American heart journal · 2023
The remote exercise SWEDEHEART study-Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT).
СтатьяПоддержка исследования: вне правительства СШАПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Bäck Maria, Leosdottir Margret, Ekström Mattias, Hambraeus Kristina, Ravn-Fischer Annica, Öberg Birgitta, Östlund Ollie, James Stefan
Аннотация
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 participation 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).
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 participation 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).