1. Effectiveness and cost-effectiveness of a web-based cardiac rehabilitation programme for people with chronic stable angina: protocol for the ACTIVATE (Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention) randomised controlled trial.
- Author
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Williams NH, Collins B, Comerford TJ, Dodd S, Fisher M, Hardwick B, Hennessy S, Jolly K, Jones I, Lane D, Lip GYH, Morgan E, Ralph P, Thijssen D, and Singh SJ
- Subjects
- Humans, Cost-Benefit Analysis, State Medicine, Internet, Quality of Life, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Cardiac Rehabilitation methods, Angina, Stable
- 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., Competing Interests: Competing interests: NW reports additional grants from NIHR HTA outside the submitted work and deputy chair of the NIHR HTA programme funding committee (commissioned research). DL reports additional grants from the NIHR outside the submitted work and investigator-initiated educational grants from BMS and Pfizer. DL has been a speaker for Bayer, Boehringer Ingelheim, and BMS/Pfizer and has consulted for BMS, and Boehringer Ingelheim; all outside the submitted work. GHYL has been a consultant and speaker for BMS/Pfizer, Medtronic, Boehringer Ingelheim and Daiichi-Sankyo. No fees were directly received personally. BC works part-time for Welsh Government outside of the submitted work. KJ was subcommittee chair of the NIHR Programme Grants for Applied Research until 2023. BH reports additional grants from the NIHR outside the submitted work and investigator-initiated grant from Novartis. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2024
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