Coronary disease & ACS

The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)

Am Heart JPublished Rationale and design of a registry-based cluster randomised crossover trial

Study context

Population
Patients with a recent myocardial infarction (MI)planned enrolment 1500
Planned comparison
Remote exercise-based cardiac rehabilitation (EBCR) offered as an alternative to centre-based EBCR vs centre-based EBCR only
Primary endpoint
Participation in EBCR sessions
Methodological detailsmulticentre, Each centre's intervention/control period lasts 15 months, then crossover, Key secondary aim: whether remote EBCR is at least as effective as centre-based EBCR for physical fitness and patient-reported outcomes, MACE follow-up at 1 and 3 years; serious AE monitoring; cost per quality-adjusted life-year (QALY) analysis
  • Multicentre
  • Each centre's intervention/control period lasts 15 months, then crossover
  • Key secondary aim: whether remote EBCR is at least as effective as centre-based EBCR for physical fitness and patient-reported outcomes
  • MACE follow-up at 1 and 3 years; serious AE monitoring; cost per QALY analysis

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT). Am Heart J. Published 25 April 2023. doi:10.1016/j.ahj.2023.04.014

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