Effect of a lifestyle-focused web-based application on risk factor management in post-myocardial infarction patients: a randomized controlled trial (Preprint)

BACKGROUND Comprehensive cardiac rehabilitation (CR) is central in reducing mortality and morbidity after myocardial infarction (MI). However, fulfilment of guideline recommended CR targets is currently unsatisfactory. eHealth offers new possibilities to improve clinical care. OBJECTIVE The aim of this study was to assess the effect of a web-based application designed to support adherence to lifestyle advice and self-control of risk factors, in addition to usual care centre-based CR, compared with usual care CR, only. METHODS In this unblinded multi-centre randomized controlled trial, we included 150 post-MI patients (81% men, 60.4±8.8 years) who participated in a CR programme. In addition to usual care, patients randomized to the intervention received access to a web-based application for 25 weeks where information about lifestyle, risk factors, and symptoms could be registered. The software provided feedback and lifestyle advice. The primary outcome was change in submaximal exercise capacity (W) between follow-up visits at 2-weeks and 4-months post-MI. Secondary outcomes included changes in lifestyle and modifiable risk factors between baseline and 2-weeks, 2-months and 1-year follow-up visits, and uptake and adherence to the web-based application. Regression analysis was used, adjusting for relevant baseline variables. RESULTS There was a numerical trend toward better exercise capacity in the intervention group compared to the usual care group (+14.4±19.0 vs. +10.3±16.1 W) although the difference was non-significant (P=.22). Intervention patients achieved significantly larger blood pressure reduction compared to those receiving usual care at 2-weeks (systolic -27.7 vs. -16.4 mmHg, P =.006) and at 2-months (systolic -25.3 vs. -16.4 mmHg, P=.02, and diastolic -13.4 vs -9.1, P =.05). The healthy diet index score improved significantly between baseline and the 2-week follow-up in the intervention group (2.3 vs. 1.4 points, P =.05), mostly due to an increase in the consumption of fish and fruit. At 2-months, 70% vs. 46% of smokers in the intervention vs. usual care groups had quit smoking, and at 1-year the respective percentages were 57% vs. 36%. The number of smokers in the study was however low (n=33) and the differences non-significant. No differences were observed in other secondary endpoints. Attendance in CR was high, with 97% of patients in the intervention group and 100% of patients receiving usual care only attending 1-year follow-up. Uptake, defined as logging data in the application at least once, was 86%. Adherence, defined as logging data at least twice per week, was 92% in week 1 and 57% in week 25. CONCLUSIONS Complementing CR with a web-based application improved blood pressure and healthy food habits during the first months after MI, and a non-significant tendency towards better exercise capacity and higher smoking cessation rates were observed. Although derived from a small study group, these positive trends support further development of eHealth in CR. CLINICALTRIAL ClinicalTrials.gov, NCT03260582. Retrospectively registered on 24 August 2017. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-3118-1