Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial

Background Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital. Objective This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes. Methods This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change. Results We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI –0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months). Conclusions We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change. Trial Registration ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176


MS #16665
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form file:///C/Heather/Research/PCORI/Papers/CONSORT-EHEALTH%20(V%201.6.1)%20-%20Submission_Publication%20Form.html[2/12/2020 7:10: 35 PM] subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., â€oewith telephone supportâ€ ).
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., â€oefor children with Type I Diabetesâ€ ) Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "mHealth" "Nurse Coaching" "Diabetes" NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like â€oefully automatedâ € vs. â€oetherapist/nurse/care provider/physician-assistedâ€ (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This randomized control trial compared usual care to the intervention which entailed nurse health coaching and mHealth technology to track PGHD and integrate these data into the EHR.
"nurse coaching" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. faceto-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use â€oeblindedâ€ or â€oeunblindedâ€ to indicated the level of blinding instead of â€oeopenâ€ , as â€oeopenâ€ in web-based trials usually refers to â€oeopen accessâ € (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "enrolled at one of three primary care clinics" Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Diabetes education programs and group classes may be effective in the short term, but appear to be insufficient to sustain behavioral changes (e.g., improvements in physical activity and healthy eating) and self-management skills [6,74,5]. Motivational Interviewing (MI) and health coaching have the potential to customize strategies according to the individualâ€™s priorities and interests. MI is a counseling approach to build capacity to solve problems, improve self-efficacy and support behavioral change in diabetes management [8-116-9]. Health coaching utilizes MI concepts to facilitate behavior change by encouraging individuals to establish attainable personal goals, brainstorm strategies to achieve goals, and self-monitor behaviors, all within the context of an interpersonal relationship with a coach [12,1310,11]. Results of a systematic review on health coaching found improved physiological, behavioral, psychological and social outcomes in people with chronic conditions [142]. Qualitative exploration of patient perspectives on unmet needs in self-management revealed gaps in existing programs in their ability to support emotional regulation, psychological adjustment and behavior change [15]. Our group previously demonstrated the effectiveness of MI/health coaching in sustaining diabetes self-efficacy in rural communities [163]. These interventions typically rely on self-report of lifestyle changes, such as diet or physical activity modifications, limiting precision in quantifying behavioral improvements. " "We hypothesized that individuals randomized to the intervention group would show overall improved self-efficacy compared to individuals in the usual care group." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other â€oeunexpected eventsâ€ that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A detailed description of the study design was previously reported in a clinical trial protocol [273]. This was a randomized controlled trial with two arms: 1) Usual care through primary care; and 2) the Patient and Provider Engagement and Empowerment through Technology (P2E2T2) Program-nurse coaching paired with mobile sensor technology." No "Early in the intervention period, we experience an unexpected recall of the Basis PEAK activity tracking device due to a safety issue that required identifying and selecting a replacement device. The study team, in collaboration with the Advisory Boards, worked diligently and promptly to identify, test, and select a replacement (Garmin VivoSmart HR) then distribute the new device to participants in the intervention arm of the study, providing technical support to these participants as needed. This recall affected 79 participants; the vast majority of these participants received and was oriented to their new devices within 2 weeks of the recall" "Inclusion criteria were: 1) 18 years or older; 2) receiving care at one of the three clinics; 3) living with type 2 diabetes and an HbA1C of 6.5% (48 mmol/mol) or higher; and 4) able to speak English. Participants were ineligible if they did not have access to a telephone, were not able to consent due to cognitive impairment, or were pregnant." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1 2 3 4 5 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit â€oede factoâ€ eligibility criterion -this should be explicitly clarified.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
"Inclusion criteria were: 1) 18 years or older; 2) receiving care at one of the three clinics; 3) living with type 2 diabetes and an HbA1C of 6.5% (48 mmol/mol) or higher; and 4) able to speak English. Participants were ineligible if they did not have access to a telephone, were not able to consent due to cognitive impairment, or were pregnant." "We recruited participants from three suburban/urban primary care clinics within an academic health center in Northern California. " subitem not at all important essential 4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential 1 2 3 4 5 Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item â€" describe only if this may bias results) Potential participants were told that the study focused on using enabling technology to support their health in diabetes.
"Participants had an in-person orientation with the nurse coach, then telephone sessions every two weeks for 3 months (6 contacts total). The initial motivational interviewing session elicited motivations and set goals with tracking metrics to gauge progress toward goals at subsequent sessions. Throughout the sessions, coaches encouraged participants to identify facilitators and barriers to achieving their health goals." "Participants completed on-line surveys at baseline, 3-months (coinciding with the end of the intervention, or three months from baseline) and 9-months." subitem not at all important essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a â €oeConflict of interestâ€ section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
They were recruited from within the system and they made use of the MyChart electronic health record feature branded at the system. "We recruited participants from three suburban/urban primary care clinics within an academic health center in Northern California" "We used two connectors, Apple HealthKit and MyChart, to accomplish the automatic transmission of data to the EHR." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was â€oefrozenâ€ during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5-v) Ensure replicability by publishing the source code, and/or "A detailed description of the study design was previously reported in a clinical trial protocol" No "All the RN health coaches delivering the intervention completed the Health Science Institutes Registered Health Coach (RHC) and Chronic Care Professional (CCP) training program (www.healthsciences.org). A final performance evaluation using the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 global scale evaluation tool confirmed health coaching competency prior to receipt of the RHC certificate [284]. Nurses also completed a refresher course in Diabetes Management through the American Association of Diabetes Educators, as well as the standard Health System Orientation on policies, procedures, and EHR training" "Two RN researchers with nurse coaching experience in diabetes audited 5% of participant sessions and scored the coach using the MITI. They provided timely feedback to the coaches during weekly debrief sessions, reviewed scores and discussed optimization strategies by reviewing scenarios." providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained â€oeaccess to the platform and Internetâ€ [1]. To ensure access for editors/reviewers/readers, consider to provide a â€oebackdoorâ€ login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-ix) Describe use parameters
Describe use parameters (e.g., intended â€oedosesâ€ and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
"We provided a wearable tracking device (initially, Basis PEAK then Garmin VivoSmart HR) to intervention participants. This device generated real-time information about steps taken, distance walked, active minutes, heart rate and hours of sleep at night, and synced data to either an iOS mobile phone and/or iPod Touch. We provided the iPod Touch to participants who did not already possess this technology. We pre-installed MyFitnessPal, a mobile app on the devices to allow participants to log and track nutritional consumption if they chose. We provided in-person or telephone technical support to all participants â€" including usual care group participants â€" throughout the duration of the study. We encouraged participants to wear the activity tracker for the entire 9-month duration of the study." P2E2T2 Intervention Program Group. Intervention participants received the same care through their primary care clinic and training as those receiving usual care regarding health system services and resources. Additionally, the intervention included: 1) Nurse health coaching; and 2) mHealth technology to track PGHD and integrate these data into the EHR (see Figure 1). 1) Nurse health coaching. The nurse health coaches for the intervention were three registered nurses with experience in both health coaching and management of chronic disease. To promote fidelity to the intervention and a common approach to coaching participants, the nurses received core training in motivational interviewing-based coaching and diabetes management. All the RN health coaches delivering the intervention completed the Health Science Institutes Registered Health Coach (RHC) and Chronic Care Professional (CCP) training program (www.healthsciences.org). A final performance evaluation using the Motivational Interviewing Treatment Integrity (MITI) 3.1.1 global scale evaluation tool confirmed health coaching competency prior to receipt of the RHC certificate [284]. Nurses also completed a refresher course in Diabetes Management through the American Association of Diabetes Educators, as well as the standard Health System Orientation on policies, procedures, and EHR training. We paired each participant with a nurse health coach who delivered six individual sessions using a counseling style based on the concepts of Motivational Interviewing (MI). Sessions were structured to promote mutual goal setting, enhance self-efficacy in health behavior change, and assist individuals to derive meaning from data to reinforce choices and behaviors. Two RN researchers with nurse coaching experience in diabetes audited 5% of participant sessions and scored the coach using the MITI. They provided timely feedback to the coaches during weekly debrief sessions, reviewed scores and discussed optimization strategies by reviewing scenarios. Participants had an in-person orientation with the nurse coach, then telephone sessions every two weeks for 3 months (6 contacts total). The initial motivational interviewing session elicited motivations and set goals with tracking metrics to gauge progress toward goals at subsequent sessions. Throughout the sessions, coaches encouraged participants to identify facilitators and barriers to achieving their health goals.
2) mHealth technology and integration of patient-generated health data into the EHR. We provided a wearable tracking device (initially, Basis PEAK then Garmin VivoSmart HR) to intervention participants. This device generated real-time information about steps taken, distance walked, active minutes, heart rate and hours of sleep at night, and synced data to either an iOS mobile phone and/or iPod Touch. We provided the iPod Touch to participants who did not already possess this technology. We pre-installed MyFitnessPal, a mobile app on the devices to allow participants to log and track nutritional consumption if they chose. We provided in-person or telephone technical support to all participants â€" including usual care group participants â€" throughout the duration of the study. We encouraged participants to wear the activity tracker for the entire 9-month duration of the study. PGHD were integrated into the EHR when participants performed regular synchronization of the activity tracker to their personal device. We used two connectors, Apple HealthKit and MyChart, to accomplish the automatic transmission of data to the EHR. We used Synopsis, a feature within the EHR, to design a single screen page of relevant PGHD along with clinically relevant data elements (i.e. lab values, medications). In the case management module of EPIC, we designed a summary documentation form for nurse coaching sessions. We sent a final summary of goals and achievements to primary care providers. Using these tools, participants, providers, and nurse health coaches could view trends in activity levels, sleep, and nutritional intake on either their smart device or on a computer.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 5-x) Clarify the level of human involvement Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as â€oetype of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is deliveredâ€ . It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 â€" generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 â€" generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Nurse health coaching. The nurse health coaches for the intervention were three registered nurses with experience in both health coaching and management of chronic disease. To promote fidelity to the intervention and a common approach to coaching participants, the nurses received core training in motivational interviewing-based coaching and diabetes management." no subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 â€" generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i? Copy and paste relevant sections from manuscript text 6a-ii) Describe whether and how â€oeuseâ€ (including intensity of use/dosage) was defined/measured/monitored Describe whether and how â€oeuseâ€ (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional No "The most common smart goals selected by intervention participants were physical activity (103 out of 158 or 70.7%) and nutrition (37 out of 158 or 25.2%) with 7 out of 158 (4.81%) selecting other goals such as stress reduction, alcohol cessation, and improving sleep. Across all coaching sessions, participants averaged 172 minutes of nurse coaching. " "A total of 32 out of 319 (10%) participants, 6 out of 161 (3.7%) from the usual care group and 26 out of 158 (16.5%) from the intervention group, either dropped out or were lost to follow up over the course of the study." "Participants had an in-person orientation with the nurse coach, then telephone sessions every two weeks for 3 months (6 contacts total). The initial motivational interviewing session elicited motivations and set goals with tracking metrics to gauge progress toward goals at subsequent sessions. Throughout the sessions, coaches encouraged participants to identify facilitators and barriers to achieving their health goals." 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group information not in the ms, or briefly explain why the item is not applicable/relevant for your study 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study no "Our power analysis determined that with 100 participants per arm, we would have 80% power to detect differences in self-efficacy. " No 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "we used REDCap to randomize participants to one of two groups with a 1:1 ratio, stratified by clinic site, to either the usual care (control group) or the P2E2T2 program. We used a stratified block randomization to ensure a balanced number across the two groups within each site." "We used a stratified block randomization to ensure a balanced number across the two groups within each site." "we used REDCap to randomize participants to one of two groups with a 1:1 ratio 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasnâ€™t Specify who was blinded, and who wasnâ€™t. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 11a-ii) Discuss e.g., whether participants knew which intervention was the â€oeintervention of interestâ€ and which one was the â€oecomparatorâ€ Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the â€oeintervention of interestâ€ and which one was the â€oecomparatorâ€ .
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "we used REDCap to randomize randomized participants to one of two groups with a 1:1 ratio" Participants and research team members not involved in recruitment were blind to the randomization.

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Participants did not know -both groups were exposed to technology "Potential participants were told that the study focused on using enabling technology to support their health in diabetes" No "Descriptive analysis yielded means/standard deviations for continuous variables and frequencies for categorical variables. We examined distributions and collinearity to determine whether data met assumptions for planned statistical analyses. We compared demographic and health-related characteristics between the individuals in the intervention group and the usual care group using a Student's t test, Wilcoxon Signed-Rank test, chi-squared test and Fisher's exact test, as appropriate. We calculated change in outcomes over time as the difference between baseline and 3 months, and baseline and 9 months for diabetes self-efficacy scores, depression severity (PHQ-9), stress score, and PROMIS measures. We used Student's t test to compare the change in outcome between usual care and intervention groups (Significance level: p â‰¤ .05). We conducted statistical analysis using Stata v15.0 statistical software (StataCorp, College Station, Texas).
In the primary analysis, we estimated the difference over time in the effects of the intervention versus usual care in the study participants controlling for potentially relevant variables such as demographic characteristics, readiness to change, self-reported health, and comorbid disease. This was an intent to treat analysis, with the assumption that any dropouts were missing at random. In our evaluation, we did not find any significant difference between the participants who dropped out and participants who continued in the study. We adopted a mixed effects maximum likelihood model that accounts for the missing data contributed by participants who dropped out from the study. Lastly, our sensitivity analysis found no difference with regard to the significance of our findings when we excluded these participants from the analysis. We included all participants, regardless of intervention completion, in the intent to treat analysis. We used multivariate regression modeling for all hypotheses testing to estimate within-group and across-group effects of the intervention on the outcome (significance level: p â‰¤ 0.05). The mixed effects models evaluated the impact of the intervention over time on the primary outcome: Diabetes Self-Efficacy. We included a binary indicator for intervention group assignment, and a group-by-time interaction term in the models to compare improvement over time between the intervention group and usual care group. We evaluated model fit using deviance tests for nested models, the Akaike Information Criterion, and the Bayesian Information Criterion for non-nested models. We assessed the estimates for the fixed effects using a pre-determined significance level (p < 0.05) on two-sided tests and 95% confidence intervals. We used the same approach for analyzing primary and secondary outcomes analyzing the effect of the intervention at baseline, 3 and 9 months." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study X26-i) Comment on ethics committee approval Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
"This was an intent to treat analysis, with the assumption that any dropouts were missing at random. In our evaluation, we did not find any significant difference between the participants who dropped out and participants who continued in the study. We adopted a mixed effects maximum likelihood model that accounts for the missing data contributed by participants who dropped out from the study. Lastly, our sensitivity analysis found no difference with regard to the significance of our findings when we excluded these participants from the analysis. We included all participants, regardless of intervention completion, in the intent to treat analysis. " no "The study was approved by the Institutional Review Board of the institution" subitem not at all important essential subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We queried the health system EHR and diabetes registry to identify eligible participants who subsequently received mailed letters and telephone calls. Potential participants were told that the study focused on using enabling technology to support their health in diabetes. Following telephone consent, we used REDCap to randomize randomized participants to one of two groups with a 1:1 ratio, stratified by clinic site, to either the usual care (control group) or the P2E2T2 program." " The participants completed written consent during their onboarding session. "

No
Yes -Consort diagram provided in Figure 2 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 14a-i) Indicate if critical â€oesecular eventsâ€ fell into the " Figure 2 provides a CONSORT flow diagram. The diabetes registry query identified 2,242 potential participants. Of those, 1,938 were eligible for phone recruitment. We obtained verbal consent from 392 participants by phone prior to randomization. Three hundred nineteen participants attended the orientation session, completed written consent, and were included in the analysis. A total of 32 out of 319 (10%) participants, 6 out of 161 (3.7%) from the usual care group and 26 out of 158 (16.5%) from the intervention group, either dropped out or were lost to follow up over the course of the study. Of the 287 participants who completed the nine-month follow-up surveys, 155 were in the usual care group and 132 were in the intervention group. " Indicate if critical â€oesecular eventsâ€ fell into the study period, e.g., significant changes in Internet resources available or â€oechanges in computer hardware or Internet delivery resourcesâ € Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 15-i) Report demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

16-i) Report multiple â€oedenominatorsâ€ and provide definitions
Report multiple â€oedenominatorsâ€ and provide definitions: Report Nâ€™s (and effect sizes) â €oeacross a range of study participation [and use] thresholdsâ€ [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants â€oeusedâ€ the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define â€oeuseâ€ of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only â €oeusersâ€ , with the appropriate caveats that this is no longer a randomized sample (see 18-i).

See above
See Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as â€oeaverage session lengthâ€ . These must be accompanied by a technical description how a metric like a â€oesessionâ€ is defined (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This was an intent to treat analysis, with the assumption that any dropouts were missing at random. In our evaluation, we did not find any significant difference between the participants who dropped out and participants who continued in the study. We adopted a mixed effects maximum likelihood model that accounts for the missing data contributed by participants who dropped out from the study. Lastly, our sensitivity analysis found no difference with regard to the significance of our findings when we excluded these participants from the analysis. We included all participants, regardless of intervention completion, in the intent to treat analysis. " " Table 2 summarizes the descriptive results for the study outcomes. At baseline, mean diabetes self-efficacy scores were 3.66 (SD: 0.89) in the usual care group and 3.67 (SD: 0.83) in the intervention group. This score increased in both groups at three months, 3.71 (SD: 0.86) in the usual care group and 4.05 (SD: 0.69) in the intervention group. For the depression severity measure, PHQ-9, the usual care group experienced slightly greater depressive symptoms over time, while the intervention group PHQ-9 scores decreased at 3 months. There were no changes in perceived stress or the PROMIS measures. For the intervention group at baseline, average number of steps per week were 23,770 (SD: 18,470), increasing at 3 months to 39,167 (22,513), and declining at 9 months to 32,601 (19,851). Eighty-two (62%) of the 132 participants who completed the 9 month survey continued to use the device through the end of the study. " "Across all coaching sessions, participants averaged 172 minutes of nurse coaching." "Eighty-two (62%) of the 132 participants who completed the 9 month survey continued to use the device through the end of the study." 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory subitem not at all important 1 2 3 4 5 essential 19) All important harms or unintended effects in each group Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The most common smart goals selected by intervention participants were physical activity (103 out of 158 or 70.7%) and nutrition (37 out of 158 or 25.2%) with 7 out of 158 (4.81%) selecting other goals such as stress reduction, alcohol cessation, and improving sleep."

No
No Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study demonstrated short-term effectiveness of an innovative diabetes intervention using nurse health coaching and mHealth technology on diabetes self-efficacy and increased physical activity, supporting our hypothesis. However, by 6 months post-intervention, while physical activity remained above baseline, differences in self-efficacy were not sustained. " Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" "Coupling patient data with other indicators of health provides a more complete picture that could be helpful in a variety of chronic conditions, such as congestive heart failure and chronic obstructive pulmonary disease, which require a partnership between clinicians and patients for effective management. This study combined nurse coaching with mHealth and compared this intervention to usual care; future studies could include more study arms that break out the components to allow greater comparison. Future research could examine this approach in additional conditions and other strategies, such as automated feedback in the form of SMS messaging and on-line peer-support that could enhance the effectiveness of the intervention. Longer study periods with intermittent coach contact could potentially demonstrate how to sustain effects of the intervention over time. Finally, studies of implementation and dissemination across a variety of settings would improve translation of research such as this into practice. " "This study had several limitations. First, the sample might have been biased towards those readier to change and those ready to use technology, limiting generalizability. Secondly, limited generalizability of this study to other settings, due to required investments in technology, technology training and support throughout the intervention. However, we estimated the total cost of the intervention including staff time and technology to be less than $500 per participant. The total cost is a relatively small investment relative to costs of an office or emergency room visit. Finally, this intervention requires commitment to a model of care to include nurse coaches in a team-based approach. " subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION 23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the "Coupling patient data with other indicators of health provides a more complete picture that could be helpful in a variety of chronic conditions, such as congestive heart failure and chronic obstructive pulmonary disease, which require a partnership between clinicians and patients for effective management." "While traditional fee-for-service reimbursement models would not cover such interventions, managed care plans and value-based purchasing will move toward reimbursing interventions that yield quality outcomes, further enhancing the potential for sustaining interventions of this kind. Finally, because PGHD are not highly sensitive, this intervention does not have to be clinic-based. It has the potential for delivery in a variety of settings such as fitness centers, workplaces and community centers, increasing the potential to scale. " About the CONSORT EHEALTH checklist manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study As a result of using this checklist, did you make changes in your "This study was funded by the Patient Centered Outcomes Research Institute: IHS-1310-07894. This study was conceived and designed independently of the funders who have no role in data collection, analysis, or writing of manuscripts based on the data." "All authors contributed to the design of the study, interpretation of results and discussion." "The authors have no financial or non-financial competing interests to disclose."

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