The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)
(2023) In American Heart Journal 262. p.110-118- Abstract
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... (More)
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
(Less)
- author
- Bäck, Maria ; Leosdottir, Margret LU ; Ekström, Mattias ; Hambraeus, Kristina ; Ravn-Fischer, Annica ; Öberg, Birgitta ; Östlund, Ollie and James, Stefan
- organization
- publishing date
- 2023-08
- type
- Contribution to journal
- publication status
- published
- subject
- in
- American Heart Journal
- volume
- 262
- pages
- 9 pages
- publisher
- Mosby-Elsevier
- external identifiers
-
- pmid:37105430
- scopus:85158816511
- ISSN
- 0002-8703
- DOI
- 10.1016/j.ahj.2023.04.014
- language
- English
- LU publication?
- yes
- id
- ec4de7c5-5d32-441c-ad34-c0e6fcaddcf6
- date added to LUP
- 2023-08-10 10:48:18
- date last changed
- 2024-04-20 00:15:51
@article{ec4de7c5-5d32-441c-ad34-c0e6fcaddcf6,
abstract = {{<p>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</p>}},
author = {{Bäck, Maria and Leosdottir, Margret and Ekström, Mattias and Hambraeus, Kristina and Ravn-Fischer, Annica and Öberg, Birgitta and Östlund, Ollie and James, Stefan}},
issn = {{0002-8703}},
language = {{eng}},
pages = {{110--118}},
publisher = {{Mosby-Elsevier}},
series = {{American Heart Journal}},
title = {{The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)}},
url = {{http://dx.doi.org/10.1016/j.ahj.2023.04.014}},
doi = {{10.1016/j.ahj.2023.04.014}},
volume = {{262}},
year = {{2023}},
}