The remote exercise SWEDEHEART study-Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)Show others and affiliations
2023 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 262, p. 110-118Article in journal (Refereed) Published
Abstract [en]
Background: Despite proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction (MI) participate in and complete these programs.
Study design and objectives: The Remote Exercise SWEDEHEART study is a large multicenter registry-based cluster randomized crossover clinical trial with a planned enrollment of 1500 patients with a recent MI. Patients at intervention centers will be offered supervised EBCR, either delivered remotely, center-based or as a combination of both modes, as self -preferred choice. At control centers, patients will be offered supervised center-based EBCR, only. The duration of each time period (intervention/control) for each center will be 15 months and then cross-over occurs. The primary aim is to evaluate if remotely delivered EBCR, offered as an alternative to center-based EBCR, can increase participation in EBCR sessions. The proportion completers in each group will be presented in a supportive responder analysis. The key secondary aim is to investigate if remote EBCR is as least as effective as center-based EBCR, in terms of physical fitness and patient-reported outcome measures. Follow-up of major adverse cardiovascular events (cardiovascular-and all-cause mortality, recurrent hospitalization for acute coronary syndrome, heart failure hospitalization, stroke, and coronary revascularization) will be performed at 1 and 3 years. Safety monitoring of serious adverse events will be registered, and a cost-effectiveness analysis will be conducted to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control.
Conclusions: The cluster randomized crossover clinical trial Remote Exercise SWEDEHEART study is evaluating if par-ticipation in EBCR sessions can be increased, which may contribute to health benefits both on a group level and for individual patients including a more equal access to health care.Trial registration The study is registered at
ClinicalTrials.gov (Identifier: NCT04260958) (Am Heart J 2023;262:110-118.)
Place, publisher, year, edition, pages
Elsevier BV Elsevier, 2023. Vol. 262, p. 110-118
National Category
Cardiology and Cardiovascular Disease Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:uu:diva-506406DOI: 10.1016/j.ahj.2023.04.014ISI: 000999122900001PubMedID: 37105430OAI: oai:DiVA.org:uu-506406DiVA, id: diva2:1776125
Funder
Swedish Research Council, 2018-02794Forte, Swedish Research Council for Health, Working Life and Welfare, 2019-00422Swedish Heart Lung Foundation, 202009302023-06-272023-06-272025-02-10Bibliographically approved