keywords="exercise",
keywords="aged",
keywords="sedentary behavior",
keywords="quality of life",
keywords="follow-up studies",
abstract="Background: Lack of physical activity (PA) and sedentary behaviors are leading risk factors for noncommunicable diseases (NCDs). Web- and smartphone-based interventions are effective in increasing PA in older adults and in patients with NCD. In many countries, spa therapy, commonly prescribed to patients with NCD, represents an ideal context to initiating lifestyle changes. Objective: This study aimed to evaluate, in patients attending spa therapy, the effectiveness of an intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program on the achievement of PA guidelines (PAG) 12 months after the end of spa therapy. Methods: This was a 12-month, prospective, parallel-group randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received PA usual advice. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants were assessed by phone every 2 months. Primary outcome was meeting PAG (PA ?600 metabolic equivalent of task) at 12 months. Secondary outcomes were meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life at 6 and 12 months. Objective use data of the web- and smartphone-based PA program were collected. Analytic methods included intention to treat and constrained longitudinal data analyses. Results: The study sample included 228 participants (n=176, 77.2\% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m2. Approximately 53.9\% (123/228) of the participants were retired. No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group than in the control group (81\% vs 67\% respectively, odds ratio 2.34, 95\% CI 1.02-5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in the intervention group than in the control group (mean difference: 4.1, 95\% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 (SD 4.5) months. Attrition rate during the first 2 months was 20.4\% (23/113) whereas 39.8\% (45/113) of the participants used the program for at least 10 months. Conclusions: PA increased in both the intervention group and the control group. However, at 12 months, more participants met PAG in the intervention group compared with the controls. This indicates that the web- and smartphone-based program could have maintained PA in the intervention group. In addition, a spa therapy seems to be an ideal time and framework to implement PA education. Trial Registration: ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796 ",
doi="10.2196/29640",
url="https://www.jmir.org/2022/6/e29640",
url="http://www.ncbi.nlm.nih.gov/pubmed/35708743"
}


@Article{info:doi/10.2196/34715,
author="Suzuki, Yukio
and Sukegawa, Akiko
and Ueda, Yutaka
and Sekine, Masayuki
and Enomoto, Takayuki
and Melamed, Alexander
and Wright, D. Jason
and Miyagi, Etsuko",
title="The Effect of a Web-Based Cervical Cancer Survivor's Story on Parents' Behavior and Willingness to Consider Human Papillomavirus Vaccination for Daughters: Randomized Controlled Trial",
journal="JMIR Public Health Surveill",
year="2022",
month="May",
day="25",
volume="8",
number="5",
pages="e34715",
keywords="human papilloma virus vaccination",
keywords="vaccination",
keywords="vaccine",
keywords="vaccine hesitancy",
keywords="cancer survivor",
keywords="narrative story",
keywords="web based",
keywords="randomized controlled trial",
keywords="RCT",
keywords="HPV",
keywords="human papilloma virus",
keywords="virus",
keywords="hesitancy",
keywords="cancer",
keywords="willingness",
keywords="behavior",
keywords="parent",
abstract="Background: Providing adequate information to parents who have children eligible for human papillomavirus (HPV) vaccination is essential to overcoming vaccine hesitancy in Japan, where the government recommendation has been suspended. However, prior trials assessing the effect of brief educational tools have shown only limited effects on increasing the willingness of parents to vaccinate their daughters. Objective: The aim of this trial is to assess the effect of a cervical cancer survivor's story on the willingness of parents to get HPV vaccination for their daughters. Methods: In this double-blinded, randomized controlled trial (RCT) implemented online, we enrolled 2175 participants aged 30-59 years in March 2020 via a webpage and provided them with a questionnaire related to the following aspects: awareness regarding HPV infection and HPV vaccination, and willingness for HPV vaccination. Participants were randomly assigned (1:1) to see a short film on a cervical cancer survivor or nothing, stratified by sex (male vs female) and willingness for HPV vaccination prior to randomization (yes vs no). The primary endpoint was the rate of parents who agreed for HPV vaccination for their daughters. The secondary endpoint was the rate of parents who agreed for HPV vaccination for their daughters and the HPV vaccination rate at 3 months. The risk ratio (RR) was used to assess the interventional effect. Results: Of 2175 participants, 1266 (58.2\%) were men and 909 (41.8\%) were women. A total of 191 (8.8\%) participants were willing to consider HPV vaccination prior to randomization. Only 339 (15.6\%) participants were aware of the benefits of HPV vaccination. In contrast, 562 (25.8\%) participants were aware of the adverse events of HPV vaccination. Although only 476 (21.9\%) of the respondents displayed a willingness to vaccinate their daughters for HPV, there were 7.5\% more respondents in the intervention group with this willingness immediately after watching the short film (RR 1.41, 95\% CI 1.20-1.66). In a subanalysis, the willingness in males to vaccinate daughters was significantly higher in the intervention group (RR 1.50, 95\% CI 1.25-1.81); however, such a difference was not observed among females (RR 1.21, 95\% CI 0.88-1.66). In the follow-up survey at 3 months, 1807 (83.1\%) participants responded. Of these, 149 (8.2\%) responded that they had had their daughters receive vaccination during the 3 months, even though we could not see the effect of the intervention: 77 (7.9\%) in the intervention group and 72 (8.7\%) in the control group. Conclusions: A cervical cancer survivor's story increases immediate willingness to consider HPV vaccination, but the effect does not last for 3 months. Furthermore, this narrative approach to parents does not increase vaccination rates in children eligible for HPV vaccination. Trial Registration: UMIN Clinical Trials Registry UMIN000039273; https://tinyurl.com/bdzjp4yf ",
doi="10.2196/34715",
url="https://publichealth.jmir.org/2022/5/e34715",
url="http://www.ncbi.nlm.nih.gov/pubmed/35421848"
}


@Article{info:doi/10.2196/37480,
author="Garcia, Laura
and Birckhead, Brandon
and Krishnamurthy, Parthasarathy
and Mackey, Ian
and Sackman, Josh
and Salmasi, Vafi
and Louis, Robert
and Castro, Carina
and Maddox, Roselani
and Maddox, Todd
and Darnall, D. Beth",
title="Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial",
journal="J Med Internet Res",
year="2022",
month="May",
day="25",
volume="24",
number="5",
pages="e37480",
keywords="behavioral health",
keywords="chronic low back pain",
keywords="treatment",
keywords="virtual reality",
abstract="Background: We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective: This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods: E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results: Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Conclusions: Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID): RR2-10.2196/25291 ",
doi="10.2196/37480",
url="https://www.jmir.org/2022/5/e37480",
url="http://www.ncbi.nlm.nih.gov/pubmed/35612905"
}


@Article{info:doi/10.2196/31401,
author="Tan, Jin Rayner Kay
and Koh, Ling Wee
and Le, Daniel
and Banerjee, Sumita
and Chio, Tze-Wei Martin
and Chan, Wah Roy Kum
and Wong, Misa Christina
and Tai, Choo Bee
and Wong, Lian Mee
and Cook, R. Alex
and Chen, I-Cheng Mark
and Wong, Seong Chen",
title="Effect of a Popular Web Drama Video Series on HIV and Other Sexually Transmitted Infection Testing Among Gay, Bisexual, and Other Men Who Have Sex With Men in Singapore: Community-Based, Pragmatic, Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="May",
day="6",
volume="24",
number="5",
pages="e31401",
keywords="HIV",
keywords="STI",
keywords="testing",
keywords="health promotion",
keywords="eHealth",
keywords="mHealth",
abstract="Background: Gay, bisexual, and other men who have sex with men (GBMSM) are at disproportionately higher risk of acquiring HIV and other sexually transmitted infections (STI). While HIV/STI testing rates among GBMSM are increasing worldwide, they remain suboptimal in a variety of settings. While many studies have attempted to evaluate the efficacy of a variety of community-based campaigns, including peer and reminder-based interventions on HIV/STI testing, however few have attempted to do so for a web drama series. Objective: This study evaluates the effectiveness of a popular web drama video series developed by a community-based organization in Singapore for GBMSM on HIV and other STI testing behaviors. Methods: The study is a pragmatic, randomized controlled trial to evaluate a popular web drama video series developed by a community-based organization in Singapore for GBMSM. A total of 300 HIV-negative, GBMSM men in Singapore aged 18 to 29 years old were recruited and block-randomized into the intervention (n=150) and control arms (n=150). Primary outcomes included changes in self-reported intention to test for, actual testing for, and regularity of testing for HIV, syphilis, chlamydia or gonorrhea, while secondary outcomes include changes in a variety of other knowledge-based and psychosocial measures at the end of the study period. Results: Overall, 83.3\% (125/150) of participants in the intervention arm completed the proof of completion survey, compared to 88.7\% (133/150) in the control arm. We found improvements in self-reporting as a regular (at least yearly) tester for HIV (15.9\% difference, 95\% CI, 3.2\% to 28.6\%; P=.02), as well as chlamydia or gonorrhea (15.5\% difference, 95\% CI, 4.2\% to 26.9\%; P=.009), indicating that the intervention had positively impacted these outcomes compared to the control condition. We also found improvements in participants' intentions to test for HIV (16.6\% difference, 95\% CI, 4.3\% to 28.9\%; P=.009), syphilis (14.8\% difference, 95\% CI, 3.2\% to 26.4\%; P=.01), as well as chlamydia or gonorrhea (15.4\% difference, 95\% CI, 4.2\% to 26.6\%; P=.008), in the next 3 months, indicating that the intervention was effective in positively impacting intention for HIV and other STI testing among participants. Conclusions: There are clear benefits for promoting intentions to test regularly and prospectively on a broad scale through this intervention. This intervention also has potential to reach GBMSM who may not have access to conventional HIV and other STI prevention messaging, which have typically been implemented at sex-on-premises venues, bars, clubs, and in sexual health settings frequented by GBMSM. When coupled with community or population-wide structural interventions, the overall impact on testing will likely be significant. Trial Registration: ClinicalTrials.gov NCT04021953; https://clinicaltrials.gov/ct2/show/NCT04021953 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-033855 ",
doi="10.2196/31401",
url="https://www.jmir.org/2022/5/e31401",
url="http://www.ncbi.nlm.nih.gov/pubmed/35522470"
}


@Article{info:doi/10.2196/16141,
author="van Lieshout, Jan
and Lacroix, Joyca
and van Halteren, Aart
and Teichert, Martina",
title="Effectiveness of a Pharmacist-Led Web-Based Medication Adherence Tool With Patient-Centered Communication: Results of a Clustered Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Apr",
day="7",
volume="24",
number="4",
pages="e16141",
keywords="medication adherence",
keywords="improvement",
keywords="intervention",
keywords="web-based",
keywords="tailored intervention",
keywords="patient centered",
keywords="barriers",
keywords="primary care",
keywords="cardiovascular diseases",
keywords="diabetes",
abstract="Background: Growing numbers of people use medication for chronic conditions; nonadherence is common, leading to poor disease control. A web-based tool to identify an increased risk for nonadherence with related potential individual barriers might facilitate tailored interventions and improve adherence. Objective: This study aims to assess the effectiveness of a newly developed tool aimed at improving medication adherence. Methods: We performed a cluster randomized controlled trial in patients initiating cardiovascular or oral blood glucose--lowering medication. Participants were recruited from community pharmacies. They completed an online questionnaire comprising assessments of their risk for medication nonadherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients with high nonadherence risk in face-to-face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by pharmacists. Barriers of control patients were not presented nor discussed and these patients received usual care. The primary outcome was the effectiveness of the intervention on medication adherence at 8 months' follow-up between patients with an increased nonadherence risk from the intervention and control groups, calculated from dispensing data. Results: Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (B=--0.01; 95\% CI --0.59 to 0.57; P=.96), nor in the post hoc per-protocol analysis (B=0.19; 95\% CI --0.50 to 0.89; P=.58). Conclusions: This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effectiveness were identified. These explanations relate, for instance, to high medication adherence in the control group, study power, and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. Trial Registration: The Netherlands National Trial Register NTR5186; https://tinyurl.com/5d8w99hk ",
doi="10.2196/16141",
url="https://www.jmir.org/2022/4/e16141",
url="http://www.ncbi.nlm.nih.gov/pubmed/35389359"
}


@Article{info:doi/10.2196/29154,
author="Ghaemi, Nassir S.
and Sverdlov, Oleksandr
and van Dam, Joris
and Campellone, Timothy
and Gerwien, Robert",
title="A Smartphone-Based Intervention as an Adjunct to Standard-of-Care Treatment for Schizophrenia: Randomized Controlled Trial",
journal="JMIR Form Res",
year="2022",
month="Mar",
day="28",
volume="6",
number="3",
pages="e29154",
keywords="digital therapeutics",
keywords="schizophrenia",
keywords="smartphones",
keywords="randomized controlled trial",
keywords="mobile phone",
abstract="Background: Antipsychotic medications have limited benefits in schizophrenia, and cognitive behavioral therapy may be beneficial as an adjunct. There may be potential for implementing mobile cognitive behavioral therapy--based treatment for schizophrenia in addition to standard antipsychotic medications. Objective: This study aims to determine whether PEAR-004, a smartphone-based investigational digital therapeutic, improves the symptoms of an acute psychotic exacerbation of schizophrenia when it is added to standard treatments. Methods: This was a 12-week, multicenter, randomized, sham-controlled, rater-blinded, parallel group proof?of?concept study of 112 participants with moderate acute psychotic exacerbation in schizophrenia. This study was conducted in 6 clinical trial research sites in the United States from December 2018 to September 2019. The primary outcome, change in Positive and Negative Syndrome Scale (PANSS) from baseline to week 12 or the last available visit, was analyzed using the mixed-effects regression model for repeated measures, applied to an intent-to-treat sample. Results: The total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2-sided P=.09). The secondary scales found no benefit, except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were observed. There was some evidence of study site heterogeneity for the onboarding processes and directions on PEAR-004 product use at baseline and throughout the study. However, these differences did not affect the efficacy results. Conclusions: In the largest-to-date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate an effect on the primary outcome---total PANSS scores---when compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. This study provided many useful scientific and operational insights that can be used in the further clinical development of PEAR-004 and other investigational digital therapeutics. Trial Registration: ClinicalTrials.gov NCT03751280; https://clinicaltrials.gov/ct2/show/NCT03751280 ",
doi="10.2196/29154",
url="https://formative.jmir.org/2022/3/e29154",
url="http://www.ncbi.nlm.nih.gov/pubmed/35343910"
}


@Article{info:doi/10.2196/32213,
author="Ateudjieu, J{\'e}r{\^o}me
and Tchio-Nighie, Hirma Ketina
and Goura, Pascal Andr{\'e}
and Ndinakie, Yakum Martin
and Dieffi Tchifou, Miltiade
and Amada, Lapia
and Tsafack, Marcelin
and Kiadjieu Dieumo, Forex Frank
and Guenou, Etienne
and Nangue, Charlette
and Kenfack, Bruno",
title="Tracking Demographic Movements and Immunization Status to Improve Children's Access to Immunization: Field-Based Randomized Controlled Trial",
journal="JMIR Public Health Surveill",
year="2022",
month="Mar",
day="1",
volume="8",
number="3",
pages="e32213",
keywords="immunization status",
keywords="coverage",
keywords="completeness",
keywords="timeliness",
keywords="EPI vaccines",
keywords="children under five",
keywords="Foumban",
keywords="Cameroon",
keywords="mobile phone",
abstract="Background: Countries' Expanded Program on Immunization (EPI) contribute to the reduction of mortality and morbidity, but access to these vaccines remains limited in most low-income countries. Objective: We aim to assess whether involving community volunteers (CVs) to track children's vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children's vaccination timeliness, completeness, and coverage. Methods: This was a field-based randomized controlled trial and communities of the Foumban health district in West Cameroon were allocated to intervention or control groups. In the intervention group, a CV per community was trained to visit households monthly for a year to assess and record in a register, details of EPI-targeted children, their demographic movements and immunization status. The scanned recorded pages were sent to the health center immunization team through WhatsApp and used to organize monthly community catch-up immunization sessions. In the control group, EPI vaccination sessions were routinely conducted. Surveys were conducted at 6 and 12 months from the beginning of the intervention in both study groups to assess and compare immunization timeliness, coverage, and completeness. Results: Overall, 30 buildings per cluster were surveyed at midline and endline. Of the 633 and 729 visited households in the intervention group at midline and endline, 630 (99.5\%) and 718 (98.4\%), respectively, consented to participate. In the control group, 507 and 651 households were visited and 505 (99.6\%) and 636 (97.7\%), respectively, consented to participate. At 12 months intervention, the month one timeliness of bacille Calmette--Guerin (BCG) vaccine did not increase in the intervention group compared with the control group for the age groups 0-11 months (adjusted odds ratio [aOR] 1.1, 95\% CI 0.7-1.8) and 0-59 months (aOR 1.1, 95\% CI 0.9-1.4), and significantly increased for the first-year BCG vaccine administration for the age group 0-23 months (aOR 1.5, 95\% CI 1.1-2.2). The coverage of diphtheria-pertussis-tetanus and hepatitis B+Hemophilus influenzae type B (DPT-Hi\thinspace+Hb) dose 3 (aOR 2.0, 95\% CI 1.5-2.7) and of DPT-Hi+Hb dose 1 (aOR 1.8, 95\% CI 1.4-2.4) vaccines increased significantly in the intervention group compared with the control group in the age groups 12-59 months and 12-23 months, respectively. Specific (DPT-Hi+Hb dose 1 to DPT-Hi+Hb dose 3: aOR 1.9, 95\% CI 1.4-2.6) and general (BCG to measles: aOR 1.5, 95\% CI 1.1-2.1) vaccine completeness increased significantly in the intervention group compared with the control group. Conclusions: Findings support that involving CVs to track children's vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions improve children's vaccination timeliness, completeness, and coverage. This strategy should be adopted to improve access to vaccination for EPI target populations and the consistency verified in other contexts. Trial Registration: Pan African Clinical Trials Registry PACTR201808527428720; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3548 ",
doi="10.2196/32213",
url="https://publichealth.jmir.org/2022/3/e32213",
url="http://www.ncbi.nlm.nih.gov/pubmed/35230249"
}


@Article{info:doi/10.2196/28703,
author="Hwang, Hyunchan
and Kim, Mi Sun
and Netterstr{\o}m, Bo
and Han, Hyun Doug",
title="The Efficacy of a Smartphone-Based App on Stress Reduction: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Feb",
day="15",
volume="24",
number="2",
pages="e28703",
keywords="stress reduction",
keywords="third-wave cognitive behavioral therapy",
keywords="individual tailored treatment",
keywords="randomized controlled trial",
keywords="digital therapeutics",
abstract="Background: Stress management in the workplace is essential for a healthy mental and physical state. Due to technological advancements, individually tailored therapy and online cognitive behavioral therapy (CBT) are on the rise. Objective: This study analyzed the efficacy of a smartphone app based on third-wave CBT tailored to an individual. Methods: A randomized controlled trial was conducted with 126 participants who were divided into 2 groups. The intervention group used the smartphone app BetterLife for 10 weeks, while the control group was placed on a waiting list for the same duration. The Perceived Stress Scale--10 (PSS), Korean Utrecht Work Engagement Scale--9 (UWES), World Health Organization Quality of Life Assessment (WHOQOL), Beck Depression Inventory--II (BDI), and Beck Anxiety Inventory (BAI) were administered at baseline and after 10 weeks to both groups. Results: Of the 126 participants, 11 dropped out during the trial. A 2-way repeated measure analysis of covariance was conducted, controlling for baseline BDI. There were greater improvements in PSS (F=24.33, P<.001, $\eta$2=0.17) and UWESK scores (F=8.32, P=.0046, $\eta$2=0.06) in the intervention group than in the control group. WHOQOL scores exhibited statistically significant improvement in the intervention group in the overall quality of life (F=8.19, P=.0049, $\eta$2=0.06), physical health (F=8.87, P=.003, $\eta$2=0.07), psychological health (F=13.32, P<.001, $\eta$2=0.10), social relationships (F=19.43, P<.001, $\eta$2=0.14), and environmental domains (F=10.14, P=.002, $\eta$2=0.08) but not overall health (F=1.68, P=.20). BDI (F=7.17, P=.008, $\eta$2=0.06) and BAI (F=6.00, P=.02, $\eta$2=0.05) showed a statistically significant improvement in the intervention group, but this significance did not survive the Bonferroni correction (P<.005). Conclusions: These results provide evidence that smartphone-based CBT is a viable option for reducing stress in the workplace. Trial Registration: Clinical Research Information Service KCT0003231; https://cris.nih.go.kr/cris/search/detailSearch.do/15137 ",
doi="10.2196/28703",
url="https://www.jmir.org/2022/2/e28703",
url="http://www.ncbi.nlm.nih.gov/pubmed/35166687"
}


@Article{info:doi/10.2196/30095,
author="Mujcic, Ajla
and Blankers, Matthijs
and Boon, Brigitte
and Berman, H. Anne
and Riper, Heleen
and van Laar, Margriet
and Engels, Rutger",
title="Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Alcohol Moderation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Feb",
day="1",
volume="24",
number="2",
pages="e30095",
keywords="alcohol",
keywords="brief interventions",
keywords="cancer survivors",
keywords="effectiveness",
keywords="cost-effectiveness",
keywords="eHealth",
keywords="mobile phone",
abstract="Background: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. Objective: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors. Methods: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (?7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5\%) in the MyCourse group and 50 (48.5\%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse--Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon. Results: Alcohol use at the 6-month follow-up decreased by 38\% in the MyCourse group and by 33\% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95\% CI ?7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95\% CI ?0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US \$279 for the MyCourse group and US \$74 for the control group. The mean societal costs were US \$18,092 (SD 25,662) and US \$23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US \$ ?1158, 95\% CI ?1609 to ?781). Conclusions: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs. Trial Registration: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4206-z ",
doi="10.2196/30095",
url="https://www.jmir.org/2022/2/e30095",
url="http://www.ncbi.nlm.nih.gov/pubmed/35103605"
}


@Article{info:doi/10.2196/27696,
author="Brody, Carinne
and Chhoun, Pheak
and Tuot, Sovannary
and Fehrenbacher, E. Anne
and Moran, Alexander
and Swendeman, Dallas
and Yi, Siyan",
title="A Mobile Intervention to Link Young Female Entertainment Workers in Cambodia to Health and Gender-Based Violence Services: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2022",
month="Jan",
day="4",
volume="24",
number="1",
pages="e27696",
keywords="mHealth",
keywords="female sex workers",
keywords="HIV",
keywords="sexually transmitted infection",
keywords="linkage to services",
keywords="sexual and reproductive health",
keywords="gender-based violence",
keywords="low- and middle-income countries",
abstract="Background: Female entertainment workers (FEWs) in Cambodia experience a greater prevalence of human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), psychological distress, substance abuse, and gender-based violence (GBV) than the general female population. Reaching FEWs with health education and linking them to services has been difficult because of their hidden and stigmatized status. Objective: This study evaluated the efficacy of the Mobile Link intervention in improving FEWs' health by engaging and connecting them to existing HIV, sexual and reproductive health, and GBV services. Methods: A randomized controlled trial was conducted between March 2018 and June 2019 in the capital city and 3 other provinces in Cambodia. FEWs in the intervention arm received automated twice-weekly Short Message Service messages and voice messages with health information and direct links to outreach workers. The control group received the existing standard care, including free HIV and STI counseling and testing and a toll-free helpline staffed by trained counselors. We used a stratified random sampling method to select participants from 5 study sites in the 4 selected provinces. Initially, we randomly selected 600 participants from a list of 4000 FEWs by age group (18-24 and 25-30 years) and study site using a random number generator and enrolled them in person. The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use assessed through a face-to-face structured interview. We also measured secondary outcomes, including contact with outreach workers, escorted referral service use, forced drinking, and GBV experiences. Intervention effects were modeled using repeated measures, multilevel mixed-effects logistic regression. Results: A total of 1118 participants were recruited and enrolled in the study. We included 218 FEWs in the intervention arm and 170 FEWs in the control arm in the per protocol analyses after removing 730 dropouts. Evidence of positive intervention effects was detected for the following secondary outcomes: contacting an outreach worker (at 30 weeks: adjusted odds ratio [AOR] 3.29, 95\% CI 1.28-8.47), receiving an escorted referral (at 30 weeks: AOR 2.86, 95\% CI 1.09-7.52; at 60 weeks: AOR 8.15, 95\% CI 1.65-40.25), and never being forced to drink at work (at 60 weeks: AOR 3.95, 95\% CI 1.62-9.60). Over time, no significant differences between intervention and control groups were observed for any primary outcomes in the fully adjusted models. Conclusions: The Mobile Link intervention effectively connected FEWs with outreach workers and escorted referrals but did not show an effect on primary outcomes. Reduced forced drinking at work was also significantly more extensive in the intervention group than in the control group. Longer-term messaging may increase access to services and impact FEWs' health outcomes in the future. Trial Registration: Clinicaltrials.gov NCT03117842; https://clinicaltrials.gov/ct2/show/NCT03117842 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2614-7  ",
doi="10.2196/27696",
url="https://www.jmir.org/2022/1/e27696",
url="http://www.ncbi.nlm.nih.gov/pubmed/34982716"
}


@Article{info:doi/10.2196/29201,
author="Ben-Zeev, Dror
and Chander, Ayesha
and Tauscher, Justin
and Buck, Benjamin
and Nepal, Subigya
and Campbell, Andrew
and Doron, Guy",
title="A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE",
journal="J Med Internet Res",
year="2021",
month="Nov",
day="12",
volume="23",
number="11",
pages="e29201",
keywords="mobile health",
keywords="schizophrenia",
keywords="bipolar disorder",
keywords="depression",
keywords="mobile phone",
abstract="Background: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. Objective: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. Methods: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. Results: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2\%), major depressive disorder (136/315, 43.2\%), and schizophrenia or schizoaffective disorder (68/315, 21.6\%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment{\texttimes}time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5\% (64/154) of participants in the active group and 60.2\% (97/161) of participants in the waitlist group were retained at T2, and 33.1\% (51/154) of participants in the active group and 40.3\% (65/161) of participants in the waitlist group were retained at T3. Conclusions: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467 ",
doi="10.2196/29201",
url="https://www.jmir.org/2021/11/e29201",
url="http://www.ncbi.nlm.nih.gov/pubmed/34766913"
}


@Article{info:doi/10.2196/28322,
author="Wright, Hayley
and Martin, Faith
and Clyne, Wendy
and Clark, T. Cain C.
and Matouskova, Gabriela
and McGillion, Michael
and Turner, Andrew",
title="A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial",
journal="J Med Internet Res",
year="2021",
month="Nov",
day="5",
volume="23",
number="11",
pages="e28322",
keywords="self-management",
keywords="cancer",
keywords="survivorship",
keywords="digital",
keywords="positive psychology",
abstract="Background: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. Objective: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. Methods: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. Results: The recruitment rate was 77\% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50\% (all: 21/41, 51\%, IG: 10/21, 48\%; and CG: 11/20, 55\%). The follow-up rate (completing all questionnaires) was greater than 80\% (all: 33/41, 80\%; IG: 16/21, 76\%; and CG: 17/20, 85\%). The completion rate (attending ?3 sessions and completing all questionnaires) was greater than 60\% (all: 25/41, 61\%; IG: 13/21, 62\%; and CG: 12/20, 60\%). Engagement data showed that participants viewed between half (5.1/10, 51\%) and three-quarters (12.2/16, 76\%) of the pages in each session. Conclusions: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID): RR2-10.2196/24264 ",
doi="10.2196/28322",
url="https://www.jmir.org/2021/11/e28322",
url="http://www.ncbi.nlm.nih.gov/pubmed/34738912"
}


@Article{info:doi/10.2196/29672,
author="Ziadni, S. Maisa
and Gonzalez-Castro, Lluvia
and Anderson, Steven
and Krishnamurthy, Parthasarathy
and Darnall, D. Beth",
title="Efficacy of a Single-Session ``Empowered Relief'' Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic",
journal="J Med Internet Res",
year="2021",
month="Sep",
day="10",
volume="23",
number="9",
pages="e29672",
keywords="single-session",
keywords="empowered relief",
keywords="Zoom-delivered",
keywords="pain catastrophizing",
keywords="pain intensity",
keywords="randomized-controlled trial",
keywords="chronic pain",
abstract="Background: Cognitive behavioral therapy--pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas. Objective: The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment. Methods: We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1\%) and WLC (54/104, 51.9\%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8\% clinic patients; 83/101, 82.1\% community) who completed at least one study survey: ER (50/101, 49.5\%) and WLC (51/104, 49\%). Results: Participants (N=101) were 69.3\% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7\% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94\%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92\%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS ?8.72, 42.25\% reduction; WLC: PCS ?2.25, 11.13\% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. Conclusions: Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes that was sustained at 3 months. Web-based delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. Trial Registration: ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685 ",
doi="10.2196/29672",
url="https://www.jmir.org/2021/9/e29672",
url="http://www.ncbi.nlm.nih.gov/pubmed/34505832"
}


@Article{info:doi/10.2196/26054,
author="Wyse, Rebecca
and Delaney, Tessa
and Stacey, Fiona
and Zoetemeyer, Rachel
and Lecathelinais, Christophe
and Lamont, Hannah
and Ball, Kylie
and Campbell, Karen
and Rissel, Chris
and Attia, John
and Wiggers, John
and Yoong, Lin Sze
and Oldmeadow, Christopher
and Sutherland, Rachel
and Nathan, Nicole
and Reilly, Kathryn
and Wolfenden, Luke",
title="Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students' Web-Based Canteen Lunch Orders (Click \& Crunch): Cluster Randomized Controlled Trial",
journal="J Med Internet Res",
year="2021",
month="Sep",
day="7",
volume="23",
number="9",
pages="e26054",
keywords="nudge",
keywords="choice architecture",
keywords="intervention",
keywords="online canteen",
keywords="online ordering systems",
keywords="digital interventions",
keywords="school children",
keywords="school food service",
keywords="canteens",
keywords="menu labeling",
abstract="Background: School food outlets represent a key setting for public health nutrition intervention. The recent proliferation of web-based food ordering systems provides a unique opportunity to support healthy purchasing from schools. Embedding evidence-based choice architecture strategies within these routinely used systems provides the opportunity to impact the purchasing decisions of many users simultaneously and warrants investigation. Objective: This study aims to assess the effectiveness of a multistrategy behavioral intervention implemented via a web-based school canteen lunch ordering system in reducing the energy, saturated fat, sugar, and sodium content of primary students' web-based lunch orders. Methods: The study used a parallel-group, cohort, cluster randomized controlled trial design with 2207 students from 17 Australian primary schools. Schools with a web-based canteen lunch ordering system were randomly assigned to receive either a multistrategy behavioral intervention that included choice architecture strategies embedded in the web-based system (n=9 schools) or the standard web-based ordering system only (n=8 control schools). Automatically collected student purchasing data at baseline (term 2, 2018) and 12 months later (term 2, 2019) were used to assess trial outcomes. Primary trial outcomes included the mean energy (kJ), saturated fat (g), sugar (g), and sodium (mg) content of student lunch orders. Secondary outcomes included the proportion of all web-based lunch order items classified as everyday, occasional, and caution (based on the New South Wales Healthy School Canteen Strategy) and canteen revenue. Results: From baseline to follow-up, the intervention lunch orders had significantly lower energy content (?69.4 kJ, 95\% CI ?119.6 to ?19.1; P=.01) and saturated fat content (?0.6 g, 95\% CI ?0.9 to ?0.4; P<.001) than the control lunch orders, but they did not have significantly lower sugar or sodium content. There was also a small significant between-group difference in the percentage of energy from saturated fat (?0.9\%, 95\% CI ?1.4\% to ?0.5\%; P<.001) but not in the percentage of energy from sugar (+1.1\%, 95\% CI 0.2\% to 1.9\%; P=.02). Relative to control schools, intervention schools had significantly greater odds of having everyday items purchased (odds ratio [OR] 1.7, 95\% CI 1.5-2.0; P<.001), corresponding to a 9.8\% increase in everyday items, and lower odds of having occasional items purchased (OR 0.7, 95\% CI 0.6-0.8; P<.001), corresponding to a 7.7\% decrease in occasional items); however, there was no change in the odds of having caution (least healthy) items purchased (OR 0.8, 95\% CI 0.7-1.0; P=.05). Furthermore, there was no change in schools' revenue between groups. Conclusions: Given the evidence of small statistically significant improvements in the energy and saturated fat content, acceptability, and wide reach, this intervention has the potential to influence dietary choices at a population level, and further research is warranted to determine its impact when implemented at scale. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-030538 ",
doi="10.2196/26054",
url="https://www.jmir.org/2021/9/e26054",
url="http://www.ncbi.nlm.nih.gov/pubmed/34491207"
}


@Article{info:doi/10.2196/22229,
author="Byonanebye, Mirembe Dathan
and Nabaggala, S. Maria
and Naggirinya, Bwanika Agnes
and Lamorde, Mohammed
and Oseku, Elizabeth
and King, Rachel
and Owarwo, Noela
and Laker, Eva
and Orama, Richard
and Castelnuovo, Barbara
and Kiragga, Agnes
and Parkes-Ratanshi, Rosalind",
title="An Interactive Voice Response Software to Improve the Quality of Life of People Living With HIV in Uganda: Randomized Controlled Trial",
journal="JMIR Mhealth Uhealth",
year="2021",
month="Feb",
day="11",
volume="9",
number="2",
pages="e22229",
keywords="mHealth",
keywords="HIV",
keywords="quality of life",
keywords="interactive voice response",
keywords="mobile health",
keywords="digital health",
abstract="Background: Following the successful scale-up of antiretroviral therapy (ART), the focus is now on ensuring good quality of life (QoL) and sustained viral suppression in people living with HIV. The access to mobile technology in the most burdened countries is increasing rapidly, and therefore, mobile health (mHealth) technologies could be leveraged to improve QoL in people living with HIV. However, data on the impact of mHealth tools on the QoL in people living with HIV are limited to the evaluation of SMS text messaging; these are infeasible in high-illiteracy settings. Objective: The primary and secondary outcomes were to determine the impact of interactive voice response (IVR) technology on Medical Outcomes Study HIV QoL scores and viral suppression at 12 months, respectively. Methods: Within the Call for Life study, ART-experienced and ART-na{\"i}ve people living with HIV commencing ART were randomized (1:1 ratio) to the control (no IVR support) or intervention arm (daily adherence and pre-appointment reminders, health information tips, and option to report symptoms). The software evaluated was Call for Life Uganda, an IVR technology that is based on the Mobile Technology for Community Health open-source software. Eligibility criteria for participation included access to a phone, fluency in local languages, and provision of consent. The differences in differences (DIDs) were computed, adjusting for baseline HIV RNA and CD4. Results: Overall, 600 participants (413 female, 68.8\%) were enrolled and followed-up for 12 months. In the intervention arm of 300 participants, 298 (99.3\%) opted for IVR and 2 (0.7\%) chose SMS text messaging as the mode of receiving reminders and health tips. At 12 months, there was no overall difference in the QoL between the intervention and control arms (DID=0.0; P=.99) or HIV RNA (DID=0.01; P=.94). At 12 months, 124 of the 256 (48.4\%) active participants had picked up at least 50\% of the calls. In the active intervention participants, high users (received >75\% of reminders) had overall higher QoL compared to low users (received <25\% of reminders) (92.2 versus 87.8, P=.02). Similarly, high users also had higher QoL scores in the mental health domain (93.1 versus 86.8, P=.008) and better appointment keeping. Similarly, participants with moderate use (51\%-75\%) had better viral suppression at 12 months (80/94, 85\% versus 11/19, 58\%, P=.006). Conclusions: Overall, there was high uptake and acceptability of the IVR tool. While we found no overall difference in the QoL and viral suppression between study arms, people living with HIV with higher usage of the tool showed greater improvements in QoL, viral suppression, and appointment keeping. With the declining resources available to HIV programs and the increasing number of people living with HIV accessing ART, IVR technology could be used to support patient care. The tool may be helpful in situations where physical consultations are infeasible, including the current COVID epidemic. Trial Registration: ClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080 ",
doi="10.2196/22229",
url="https://mhealth.jmir.org/2021/2/e22229",
url="http://www.ncbi.nlm.nih.gov/pubmed/33570497"
}


@Article{info:doi/10.2196/15361,
author="Oehler, Caroline
and G{\"o}rges, Frauke
and Rogalla, Mandy
and Rummel-Kluge, Christine
and Hegerl, Ulrich",
title="Efficacy of a Guided Web-Based Self-Management Intervention for Depression or Dysthymia: Randomized Controlled Trial With a 12-Month Follow-Up Using an Active Control Condition",
journal="J Med Internet Res",
year="2020",
month="Jul",
day="14",
volume="22",
number="7",
pages="e15361",
keywords="depression",
keywords="dysthymic disorder",
keywords="randomized controlled trial",
keywords="cognitive behavioral therapy",
keywords="internet-based intervention",
keywords="active control",
keywords="iCBT",
keywords="self-management",
keywords="iFightDepression",
keywords="web-based intervention",
abstract="Background: An increasing number of studies suggest that web-based interventions for patients with depression can reduce their symptoms and are expected to fill currently existing treatment gaps. However, evidence for their efficacy has mainly been derived from comparisons with wait-list or treatment as usual controls. In particular, designs using wait-list controls are unlikely to induce hope and may even have nocebo effects, making it difficult to draw conclusions about the intervention's efficacy. Studies using active controls are rare and have not yielded conclusive results. Objective: The main objective of this study is to assess the acute and long-term antidepressant efficacy of a 6-week, guided, web-based self-management intervention building on the principles of cognitive behavioral therapy (iFightDepression tool) for patients with depression compared with web-based progressive muscle relaxation as an active control condition. Methods: A total of 348 patients with mild-to-moderate depressive symptoms or dysthymia (according to the Mini International Neuropsychiatric Interview) were recruited online and randomly assigned to 1 of the 2 intervention arms. Acute antidepressant effects after 6 weeks and long-term effects at 3-, 6-, and 12-month follow-up were studied using the Inventory of Depressive Symptomatology--self-rating as a primary outcome parameter and change in quality of life (Short Form 12) and user satisfaction (client satisfaction questionnaire) as secondary outcome parameters. Treatment effects were assessed using mixed model analyses. Results: Over the entire observation period, a greater reduction in symptoms of depression (P=.01) and a greater improvement of life quality (P<.001) was found in the intervention group compared with the active control group. Separate tests for each time point revealed significant effects on depressive symptoms at the 3-month follow-up (d=0.281; 95\% CI 0.069 to 0.493), but not after 6 weeks (main outcome:d=0.192; 95\% CI ?0.020 to 0.404) and 6 and 12 months. The intervention was significantly superior to the control condition with respect to user satisfaction (25.31 vs 21.97; t259=5.804; P<.01). Conclusions: The fact that antidepressant effects have been found for a guided self-management tool in comparison with an active control strengthens the evidence base for the efficacy of web-based interventions. The antidepressant effect became most prominent at the 3-month follow-up. After 6 weeks of intervention, significant positive effects were observed on life quality but not on depressive symptoms. Although the effect size of such web-based interventions on symptoms of depression might be smaller than that suggested by earlier studies using wait-list control conditions, they can be a cost-effective addition to antidepressants and face-to-face psychotherapy. Trial Registration: International Clinical Trials Registry Platform ICTRP080-15-09032015; https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00009323 ",
doi="10.2196/15361",
url="http://www.jmir.org/2020/7/e15361/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32673233"
}


@Article{info:doi/10.2196/14073,
author="McCarthy, L. Ona
and Aliaga, Carolina
and Torrico Palacios, Eugenia Maria
and L{\'o}pez Gallardo, Jhonny
and Huaynoca, Silvia
and Leurent, Baptiste
and Edwards, Phil
and Palmer, Melissa
and Ahamed, Irrfan
and Free, Caroline",
title="An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial",
journal="J Med Internet Res",
year="2020",
month="Jun",
day="22",
volume="22",
number="6",
pages="e14073",
keywords="Bolivia",
keywords="contraception",
keywords="mobile phone",
keywords="cellphone",
keywords="reproductive health",
keywords="young adults",
abstract="Background: Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38\% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months. Objective: This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia. Methods: This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence. Results: A total of 640 participants were enrolled, and 67.0\% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33\% control vs 37\% intervention; adjusted odds ratio [OR] 1.19, 95\% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63\% control vs 72\% intervention; adjusted OR 1.49, 95\% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8\% (6/207) reported experiencing physical violence compared with 1.9\% (4/202) in the intervention group (Fisher exact test P=.75). Conclusions: This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app. Trial Registration: ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526 ",
doi="10.2196/14073",
url="https://www.jmir.org/2020/6/e14073",
url="http://www.ncbi.nlm.nih.gov/pubmed/32568092"
}