Remote Exercise SWEDEHEART Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myocardial Infarction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: CR centers will be cluster randomized and start as either the intervention or control center. Patients at intervention centers will be offered remote video exCR (first-hand option) or usual care centre-based exCR. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months and then cross-over will occur, so that intervention centers become control centers and the other way around. At intervention centers, patients participating in remote exCR will finish their 3-month exercise period, but no new patients will be offered remote exCR after the cross-over has occurred.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 79 years
- Gender
- Both males and females
Description
Due to the covid-19 pandemic, this study will be performed in two steps: 1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT). In the feasibility study, patients will be offered remote exCR at all participating sites un...
Due to the covid-19 pandemic, this study will be performed in two steps: 1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT). In the feasibility study, patients will be offered remote exCR at all participating sites until the peak of the pandemic has been achieved and care goes back to normal. We estimate that the feasibility study will include patients during 2021. The experiences from the feasibility study will guide the detailed design of the R-RCT (part 2). CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote exCR or usual care centre-based exCR, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be approximately 12-15 months (depending on results from the feasibility study). The first period will take place approximately Q1 2022 - Q2 2023, then centers cross-over from intervention to control or the other way around to the second time period Q3 2023 - Q4 2024. The recruitment will be stopped when 1500 patients are enrolled. Long-term follow-up will be performed 1 year and 3 years after the index cardiac event.
Tracking Information
- NCT #
- NCT04260958
- Collaborators
- Göteborg University
- Linkoeping University
- Uppsala University
- Investigators
- Principal Investigator: Maria Back, Ass Prof Sahlgrenska University Hospital, Sweden Study Chair: Stefan James, Prof Uppsala Clinial Research Center