Abstract
INTRODUCTION: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care.
METHODS AND ANALYSIS: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme.
ETHICS AND DISSEMINATION: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication.
TRIAL REGISTRATION NUMBER: ISRCTN10054455.
| Original language | English |
|---|---|
| Article number | e084509 |
| Number of pages | 11 |
| Journal | BMJ open |
| Volume | 14 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 25 Mar 2024 |
Bibliographical note
Funding:This work was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme, grant number 131015. It was supported by the NIHR Applied Research Collaboration North West Coast, NIHR Clinical Research Network North West Coat and NIHR Leicester Biomedical Research Centre. SJS and GYHL are NIHR Senior investigators. KJ is part funded by the NIHR Applied Research Collaboration West Midlands.
Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.
Keywords
- Humans
- Cardiac Rehabilitation/methods
- Angina, Stable
- Cost-Benefit Analysis
- State Medicine
- Internet
- Quality of Life
- Randomized Controlled Trials as Topic
- Multicenter Studies as Topic