The Health Buddies App as a Novel Tool to Improve Adherence and Knowledge in Atrial Fibrillation Patients: A Pilot Study

Background Atrial fibrillation (AF) constitutes an important risk for stroke, especially in an ageing population. A new app (Health Buddies) was developed as a tool to improve adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in an elderly AF population by providing a virtual contract with their grandchildren, spelling out daily challenges for both. Objective The aim of this pilot study was to assess the feasibility and usability of the Health Buddies app in AF patients. Methods Two workshops were conducted to steer app development and to test a first prototype. The feasibility of the finalized app was investigated by assessing the number of eligible AF patients (based on current prescription of NOACs, the presence of grandchildren between 5 and 15 years old, availability of a mobile phone, computer, or tablet), and the proportion of those who were willing to participate. Participants had to use the app for 3 months. The motivation of the patients to use the app was assessed based on the number of logins to the app. Their perception of its usefulness was examined by specific questionnaires. Additionally, the effects on knowledge level about AF and its treatment, and adherence to NOAC intake were investigated. Results Out of 830 screened AF patients, 410 were taking NOACs and 114 were eligible for inclusion. However, only 3.7% (15/410) of the total NOAC population or 13.2% of the eligible patients (15/114) were willing to participate. The main reasons for not participating were no interest to participate in general or in the concept in particular (29/99, 29%), not feeling comfortable using technology (22/99, 22%), no interest by the grandchildren or their parents (20/99, 20%), or too busy a lifestyle (12/99, 12%). App use significantly decreased towards the end of the study period in both patients (P=.009) and grandchildren (P<.001). NOAC adherence showed a taking adherence and regimen adherence of 88.6% (SD 15.4) and 81.8% (SD 18.7), respectively. Knowledge level increased from 64.6% (SD 14.7) to 70.4% (SD 10.4) after 3 months (P=.09). The app scored positively on clarity, novelty, stimulation, and attractiveness as measured with the user experience questionnaire. Patients evaluated the educational aspect of this app as a capital gain. Conclusions Only a small proportion of the current AF population seems eligible for the innovative Health Buddies app in its current form. Although the app was positively rated by its users, a large subset of patients was not willing to participate in this study or to use the app. Efforts have to be made to expand the target group in the future.

https://docs.google.com/a/uhasselt.be/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey… 3/35 I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Anders: 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 of 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. 1 2 3 4 5 subitem not at all important essential 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 The title includes the words "application" and "tool". The used application was available for tablets and smartphones but could also be used on a personal computer. It is a multiplatform application. Therefore it was chosen to use only the word application in the title of the paper.

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").
1 2 3 4 5 subitem not at all important essential 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 This aspect is not entirely applicable for this study. The title only includes the words "adherence" and "knowledge", as these are the two main outcome parameters to which the application was directed.
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 1 2 3 4 5 The proposed study is no randomised controlled trial. It is a pilot study as mentioned in the title. subitem not at all important essential 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 The target group of this application consists of "atrial fibrillation patients" which is stated in the title.
1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

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) 1 2 3 4 5 subitem not at all important essential 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 The abstract of the paper does not explicitly mention subitem 1bi. However, the Health Buddies application was developed to improve adherence to NOACs in AF patients by providing a virtual contract with their grandchild(ren) spelling out daily challenges for both.

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) 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 Subitem 1bii is not entirely applicable to this study. Only the atrial fibrillation patients and their grandchild(ren) used the application.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. of 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 subitem not at all important essential 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 feasibility and effects of the application were assessed in different ways as indicated in the abstract: "The feasibility of the finalised app was investigated by assessing the number of eligible AF patients (based on current prescription of NOACs, the presence of grandchildren between 5 and 15 years old, availability of a smartphone, computer or tablet), and the proportion of those who were willing to participate. Participants had to use the application for three months. The motivation of the patients to use the application was assessed based on the number of logins to the app. Their perception 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) 1 2 3 4 5 subitem not at all important essential 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 for your study The problem is stated in the article as follows: "Specific data about adherenceimproving interventions in atrial fibrillation (AF) patients are very scarce and interventions were often ineffective." "However, a strict adherence to the prescribed NOAC medication regimen is of pivotal importance for optimal stroke prevention since their anticoagulant effect only lasts for 1224 hours after each intake.
[12] Coagulation monitoring for NOACs is not routinely required nor feasible for detection of nonadherence due to the short halflife of the 2a-ii) Scienti c background, rationale: What is known about the (type of) system Scienti c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci c study, from which stakeholder viewpoint is the study performed, potential impact of ndings [2]. Brie y justify the choice of the comparator.
1 2 3 4 5 subitem not at all important essential 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 The Health Buddies application is a novel tool with an innovative concept that has never been investigated before. This application was the first mHealth intervention being tested in AF patients to improve adherence to NOACs. There is a great need for new interventions as stated in the introduction as follows: "Specific data about adherenceimproving interventions in atrial fibrillation (AF) patients are very scarce and interventions were often ineffective."

2b) In INTRODUCTION: Speci c objectives or hypotheses
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 brie y explain why the item is not applicable/relevant for your study The goal of this study was described at the end of the introduction: "The aim of this pilot study was to assess the feasibility and usability of the 'Health Buddies' application in a large target group of AF patients. Additionally, the effects of the application on adherence, knowledge level about the arrhythmia and the OAC therapy and other patient reported outcomes were investigated." not in the ms, or brie y explain why the item is not applicable/relevant for your study

METHODS
The trial design is stated in the methods section as follows: "A prospective feasibility pilot study was performed with AF patients taking NOACs." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 brie y explain why the item is not applicable/relevant for your study Not applicable as there were no important changes to the methods after trial commencement.

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential 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 Not applicable for this trial. A final version of the 'Health Buddies' application was obtained after the two workshops with a focus group of atrial fibrillation patients and their grandchildren. The pilot trial was performed with one version of the 'Health Buddies' application and no content changes were performed during the trial. There were no important unexpected events and the staff that was responsible for patient recruitment remained unchanged during the entire trial.

4a) Eligibility criteria for participants
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 eligibility criteria for participants are present in the methods section and are described as follows: "Patients were considered eligible for inclusion if they met the following criteria: 1) having a documented diagnosis of AF; 2) eligibility and current prescription of NOAC therapy (i.e. dabigatran, rivaroxaban and apixaban as edoxaban was not yet approved for use); 3) having a grandchild between 5 and 15 years old; and 4) having a tablet, smartphone or computer with internet connection. Patients enrolled in other studies or nonDutch speaking patients were excluded."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
1 2 3 4 5 subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study Computer/Internet literacy was indeed an inclusion criterion which was defined in the eligibility criteria as follows: "Patients were considered eligible for inclusion if they met the following criteria: 4) having a tablet, smartphone or computer with internet connection." 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. of 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 quasianonymous 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.
1 2 3 4 5 subitem not at all important essential 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 Subitem 4aii is addressed in the methods section with the following statement: "Patients were recruited from the department of cardiology at the Jessa Hospital when they came for a consultation visit or when they were hospitalised at the cardiology ward for various reasons." 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.
1 2 3 4 5 subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study Information about recruitment and the informed consent procedure is stated as follows: "Patients were recruited from the department of cardiology at the Jessa Hospital when they came for a consultation visit or when they were hospitalised at the cardiology ward for various reasons." "The study was approved by the local ethical committee of Hasselt University and the Jessa Hospital. All participants provided written informed consent, together with the legal representative of the grandchild(ren) that participated." 4b) Settings and locations where the data were collected 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 Data were collected in different ways: "Clinical and demographical variables were obtained from patients' medical records." "The feasibility of the 'Health Buddies' application was investigated by assessing the number of AF patients that met the inclusion criteria and the proportion of eligible patients that were willing to participate. The motivation of the patients and their grandchildren to use the 'Health Buddies' application on a daily basis was investigated by followingup the frequency of application use (i.e. number of days with logins to the 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
1 2 3 4 5 subitem not at all important essential 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 Different offline questionnaires had to be completed at baseline and/or at the end of the study period: Selfreported 8item Morisky medication adherence scale (MMAS8) Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ) User Experience Questionnaire (UEQ): only at the end of the study A questionnaire gathering feedback of patients about the application: only at the end of the study 4b-ii) Report how institutional af liations are displayed Report how institutional af liations are displayed to potential participants [on ehealth media], as af liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study Affiliations of the cooperating companies and institutions were displayed to potential participants by including the affiliations' logo's on brochures, the application, the questionnaires,... However, this was only in a limited amount which probably did not bias the results.

5)
The interventions for each group with suf cient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, af liations of the developers, sponsors, and owners
Mention names, credential, af 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).
1 2 3 4 5 subitem not at all important essential 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 Subitem 5i is stated as follows in the methods section: The 'Health Buddies' application was developed by DAE Studios (Kortrijk, Belgium) in association with ipropeller (Brussels, Belgium) and the Jessa Hospital (Hasselt, Belgium), funded by a grant of Bayer SANV (Diegem, Belgium).

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.
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study As stated in the article, two workshops with a focus group of AF patients and their grandchildren were performed: "Two workshops with a focus group of AF patients and their grandchildren were organised to steer app development and to test a first prototype. The first workshop was organised to obtain input about the different elements and the concept of the 'Health Buddies' application. Various activities were organised to gain input from a focus group on all aspects of the game, including the game initiation with drafting an agreement, different content ideas (minigames, educational

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).
1 2 3 4 5 subitem not at all important essential 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 A final version of the 'Health Buddies' application was obtained after the two workshops with a focus group of atrial fibrillation patients and their grandchildren. The pilot trial was performed with this final version of the 'Health Buddies' application and no content changes were performed during the trial.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study Since the content and format of the application was developed by DAE Studios together with different other parties (ipropeller and healthcare professionals from the Jessa Hospital) and taken into account the feedback of the patients and the grandchildren during the workshops, the application was considered of good quality. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used 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.
1 2 3 4 5 subitem not at all important essential 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 Three screenshots of the application were provided in the manuscript text and the aim and content of the application were described in detail.

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.
1 2 3 4 5 subitem not at all important essential 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 Three screenshots of the 'Health Buddies' application were provided in the manuscript text as Figure 1.

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 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 For every included family (AF patient and his/her grandchild(ren)) a unique account was created. Patients and grandchildren were able to choose their own password. They did not have to pay for the application. subitem not at all important essential 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 The Health Buddies application is an innovative tool that educates, reminds, motivates and supports AF patients to be adherent for their NOAC medication. "The 'Health Buddies' application focuses on the relationship between a grandparent, diagnosed with AF, and his/her grandchild(ren) (aged 515 years old), the patient's 'health buddy'. The patient and his/her grandchild have to sign a contract at the start of the application in which they both declare to conduct a 'healthy' challenge every day ( Figure 1A). The challenge of the patient is to take his/her NOAC

5-ix) 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.
1 2 3 4 5 subitem not at all important 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 brie y explain why the item is not applicable/relevant for your study Subitem 5ix is stated as follows in the article: "The duration of the contract was set at 90 days for this pilot study and participants were supposed to use the application daily during this period."

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 21 -generalizability).
1 2 3 4 5 subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study Study participants were able to contact the study team at any time in case of technical difficulties or other problems. Additionally, as stated in the text, patients had the possibility to communicate via the 'Health Buddies' application with the healthcare professionals involved in this study and ask questions about their health. Access to registered data by the care provider was also protected with a password.

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 -generalizability).
1 2 3 4 5 subitem not at all important essential 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 As described in the paper, the application allowed the patient to manage his/her NOAC medication stock with an automated reminder when a refill was necessary. During the workshop, some patients indicated that they did not need daily reminders for taking their medication. Those who did like a reminder preferred reminders at various moments. Patients preferred to receive the reminders by text message which was integrated into the game as push notifications when the app was used on a tablet or smartphone.
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.
1 2 3 4 5 subitem not at all important essential 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 This was not applicable for this trial as the 'Health Buddies' application was a standalone intervention. 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 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 brie y explain why the item is not applicable/relevant for your study This study was a prospective feasibility pilot study. Thus, the main aim of the study was to investigate the feasibility and usability of the 'Health Buddies' application. "The feasibility of the 'Health Buddies' application was investigated by assessing the number of AF patients that met the inclusion criteria and the proportion of eligible patients that were willing to participate. The motivation of the patients and their grandchildren to use the 'Health Buddies' application on a daily basis was investigated by followingup the frequency of application use (i.e. number of days with logins to the 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]. The UEQ, JAKQ and MMAS8 questionnaires are all validated questionnaires. The references to the articles about these questionnaires can be found in the full manuscript. A final questionnaire, designed by the study team for the purpose of this study, was used to gather feedback of patients about the application. It contained questions regarding the satisfaction, usability, content and effects of the 'Health Buddies' application. The questionnaires were not completed online.
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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "The motivation of the patients and their grandchildren to use the 'Health Buddies' application on a daily basis was investigated by followingup the frequency of application use (i.e. number of days with logins to the application)." 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).

2 3 4 5
subitem not at all important essential Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Two workshops with a focus group of AF patients and their grandchildren were organised to steer app development and to test a first prototype." "At the end of the three month study period, patients had to complete the User Experience Questionnaire (UEQ) to assess their overall impression of the application and their perception of its usefulness." "A second questionnaire, designed by the study team for the purpose of this study, was used to gather feedback of patients about the application. It contained questions regarding the satisfaction, usability, 6b) Any changes to trial outcomes after the trial commenced, with reasons 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 information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were no changes to trial outcomes after the trial commenced.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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.
1 2 3 4 5 subitem not at all important essential 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 As this was a pilot study assessing the feasibility and usability of a newly developed application with an innovative concept, no sample size calculation could be performed.

7b) When applicable, explanation of any interim analyses and stopping guidelines
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 Not applicable 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 brie y explain why the item is not applicable/relevant for your study Not applicable 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 Not applicable 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 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

Not applicable
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 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 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn'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).

2 3 4 5
subitem not at all important essential 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

Not applicable
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".
1 2 3 4 5 subitem not at all important essential 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 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) 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 brie y explain why the item is not applicable/relevant for your study Not applicable 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 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 Not applicable as there were no groups that were compared. Other statistical analyses can be found in the manuscript text.
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? * 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 available data were analysed and there were no missing values.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 There were no additional analyses, such as subgroup analyses and adjusted analyses. subitem not at all important essential Does your paper address subitem X26-ii?

X26) REB/IRB Approval and Ethical Considerations
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 participants provided written informed consent, together with the legal representative of the grandchild(ren) that participated."

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) 1 2 3 4 5 subitem not at all important essential 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 The study team ensured that patients' personal data derived from this trial, were treated confidentially and anonymously.

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 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 brie y explain why the item is not applicable/relevant for your study This study was not a randomised controlled trial, but the number of screened, eligible and included patients is explained in the manuscript as follows: "Out of the 830 screened AF patients, only 114 (13.7%) were eligible for inclusion ( Figure 2). A total of 224 patients (27.0%) were not on OAC therapy and 196 (23.6%) were on VKA therapy and were therefore excluded. The remaining 410 AF patients on NOAC therapy were approached for participation in the study. However, 228 of these patients (55.6%) had no grandchildren between 5 and 15 years old; 43 13b) For each group, losses and exclusions after randomisation, together with reasons 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 The flow diagram illustrating the number of excluded patients and the proportion of eligible patients not willing to participate is presented in Figure 2 of the paper.

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 gures or tables demonstrating usage/dose/engagement.

2 3 4 5
subitem not at all important essential Does your paper address subitem 13b-i?
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 The attrition diagrams of patients and grandchildren using the application during the entire study period are presented in Figure 3 and 4.

14a) Dates de ning the periods of recruitment and followup
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 This study recruited patients between October 2015 and May 2016. The followup period per patient was three 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" 1 2 3 4 5 subitem not at all important essential 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 Critical "secular events" did not fall into the study period.
14b) Why the trial ended or was stopped (early) 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 Not applicable. The trial was not stopped early. This was a pilot study so there was no predefined number of patient inclusions.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group 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 brie y 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 issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential 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 This information is also included in Table 1.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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. There was only one study group as this was no randomised controlled trial. However, where applicable the denominators were clearly defined.

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).
1 2 3 4 5 subitem not at all important essential 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 Not applicable for this trial since it was a pilot study.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 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 brie y explain why the item is not applicable/relevant for your study Continuous variables were always reported as means ±standard deviation and categorical variables as numbers and percentages.

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).
1 2 3 4 5 subitem not at all important essential 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 Metrics of use and intensity are presented in Figure 3 and 4 and reported in the text as follows: "The frequency of application use after signing the contract differed widely among patients and grandchildren, with the proportion of days logged in to the application ranging from 0% to 99% (Figure 3). Mean percentage of days logged in was significantly higher in patients compared to grandchildren (57.7±30.0% and 24.3±23.8% respectively, P=.002). Main reasons given not to log in on a daily basis were: forgetfulness, holidays, technical problems with the app, hospital 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 brie y explain why the item is not applicable/relevant for your study This is included in the results.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speci ed from exploratory 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 brie y explain why the item is not applicable/relevant for your study There were no other analyses performed (no subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory).

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 brie y explain why the item is not applicable/relevant for your study There were no subgroup analyses of comparing only users.

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * 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 There were no important harms or unintended effects reported in the presented pilot study.

19-i) 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. "Unintended effects" also includes unintended positive effects [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 19-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, qualitative feedback from participants is reported under the subtitle: "Patient experience with the application". Please have a look at the final manuscript for a more detailed description of the feedback from patients about the 'Health Buddies' application as this section is quite comprehensive.

22)
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 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important essential 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 "The 'Health Buddies' application tries to make therapy adherence fun and stimulating for the patients. However, only 13.7% of the screened AF patients was eligible for inclusion and only 13.2% of those eligible were interested to participate. Overall, only 3.7% of the NOACtaking AF population was included in this project." "Modifications are also necessary to make the application more variate, stimulating and challenging as app use was lower than expected and decreased over time in patients but especially in the grandchildren."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential 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 brie y explain why the item is not applicable/relevant for your study "An updated version of the app can be tested in a new pilot study and/or in a larger prospective randomised controlled trial with the ultimate goal to improve health outcomes in AF patients. One can also investigate if the 'Health Buddies' concept can be applied to other chronic diseases." "Still, other and new interventions, strategies and technologies to enhance adherence to NOACs on the longterm need to be developed and investigated as AF patients are a large and diverse patient population not all having access to newer mHealth tools." 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

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.
1 2 3 4 5 subitem not at all important essential 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 "An important limitation of this study was the small number of motivated study participants, already having a good adherence and an acceptable patient knowledge. Nevertheless, the findings from this pilot project provide new insights in the development, usability and feasibility of the 'Health Buddies' application and mHealth in general for AF patients taking OAC therapy. Other possible limitations are that there were no baseline adherence data gathered with electronic monitoring before patients started using the application and that the study was performed in only one large tertiary care hospital." 21) Generalisability (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

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 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-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 https://docs.google.com/a/uhasselt.be/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formke… 32/35 not in the ms, or brie y explain why the item is not applicable/relevant for your study "It may well be that our sample group consisted of already highly motivated and adherent patients who are still eager to try new technologies and apps, and hence that adherence is lower in other patient groups." 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.
1 2 3 4 5 subitem not at all important essential 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 Not applicable for this study.

23) Registration number and name of trial registry
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 brie y explain why the item is not applicable/relevant for your study 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 As this was a pilot study, the final trial protocol has not been published in advance. The final protocol was approved by the local ethical committees. All information about this trial is as complete as possible stated in the manuscript text itself.

25)
Sources of funding and other support (such as supply of drugs), role of funders 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 "This study is part of the Limburg Clinical Research Program (LCRP) UHasseltZOLJessa, supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis OostLimburg and Jessa Hospital. The Health Buddies application was developed by DAE studios with the help of ipropeller and the Jessa Hospital Hasselt. Conception and conduction of the trial and its report were the independent and sole responsibility of the authors. Bayer SANV provided support for app development and open access publication. Permission to use the X27) Con icts of Interest (not a CONSORT item) X27-i) State the relation of the study team towards the system being evaluated 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.
1 2 3 4 5 subitem not at all important essential 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 "H.H. has been member of the scientific advisory boards and/or lecturer for BoehringerIngelheim, Bayer, BristolMyers Squibb, Pfizer, Daiichi Sankyo, and Cardiome."

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
No changes were made as all relevant aspects of the CONSORT EHEALTH checklist were already stated in the manuscript.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * Not applicable.
As a result of using this checklist, do you think your manuscript has improved? * yes no Anders: 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 yes no Anders: Any other comments or questions on CONSORT EHEALTH No STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le.
No changes were made. However, this is a valuable checklist, especially for randomised controlled trials.