Abstract
BackgroundCardiac rehabilitation (CR) programs addressing risk factor management, educational interventions, and exercise contribute to reduce mortality after myocardial infarction (MI). However, the fulfillment of guideline-recommended CR targets is currently unsatisfactory. eHealth, i.e., the use of electronic communication for healthcare, including the use of mobile smartphone applications combined with different sensors and interactive computerized programs, offers a new array of possibilities to provide clinical care. The present study aims to assess the efficacy of a web-based application (app) designed to support persons in adhering to lifestyle advice and medication as a complement to traditional CR programs for improvement of risk factors and clinical outcomes in patients with MI compared with usual care.Methods/designAn open-label multi-center randomized controlled trial is being conducted at different CR centers from three Swedish University Hospitals. The aim is to include 150 patients with MI < 75 years of age who are confident smartphone and/or Internet users. In addition to participation in CR programs according to the usual routine at each center, patients randomized to the intervention arm will receive access to the web-based app. A CR nurse reviews the patients’ self-reported data twice weekly through a medical interface at the clinic. The primary outcome of the study will be change in submaximal exercise capacity (in watts) between 2 and 4 weeks after discharge and when the patient has completed his/her exercise program at the CR center, usually around 3–6 months post-discharge. Secondary outcomes include changes in self-reported physical activity, objectively assessed physical activity by accelerometry, self-rated health, dietary, and smoking habits, body mass index, blood pressure, blood lipids, and glucose/HbA1c levels between inclusion and follow-up visits during the first year post-MI. Additionally, we will assess uptake and adherence to the application, the number of CR staff contacts, and the incidence of cardiovascular events at 1 and 3 years after the MI. Patient recruitment started in 2016, and the first study results are expected in the beginning of 2019.DiscussionThe present study will add evidence to whether electronic communication can be used to improve traditional CR programs for patients after MI.Trial registrationClinicalTrials.gov, NCT03260582. Retrospectively registered on 24 August 2017.
Highlights
Cardiac rehabilitation (CR) programs addressing risk factor management, educational interventions, and exercise contribute to reduce mortality after myocardial infarction (MI)
The hypothesis is that the intervention will enhance patient adherence to lifestyle advice and medication, resulting in better risk factor control and prognosis as well as improved self-rated health
Statistical analysis, power, and sample size Sample size calculations were based on results from a local registry (SEPHIA) data analysis including 40 post-MI patients attending CR at one of the study centers (Skåne University Hospital in Malmö)
Summary
Using the Internet and smartphones opens an array of new opportunities on how to provide care. In the latest European Society of Cardiology guidelines on prevention in clinical practice, eHealth was advocated as a promising option for providing CR, while it was pointed out that further studies in the field are needed [10]. Author details 1Heart Center and Department of Public Health and Clinical Medicine, Cardiology, Umeå University, Umeå, Sweden.
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