Elderly Medication Adherence Intervention Using the My Interventional Drug-Eluting Stent Educational App: Multisite Randomized Feasibility Trial

Background A lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery. The largest modifiable risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy, a combination of P2Y12 inhibitors and aspirin. Objective This study aimed to determine the acceptability of a protocol and an intervention using the My Interventional Drug-Eluting Stent Educational App (MyIDEA) and to evaluate medication adherence using the proportion of days covered (PDC) and platelet activation tests in a multisite randomized controlled trial. Methods Potential participants who received a post percutaneous coronary intervention (PCI) procedure with a drug-eluting stent were approached. All patients older than 50 years and who spoke English were recruited. Participants were recruited, baseline demographics were collected, and the Hospital Anxiety and Depression Scale (HADS), Rapid Estimate of Adult Literacy in Medicine-Short Form, Burden-Benefit questionnaire, 36-Item Short Form Health Survey, and PCI knowledge questionnaire were administered. Block randomization was used to randomize participants to either usual care or MyIDEA supplementation. MyIDEA is a personalized educational intervention based on the Kolb experiential learning theory using patient narratives for education. During the visits, participants’ blood was collected to measure platelet suppression from medication. During the second and third encounters, the Morisky medication adherence score and cardiology outcomes were measured. The study was conducted at the University of Illinois Hospital and John H Stroger Jr Cook County Hospital with appropriate ethical approvals. Platelet suppression was measured through aspirin reactive units and P2Y12 reactive units. Medication adherence was measured using the PDC. The analysis team was blinded to the participants’ group membership. The primary outcome was a feasibility analysis of recruitment and retention. Results The mean age of participants was 60.4 years (SD 7.1); the majority of patients were black and non-Hispanic. The majority of patients’ reading levels were seventh grade or above, and they were not very familiar with other electronic devices for information and communication. The number of control subjects was 21, and the number of participants in the interventional arm was 24. The interventional group was able to use MyIDEA in both the hospital and outpatient setting. However, there was no significant difference in platelet suppression or medication adherence between groups. There were also differences between the groups in terms of depression and anxiety, initially, as measured by HADS. No documented adverse event associated with the intervention was found. Conclusions Elderly patients are willing to use tablet devices to be educated about health conditions. Additional studies are required to measure the effectiveness and determine the most suitable timing and location for patient education. Trial Registration ClinicalTrials.gov NCT04439864; https://clinicaltrials.gov/ct2/show/NCT04439864

I.e does the title contain the phrase "Randomized Controlled Trial"?(if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery.Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title.Avoid ambiguous terms like "online", "virtual", "interactive".Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g.email), use "computer-based" or "electronic" only if o ine products are used.Use "virtual" only in the context of "virtual reality" (3-D worlds).Use "online" only in the context of "online support groups".Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
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 brie y explain why the item is not applicable/relevant for your study A multisite feasibility trial of My Interventional Drug Eluting Stent Educational App (MyIDEA): a mobile application for elderly patients with drug-eluting  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 brie y explain why the item is not applicable/relevant for your study Your answer 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") 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 brie y explain why the item is not applicable/relevant for your study A multisite feasibility trial of My Interventional Drug Eluting Stent Educational App (MyIDEA): a mobile application for elderly patients with drug-eluting file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 10/50 subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract.If possible, also mention theories and principles used for designing the site.Keep in mind the needs of systematic reviewers and indexers by including important synonyms.(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-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 brie y explain why the item is not applicable/relevant for your study MyIDEA is a personalized educational intervention based on Kolb learning experiential theory using patient narratives for education 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 "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study The study was conducted at the University of Illinois Does your paper address subitem 1b-v?
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 brie y explain why the item is not applicable/relevant for your study Elderly patients are willing to use tablet devices to increase education about health conditions.Additional studies are required to measure the effectiveness and determining the most suitable timing and location for file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 13/50 subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program?Intended for a particular patient population?Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions?(Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-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 brie y explain why the item is not applicable/relevant for your study A lifesaving treatment for myocardial infarction is the placement of a stent in a closed or obstructed coronary artery.
[1] The placement of a stent restores circulation to areas of the heart for patients with Coronary Artery Disease (CAD).The most commonly used stent in the U.S. is a drug eluting stent (DES).
[2] Additionally, The largest modi able risk factor after receiving a stent is medication adherence to Dual AntiPlatelet Therapy (DAPT), a combination of P2Y12 inhibitors and aspirin.
[3] A seven times increased risk in death results from stopping the medication.[4-7]A range of medication nonadherence has been reported from 7% to 50%.[8,9] Even missing only 48 hours of medication has been reported to increase the risk of stent thrombosis.
[10] Current literature has shown that 5.4% of patients do not pick up their medication from the pharmacy.
[3] The most common reasons for stopping their medication were a lack of understanding and not knowing how long they would need to take the medication.[11][12][13] A review of a number of different methods have been attempted to increase medication adherence in patients post stent.[14]A pharmacy led intervention [15] was not shown to increase medication adherence.Another challenge is lower socioeconomic status has been a liated with lower health seeking behavior.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 brie y explain why the item is not applicable/relevant for your study none 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 brie y explain why the item is not applicable/relevant for your study The study was approved by the Institutional review boards (IRBs) of both institutions.The enrollment criteria included patients who 1) received a drug eluting stent during a Percutaneous Coronary Intervention (PCI) during a hospitalization for the PCI procedure, 2) were greater than 50 years old (funding agency requirement), and 3) spoke and understood English.The exclusion criteria were 1) inability to give informed consent and 2) allergy to 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.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 brie y explain why the item is not applicable/relevant for your study No computer literacy required, all approached.
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. o ine), 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 con rmation, 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 brie y explain why the item is not applicable/relevant for your study The participants were approached in person for recruitment between 4 and 24 hours after their PCI procedure and before being discharged home.

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.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 brie y explain why the item is not applicable/relevant for your study The enrollment delay was designed to allow patient recovery from the procedure that would allow for su cient awareness after the procedure and reduce potential effects of sedation on readiness to learn.

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 brie y explain why the item is not applicable/relevant for your study In the hospital and the outpatient cardiology clinic 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 brie y explain why the item is not applicable/relevant for your study See above 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 brie y explain why the item is not applicable/relevant for your study No a liations were displayed 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" 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 brie y explain why the item is not applicable/relevant for your study 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.
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 brie y explain why the item is not applicable/relevant for your study Yes, and prior paper cited for development

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 "frozen" 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 brie y explain why the item is not applicable/relevant for your study Only one version 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Screen shots previously shared

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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study See methods and prior work 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 brie y explain why the item is not applicable/relevant for your study The participant in the interventional arm had the MyIDEA program customized to their PCI procedure results.MyIDEA was a customized educational tablet with patient narratives (short stories about patients with the common reason for DAPT discontinuation) to educate them about the importance of DAPT.
[21] Full details of patient participatory design is written elsewhere.[21] .During this second research encounter, the participants interacted with the respective tablet program and completed the Morisky 8-item medication adherence questionnaire[29], the PCI knowledge questionnaire, and SF-36.
Coronary disease related outcomes such as repeat coronary intervention or myocardial infarction were determined.During this visit, another blood draw was done for the VerifyNow ARU and PRU.The interventional participants interacted with the MyIDEA app a second time and the control participants were encouraged to play games on the tablet.

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 "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered".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 21generalizability).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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study not applicable 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 brie y explain why the item is not applicable/relevant for your study For the participants randomized to the interventional arm, additional data were collected during their usage of the MyIDEA program.While using MyIDEA, participants were asked questions and their responses were recorded using the tablet microphone.The responses re ected back on participants' learning in their module and the symptoms before the procedure.Additionally, time stamps of each click or change in the program were recorded.Five patient stories were weaved throughout the program; participants were asked to record to which patient narrative they most related.
6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed ) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le 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 Your answer 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 No formal method of qualitative feedback collected but audio recording of patients responses to questions were part of the application 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 brie y explain why the item is not applicable/relevant for your study A second site was added.
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 brie y explain why the item is not applicable/relevant for your study Pilot 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 brie y explain why the item is not applicable/relevant for your study a midterm analysis was conducted but the project was not stopped.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 brie y explain why the item is not applicable/relevant for your study Upon completion of the surveys, the research participants were randomized using block randomization to either the control arm (usual care) or the interventional arm (MyIDEA supplementation).

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 brie y explain why the item is not applicable/relevant for your study Upon completion of the surveys, the research participants were randomized using block randomization to either the control arm (usual care) or the interventional arm (MyIDEA supplementation).

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 brie y explain why the item is not applicable/relevant for your study Computer generated 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 brie y explain why the item is not applicable/relevant for your study While the data was extracted and compiled, the research assistants who did not consent the participants and the PI maintained blinding of the participants.The rst 24 participants were unblinded for an intermediate evaluation.
[27] However, this current paper is a complete analysis of all 45 participants.The research team that contacted individuals for recruitment, calculated the PDC, and collected analytics were blinded.However, the nurses that consented participants, the ones who gave the participants the tablet, and the participants were unblinded.The group assignment for all participants was unblinded when the biostatistician calculated the results.11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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 brie y explain why the item is not applicable/relevant for your study Patients knew which group.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 brie y explain why the item is not applicable/relevant for your study A review of a number of different methods have been attempted to increase medication adherence in patients post stent.[14]A pharmacy led intervention [15] was not shown to increase medication adherence.Another challenge is lower socioeconomic status has been a liated with lower health seeking behavior.[16] One large area of innovation is in engaging patients in mobile health.Although currently there are over 100,000 apps to download from Google Play and the Apple Store, very few have been studied in randomized control trials.[17] As well as they are written as to high a reading grade level.[18] The strength of mobile health engagement lies in its ability to engage the individual patient via customized interventions.[19,20] file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 34/50 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study The group assignment for all participants was unblinded when the biostatistician calculated the results.The multidisciplinary team and patient advisors reviewed the results and the analysis.Descriptive statistics for outcomes and patient characteristics were calculated.Regression analysis of the VerifyNow ARU and PRU was conducted to compare the two groups.Imputation of the missing ARU and PRU was conduct via Multivariate imputation by chained.
[30] For other group comparisons, independent t test, Fisher's test, Mann-Whitney or chi square test were applied.
In order to examine the correlation between level of engagement and the time spent responding to questions in the interventional group, recordings from the participants were transcribed by (OE) and analyzed.Upon nishing transcription, each participant was labeled as engaged or unengaged.Engagement was determined using the tone of the participant's voice and the total length of recording, which could include background noise, nurses and pauses.More speci cally, tone was described as attentive or disregarding.Participant speaking time was calculated using adobe audition, isolating the voice of the participant for calculation of time.The total time the participant spent talking on MyIDEA was calculated for each visit.The average time each participant spent talking on the application was averaged across visits.In order to test for signi cance, a Mann-Whitney test was performed using a 0.05 signi cance level.

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]).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 brie y explain why the item is not applicable/relevant for your study . Imputation of the missing ARU and PRU was conduct via Multivariate imputation by chained.[30] 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 brie y explain why the item is not applicable/relevant for your study not applicable.
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 brie y explain why the item is not applicable/relevant for your study The study was approved by the Institutional review boards (IRBs) of both institutions Outline informed consent procedures e.g., if consent was obtained o ine 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.
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 brie y explain why the item is not applicable/relevant for your study Consent done in person 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 brie y explain why the item is not applicable/relevant for your study Research associate present the entire time.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 brie y explain why the item is not applicable/relevant for your study yes see gure 1 Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow 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 brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study Some loss to follow up, but intervention only targeted during hospital and outpatient clinic.
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 brie y explain why the item is not applicable/relevant for your study Only followed for 3 months 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 brie y explain why the item is not applicable/relevant for your study In this study, PDC was confounded due to the change in practice from monthly prescriptions to 3 month prescriptions for the P2Y12 inhibitors.This change increased the participants' PDC.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 brie y explain why the item is not applicable/relevant for your study All were given a chance to use, the population was quite diverse ) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group).Always clearly de ne "use" 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 brie y explain why the item is not applicable/relevant for your study See gures and tables 16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-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 brie y explain why the item is not applicable/relevant for your study Preliminary pilot not calculated for intent to treat.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 brie y explain why the item is not applicable/relevant for your study pilot 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 de nitions 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 "average session length".These must be accompanied by a technical description how a metric like a "session" is de ned (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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Adherence to DAPT is a key element to optimal prevention of negative outcomes post DES placement.MyIDEA demonstrated the feasibility of elderly patients (>50 years old) were able and willing to receive education via a tablet device.
There was not signi cant difference between the groups DAPT and PDC due to the small sample size.However, this test only measures recent medication adherence.In this study, PDC was confounded due to the change in practice from monthly prescriptions to 3 month prescriptions for the P2Y12 inhibitors.This change increased the participants' PDC.

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.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 brie y explain why the item is not applicable/relevant for your study See above

20-i) Typical limitations in ehealth trials
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 brie y explain why the item is not applicable/relevant for your study However, this test only measures recent medication adherence.In this study, PDC was confounded due to the change in practice from monthly prescriptions to 3 month prescriptions for the P2Y12 inhibitors.This change increased the participants' PDC.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 brie y explain why the item is not applicable/relevant for your study Small pilot 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study This study began before the required registry, see cover letter Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or 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 brie y explain why the item is not applicable/relevant for your study See prior papers.
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 brie y explain why the item is not applicable/relevant for your study In addition to the usual declaration of interests ( nancial 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 brie y explain why the item is not applicable/relevant for your study

None to report
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This content is neither created nor endorsed by Google.Report Abuse -Terms of Service SUBMIT Forms your paper address CONSORT item 1a? * : Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
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., "with telephone support").
) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 o ine 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 "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (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) (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 14/50 address subitem 4a-iii? interventions for each group with su cient details to allow replication, including how and when they were actually ) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota required item -describe only if this may bias results) Yes, and prior paper cited for development file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 22/50 ) Describe the history/development process file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 23/50subitem not at all important address subitem 5-iv? ) Describe use parameters Describe use parameters (e.g., intended "doses" 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.
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 prespeci ed from exploratory Does your paper address CONSORT subitem 17a? * (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 45/50 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses subitem (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial Does your paper address subitem 22-ii?
number and name of trial registry 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?
(V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 47/50 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Con icts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * This project was funded by the Department of Biomedical and Health Information Sciences and the Center of Excellence for End-of-Life Transition Research.The project described was supported by Grant Number P30AG022849 from the National Institute on Aging, Grant Number UL1 TR000050 from the National Center for Advancing Translational Sciences, and Grant P30 NR010680 from the National Institute of Nursing Research.The content is solely the responsibility of the authors and does not necessarily represent the o cial views of the National Institute on Aging, National Center for Advancing Translational Sciences, National Institute of Nursing Research or the National 8/16/2019 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 48) State the relation of the study team towards the system being evaluated Your answerHow much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 8/16/2019 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 49 Final step: Click submit !Click submit so we have your answers in our database!As a result of using this checklist, do you think your manuscript has improved?* Would you like to become involved in the CONSORT EHEALTH group?This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document Any other comments or questions on CONSORT EHEALTH Your answer 8/16/2019 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 50/50 Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.(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) Hospital and John H. Stroger Jr. Cook County Hospital 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) INTRODUCTION 2a) In INTRODUCTION: Scienti c background and explanation of rationale 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 brie y explain why the item is not applicable/relevant 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 brie y explain why the item is not applicable/relevant for your study [16]One large area of innovation is in engaging patients in mobile health.Although currently there are over 100,000 apps to download from Google Play and the Apple Store, very few have been studied in randomized control trials.[17]Aswellastheyare written as to high a reading grade level.[18]Thestrength of mobile health engagement lies in its ability to engage the individual patient via customized interventions.[Objectives: to determine the acceptability of the study and the effect of MyIDEA medication adherence through prescription days covered (PDC) and platelet activation tests in a multisite randomized control trial.MyIDEA offered immediate response to common questions after the stent procedures when the patience is at home and review medial instructions from nursing staff .file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201…15/50 file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 16/50 file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 17/50Copy 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 brie y explain why the item is not applicable/relevant for your study file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 18/50 Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used.Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
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 speci c group.If known, describe how participants obtained "access to the platform and Internet" [1].To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see 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 brie y explain why the item is not applicable/relevant for your study 8/16/2019 CONSORT-EHEALTH (V 1.6.1)-Submission/PublicationFormfile:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201…24/50Access:Allowed to share for future collaboration and development 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g.,[7, 8]for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback"[6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous[6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1].
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 -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 brie y explain why the item is not applicable/relevant for your study Not this type of intervention 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 -generalizability. For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Include privacy breaches, technical problems Include privacy breaches, technical problems.This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents."Unintendedeffects"alsoincludesunintended positive effects[2].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 brie y explain why the item is not applicable/relevant for your study Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses.This includes (if available) reasons for why people did or did not use the application as intended by the developers.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 brie y explain why the item is not applicable/relevant for your study Interpretation consistent with results, balancing bene ts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 42/50 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 43/50 CONSORT-EHEALTH (V 1.6.1)-Submission/Publication Form file:///C:/Users/boyda/Box%20Sync/Default%20Sync%20Folder/PatientKnowlegeandadherence/APHA%20paper/CONSORT-EHEALTH%20(V%201… 44/50 22)