Department of Primary Care and Mental Health, University of Liverpool, Liverpool, UK
Department of Public Health Policy and Systems, University of Liverpool, Liverpool, UK.
BMJ Open. 2024 Mar 25;14(3):e084509. doi: 10.1136/bmjopen-2024-084509.
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.
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.
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.
ISRCTN10054455.
慢性稳定性心绞痛很常见且使人虚弱。心肌梗死或血运重建术后，人们通常会接受心脏康复治疗，这对慢性稳定性心绞痛患者有帮助。然而，其在该患者群体中的常规应用的有效性和成本效益证据不足。本研究的目的是比较“激活你的心脏”心脏康复计划对慢性稳定性心绞痛患者的有效性和成本效益，与常规护理相比。
ACTIVATE 是一项多中心、平行组、两臂、优效性、实用随机对照试验，招募来自英格兰和威尔士的初级和二级保健中心，目标样本量为 518 例（1:1 分配；最小化程序分配，内置随机元素）。该研究使用安全的基于网络的分配隐匿。两种治疗方法将是最佳的常规护理（对照组）和最佳的常规护理加上“激活你的心脏”基于网络的心脏康复计划（干预组）。将进行盲法结局评估和统计分析；参与者将被解除盲法。将在基线、6 个月和 12 个月随访时进行评估。主要结局将是西雅图心绞痛问卷（SAQ-UK）的英国版本，12 个月随访时的身体受限领域。次要结局将是 SAQ-UK 的其余两个领域，呼吸困难、焦虑和抑郁、健康效用、自我效能、身体活动和递增穿梭步行试验。所有安全事件都将被记录，并评估严重不良事件，以确定它们是否与干预有关，以及是否可以预期。同时进行的经济评估将是健康服务视角的成本效益分析。嵌入式过程评估将确定解释心脏康复计划实施和影响的机制和过程。
苏格兰北部国家卫生服务研究伦理委员会批准，编号 21/NS/0115。参与者将提供书面知情同意。结果将通过同行评审的出版物传播。
ISRCTN83400414。
