Effect of a Lifestyle-Focused Web-Based Application on Risk Factor Management in Patients Who Have Had a Myocardial Infarction: Randomized Controlled Trial

Background Cardiac rehabilitation is central in reducing mortality and morbidity after myocardial infarction. However, the fulfillment of guideline-recommended cardiac rehabilitation targets is unsatisfactory. eHealth offers new possibilities to improve clinical care. Objective This study aims to assess the effect of a web-based application designed to support adherence to lifestyle advice and self-control of risk factors (intervention) in addition to center-based cardiac rehabilitation, compared with cardiac rehabilitation only (usual care). Methods All 150 patients participated in cardiac rehabilitation. Patients randomized to the intervention group (n=101) received access to the application for 25 weeks where information about lifestyle (eg, diet and physical activity), risk factors (eg, weight and blood pressure [BP]), and symptoms could be registered. The software provided feedback and lifestyle advice. The primary outcome was a change in submaximal exercise capacity (Watts [W]) between follow-up visits. Secondary outcomes included changes in modifiable risk factors between baseline and follow-up visits and uptake and adherence to the application. Regression analysis was used, adjusting for relevant baseline variables. Results There was a nonsignificant trend toward a larger change in exercise capacity in the intervention group (n=66) compared with the usual care group (n=40; +14.4, SD 19.0 W, vs +10.3, SD 16.1 W; P=.22). Patients in the intervention group achieved significantly larger BP reduction compared with usual care patients at 2 weeks (systolic −27.7 vs −16.4 mm Hg; P=.006) and at 6 to 10 weeks (systolic −25.3 vs −16.4 mm Hg; P=.02, and diastolic −13.4 vs −9.1 mm Hg; P=.05). A healthy diet index score improved significantly more between baseline and the 2-week follow-up in the intervention group (+2.3 vs +1.4 points; P=.05), mostly owing to an increase in the consumption of fish and fruit. At 6 to 10 weeks, 64% (14/22) versus 46% (5/11) of smokers in the intervention versus usual care groups had quit smoking, and at 12 to 14 months, the respective percentages were 55% (12/22) versus 36% (4/11). However, the number of smokers in the study was low (33/149, 21.9%), and the differences were nonsignificant. Attendance in cardiac rehabilitation was high, with 96% (96/100) of patients in the intervention group and 98% (48/49) of patients receiving usual care only attending 12- to 14-month follow-up. Uptake (logging data in the application at least once) was 86.1% (87/101). Adherence (logging data at least twice weekly) was 91% (79/87) in week 1 and 56% (49/87) in week 25. Conclusions Complementing cardiac rehabilitation with a web-based application improved BP and dietary habits during the first months after myocardial infarction. A nonsignificant tendency toward better exercise capacity and higher smoking cessation rates was observed. Although the study group was small, these positive trends support further development of eHealth in cardiac rehabilitation. Trial Registration ClinicalTrials.gov NCT03260582; https://clinicaltrials.gov/ct2/show/NCT03260582 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-018-3118-1


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 offline 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.

Clear selection
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study From title: "lifestyle-focused web-based application on risk factor management in post-myocardial infarction patients" From article: LifePod® is a web-based mobile device application. 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").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. All participants received comprehensive cardiac rehabilitation, no co-intervention was performed during the trial. subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study From title: "management in post-myocardial infarction patients" From the article: "The inclusion criteria were age 18-74 years, having suffered an MI within the last two weeks, owning a smartphone and/or having access to the internet via a computer or tablet"

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) Clear selection subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study From abstract: "All patients participated in cardiac rehabilitation and patients randomized to the intervention group received access to a web-based application for 25 weeks where information about lifestyle (i.e., diet, physical activity, smoking), risk factors (i.e., weight, blood pressure), and symptoms could be registered. The software provided feedback and lifestyle advice. "

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)

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Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In the patient interface, the patient could log information about diet, physical activity and exercise, weight, heart rate, BP, and smoking, as well as symptoms and intake of medication. The patient could compare his or her own data to guidelinerecommended targets and received automated positive feedback on healthy choices as well as general recommendations on exercise, daily physical activity, and healthy diet. In the medical interface assessed by the treating cardiac rehabilitation staff, the system ranked patients giving high priority to, for example patients reporting chest pain or out-of-range BP measurements. The medical interface was reviewed by a nurse twice weekly. " 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. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "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)

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Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligibility screening and inclusion was performed in-hospital within two weeks of the index MI while participants were admitted in a coronary care unit. " 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) Clear selection Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We recruited 150 patients (81% men, 60.4±8.8 years). " "Uptake (logging data in the application at least once) was 86%. Adherence (logging data at least twice per week) was 92% in week 1 and 57% in week 25." 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The web-based application in our study did not speci cally give feed-back on adherence to the exCR programme, but rather to increase physical activity levels in general, which may explain the lack of signi cant differences in exercise capacity between groups." "In our study, while uptake was high, adherence to the web-based application declined over time with just over half of the users logging data at least twice weekly at the end of the 25-week intervention period. Reported reasons for stopping use of the web-based application were mostly related to stress, some experienced a lack of feedback and some experienced too much feedback. User attrition in eHealth studies is a well-known methodological challenge, with attrition rates reaching 60-80%. High attrition rates can make it di cult to measure an intervention's effect and subsequently threaten both internal-and external study validity "

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 stand-alone 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) Clear selection

Clear selection
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Previous studies on eHealth in cardiac rehabilitation have resulted in noninferiority or concluded that patients bene tted with regards to lifestyle changes and risk factor management. These studies have, however, varied in sample size and follow-up time and more studies are needed before eHealth can be implemented in routine healthcare. eHealth is of interest to the eld of cardiac rehabilitation since it has the potential to overcome some known barriers, for example, geographical distance, communication barriers and rigid follow-up structures." 2b) In INTRODUCTION: Specific objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The aim of this study was to evaluate the e cacy of a web-based application as an addition to a comprehensive centre-based cardiac rehabilitation programme, in comparison to usual care centre-based cardiac rehabilitation, only. The web-based application was designed to support adherence to lifestyle advice and self-control of risk factors in patients who had recently suffered an MI. In the planning phase of our study, we predicted that the web-based application would primarily have the potential to affect patient's lifestyle. ExCR is a pivotal part of comprehensive cardiac rehabilitation and has been shown to decrease cardiovascular mortality and rehospitalisation in patients with CHD in multiple studies. Since the bene ts of exCR are largely mediated through an increase in physical tness submaximal exercise capacity, an objective measurement of physical tness, was chosen as the primary outcome. " 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted an unblinded parallel multicentre randomized controlled trial (RCT) at three cardiac rehabilitation centres based at university hospitals in Sweden. " "With a power of 90%, a two-sided signi cance level of 0.05, and a least mean difference at 10 Watts (W) (standard deviation (SD) ± 20 W) between groups, the estimated sample size needed was 50 patients in each group (22). However, expected loss of adherence to the web-based application led to the formation of an unequal allocation ratio of 1:2 in the usual care and intervention groups. " Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, no changes were made to methods after trial commencement.

Clear selection
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, no changes were made to the web-based application after trial commencement.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "having suffered an MI within the last two weeks"

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

Clear selection
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Inclusion criteria: "owning a smartphone and/or having access to the internet via a computer or tablet, and being able to handle the software. " and exclusion criteria: ", inability to speak or understand Swedish" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligibility screening and inclusion was performed in-hospital within two weeks of the index MI while participants were admitted in a coronary care unit " "Participants in both arms of the study were offered participation in a comprehensive cardiac rehabilitation programme at each centre. " "In short, the CR programmes consisted of a minimum of ve out-patient follow-up visits post-discharge ( Figure 1); three visits with a nurse or physician and two visits with a physiotherapist. "

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.

Clear selection
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Local study coordinators (physicians, nurses, or physiotherapists) provided eligible patients with information about the study, offered participation and obtained a written informed consent. " 4b) Settings and locations where the data were collected subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...at three cardiac rehabilitation centres based at university hospitals in Sweden. At the time of the study approximately 1200 patients < 75 years of age were treated for acute MI at the three study centres each year."

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. Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. "In the patient interface, the patient could log information about diet, physical activity and exercise, weight, heart rate, BP, and smoking, as well as symptoms and intake of medication. " However, outcome data were from a national quality registry: "The cardiac rehabilitation centres registered follow-up patient data in the SWEDEHEART registry, a nationwide registry that records baseline characteristics, treatments, follow-up and outcome data of patients after suffering an MI. Data collection started at the time of index MI and continued at all follow-up visits shown in Figure 1. The time points for data collection were prespeci ed in accordance with standardized SWEDEHEART registry follow-up visits. Information was collected using standardized forms which can be downloaded from the SWEDEAHEART registry´s web-page. "

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results)

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Clear selection
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was partially sponsored by Cross Technology Solutions AB. The funding party had no role in design of the study, analysis of data or writing of the manuscript. The authors declare that they have no competing interests."

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. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study From the study protocol: "We performed a non-randomized feasibility study to test the LifePod® application as a partial alternative to standard care, by recruiting 50 patients between September 2013 and January 2015. Results showed that 35% of the screened patients were included in the study."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "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).

Clear selection
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, no changes were made to the application 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.

Clear selection
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In our study we used data collected through standardized protocols from the SWEDEHEART registry. The registry is well-established in Swedish cardiac rehabilitation centres and is used daily by personnel. The SWEDEHEART registry's nationwide coverage is >75%, registering eligible cases from 97% of Swedish hospitals. Data quality is monitored, showing >95% agreement with data from hospital records. Using SWEDEHEARTs prespeci ed time-points for follow-up and procedures provided a standardization which otherwise can be a challenge in multicentre trials. Cardiac rehabilitation programme attendance was high, and few participants were lost on follow-up." -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Clear selection
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable since outcome data was derived from a national registry.

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "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).

Clear selection
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants randomized to the intervention group of the study received access to the LifePod® support software for the rst 25 weeks of the cardiac rehabilitation programme"

Clear selection
Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "LifePod® is a web-based mobile device application designed to support adherence to lifestyle advice and self-control of risk factors. " "The patient could compare his or her own data to guideline-recommended targets and received automated positive feedback on healthy choices as well as general recommendations on exercise, daily physical activity, and healthy diet. "

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. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In the patient interface, the patient could log information about diet, physical activity and exercise, weight, heart rate, BP, and smoking, as well as symptoms and intake of medication." Participant were free to use the application how many times they liked, no information was obligatory to log.

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). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?

Clear selection
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In the medical interface assessed by the treating cardiac rehabilitation staff, the system ranked patients giving high priority to, for example patients reporting chest pain or out-of-range BP measurements. The medical interface was reviewed by a nurse twice weekly. " "Data collection started at the time of index MI and continued at all follow-up visits shown in Figure 1. The time points for data collection were prespeci ed in accordance with standardized SWEDEHEART registry follow-up visits. Information was collected using standardized forms which can be downloaded from the SWEDEAHEART registry´s web-page. " "At the physiotherapist visits at 2-4-weeks and 4-6-months, a symptom-limited exercise test on a bicycle ergometer was performed" "Three follow-up visits with a nurse and/or physician at approximately 2-weeks, at 6-10-weeks and at 12-14-months focused on risk factors and lifestyle."

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). Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The patient "received automated positive feedback on healthy choices as well as general recommendations on exercise, daily physical activity, and healthy diet." the feedback was in the application and via text messages.

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.

Clear selection
Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, no co-intervention was performed during the trial.
Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The primary outcome was change in submaximal exercise capacity (W) measured at the two consecutive submaximal exercise tests. Secondary outcomes were changes in smoking status, dietary habits, and physical activity, as well as SBP and diastolic BP (DBP), total-, LDL-and HDL-cholesterol, triglycerides, fasting plasmaglucose and HbA1c, and BMI. Secondary outcomes also included uptake and adherence to the web-based application. " Primary outcomes; "At the physiotherapist visits at 2-4-weeks and 4-6-months, a symptom-limited exercise test on a bicycle ergometer was performed. During the test, heart rate, systolic blood pressure (SBP), perceived exertion, dyspnoea and chest pain were registered according to Borg´s perceived exertion (RPE) and Category Ratio (CR-10) scales. The test was discontinued at Borg RPE 17, dyspnoea 7 on Borg´s CR-10 scale, or other routine discontinuation criteria for exercise stress testing including e.g., chest pain and fall in SPB. " Secondary outcomes: "Three follow-up visits with a nurse and/or physician at approximately 2-weeks, at 6-10-weeks and at 12-14-months focused on risk factors and lifestyle. Fasting plasma-glucose (mmol/L), haemoglobin A1c (HbA1c) (mmol/mol) and plasma-lipids (total-, LDL-, high-density lipoprotein (HDL)cholesterol and triglycerides) (mmol/L) samples were analysed with accredited methods at each hospital. BP was measured with a manual sphygmomanometer after a 5-min rest with patient in sitting position. Weight was measured in light indoor clothing and body mass index (BMI) was calculated. Smoking cessation was self-reported. At baseline, 6-10 weeks and 12-14 months tobacco abstinence was de ned as being smoke-free for ≥1 month. At the 2-week visit abstinence was de ned as being abstinent at the time of the visit. Diet was evaluated using a simple four-item questionnaire, adapted from national guidelines for management of unhealthy lifestyle in the general population. The questions aimed to quantify the consumed amount of vegetables, fruit, sh, and sweets. Each question had four possible answers giving zero to three points. The scores for each question were subsequently added, forming a healthy diet index (0-12 points). Self-reported physical activity was evaluated using two sets of questionnaires: "Haskell's questions on physical activity and exercise ", that evaluates number of days performing at least 30 minute of physical activity and at least 20 minute of exercise training during the latest week; and "Frändin/Grimby physical activity questionnaire" aimed to evaluate the level of physical activity a person achieved in the last week. The Frändin/Grimby scale is numerical from one to six, one being hardly any physical activity and six being regular strenuous physical activity."

Clear selection
Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
Not applicable, no online questionnaire was used to collect outcome data.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?

Clear selection
Copy and paste relevant sections from manuscript text "Uptake was de ned as proportion of patients who log on to the patient interface at least once and adherence was de ned as proportion of patients registering data at least twice per week on a weekly basis throughout the 25-week intervention period. What participants logged was monitored "The most reported parameter was intake of medication and consumption of vegetables, followed by physical activity (Figure   7)."

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).

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Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text It was though interviews: "Reported reasons for stopping use of the web-based application were mostly related to stress, some experienced a lack of feedback and some experienced too much feedback" 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 briefly explain why the item is not applicable/relevant for your study No changes were made to trial outcomes after trial commenced.

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.

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...expected loss of adherence to the web-based application led to the formation of an unequal allocation ratio of 1:2 in the usual care and intervention groups." 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Once included in the study, the participants were randomized to one of two study arms using opaque sealed envelopes. The envelopes, that included information on which study group the participant would be randomized to, were prepared by a member of the research team, and subsequently mixed by another member.
Envelopes were thereafter sequentially numbered with unique numbers for each recruiting site. " Care providers were not randomized.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Central randomization was performed.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2… 38/61 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Once included in the study, the participants were randomized to one of two study arms using opaque sealed envelopes. The envelopes, that included information on which study group the participant would be randomized to, were prepared by a member of the research team, and subsequently mixed by another member. Envelopes were thereafter sequentially numbered with unique numbers for each recruiting site. " Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Local study coordinators (physicians, nurses, or physiotherapists) provided eligible patients with information about the study, offered participation and obtained a written informed consent." Afterwhich patients were randomized using above mentioned envelopes by the local study coordinators. "Upon recruitment, baseline questionnaires were administered." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who 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).

Clear selection
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Our study was an unblinded study.
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".
Clear selection 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Eligible participants received information on the study and that the aim was to evaluate a web-based application that they would receive access to or not.
"All patients participated in cardiac rehabilitation and patients randomized to the intervention group received access to a web-based application for 25 " Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. No sham intervention was used. Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "To compare outcome measures between the groups for continuous variables, independent Student´s-T test and Mann-Whitney test (unadjusted)." "To minimize the confounding effect of any differences between the groups at baseline, delta values were calculated for continuous variables between baseline and follow-up, and between the rst and second physiotherapist follow-up visits. "

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]).

Clear selection
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 briefly explain why the item is not applicable/relevant for your study "Data were analysed on an intention-to-treat basis. Individuals with missing data on covariates or outcome variables were excluded from the analysis (listwise Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "..univariate ANOVA were used, adjusting for age, gender, weight, previous heart disease and smoking status at index event. In the ANOVA the dependent variable were the measured outcomes, and the independent variable were the intervention and chosen covariates"

Clear selection
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study protocol, which followed the principles outlines in the Declaration of Helsinki, was approved by the Regional Ethical Review Board at Lund University (approval number: 2016/5)."

Clear selection
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Written consent was obtained in person by local study coordinators. ..."obtained a written informed consent"

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Forty-nine patients were allocated to the control group and 101 to the intervention group." "Attendance in cardiac rehabilitation was generally high. Ninety-three percent (n=92) of patients in the intervention group attended the rst physiotherapist follow-up visit and 72% (n=71) attended the second. The corresponding percentages for the usual care group were 100% (n=48) and 88% (n=42). During these visits 69% ( Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Because of missing data at rst or second physiotherapy follow-up, only 40 participants in the usual care group and 66 in the intervention group quali ed for analyses of the primary outcome. " "Reasons for non-completion are not documented in the SWEDEHEART registry, but according to clinical experience reasons often include common cold, leg or joint pain and perceived inability to exercise. "

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Clear selection
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " Figure 6. Percentage of participant logging data to the web-based application at least twice weekly." 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patient inclusion started in April 2016 and was nalised in April 2018. The followup period was completed in June 2019." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

Clear selection
Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. No secular events were reported during the trial period.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable. The trial was not stopped early.

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.

Clear selection
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Age, gender and previous diseases were reported. Computer/Internet/ehealth illiteracy was an exclusion criterion in our trial. 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

Clear selection
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Because of missing data at rst or second physiotherapy follow-up, only 40 participants in the usual care group and 66 in the intervention group quali ed for analyses of the primary outcome. "

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).
Clear selection 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 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 briefly explain why the item is not applicable/relevant for your study "Data were analysed on an intention-to-treat basis." Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For all analyses, an alpha level of .05 and 2-tailed testing was used."

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable, we do not report effect size. When reporting binary outcomes, numbers and percentages are reported.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "An additional analysis was made on mortality and number of hospitalreadmissions during the trial period."

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).

Clear selection
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No, user-only analysis was not performed.
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 briefly explain why the item is not applicable/relevant for your study No harms or unintended effects were reported during the trial. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Reported reasons for stopping use of the web-based application were mostly related to stress, some experienced a lack of feedback and some experienced too much feedback." 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). Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In our study, evaluating the effects of a web-based application as an addition to usual care as compared to usual care alone, there was a trend towards better exercise capacity in the intervention group, however not statistically signi cant. On the other hand, the patients receiving access to the web-based application had a signi cantly reduced SBP at the rst two follow-ups, a reduced DBP at the second follow-up and an initial increase in intake of sh and fruit. While attendance in cardiac rehabilitation was high in both groups, adherence to the web-based application declined over time."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Clear selection
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our results add to existing evidence and suggest that complementing comprehensive cardiac rehabilitation programmes with a web-based application may positively affect patients' risk factor outcomes and lifestyle, including blood pressure and dietary choices. Additionally, web-based technologies might be used to make cardiac rehabilitation programmes more exible and individualized, but further efforts should be invested to nd ways to improve patient adherence to the platforms."

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.

Clear selection
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our study was unblinded. Although blinded RCT is preferred in validating treatments, it is di cult to blind patients to eHealth interventions. The follow-up data does not include information on the use of commercial web-based applications by the patients in the control group."

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

Clear selection
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 not in the ms, or briefly explain why the item is not applicable/relevant for your study The results were discussed and compared to previous studies to give context and generalizability. E.g.
"This indicates that patient characteristics is one possible determining factor for whether technology-based cardiac rehabilitation can be successful." "This indicates that even if technology-based cardiac rehabilitation aims to make traditional programmes more exible and individualized even the technology platforms need to be adjusted to individual need for optimum effect." "The age limit employed in the study may restrict generalizability to all age groups." 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.

Clear selection
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In our study all participants received comprehensive cardiac rehabilitation which is the routine setting.
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study ClinicalTrials.gov, NCT03260582. Retrospectively registered on 24 August 2017. In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Clear selection
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The authors declare that they have no competing interests." As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
Completing the list of funding.