Cardiac rehabilitation for people with chronic stable angina: a randomised controlled trial Acronym: Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention (ACTIVATE)

Research question Is a cardiac rehabilitation programme more effective than usual care in improving the health of people with long-standing stable angina, and is it more cost-effective? Background Angina is chest pain caused by atherosclerosis of coronary arteries, which restricts blood flow to the myocardium, especially on exertion. Current management consists of behaviour change, drug treatment and revascularisation procedures. Cardiac rehabilitation is routinely offered to patients following myocardial infarction or revascularisation procedures, but not for chronic, stable angina. Cardiac rehabilitation consists of lifestyle change, exercise training, education and mental health interventions. The National Institute for Health and Care Excellence will not support cardiac rehabilitation for chronic stable angina until stronger evidence of effectiveness and cost-effectiveness is available [1]. Objectives a) To determine the effectiveness and cost-effectiveness of a cardiac rehabilitation programme for people with chronic stable angina compared with usual care in terms of angina related health status. b) To determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme. Methods Multisite, pragmatic, parallel-group, two-armed, superiority, randomised controlled trial (RCT), with 1:1 allocation ratio, stratified by gender and recruitment site. Blinded outcome assessment and statistical analysis; unblinded participants and clinicians. Internal pilot phase. People with chronic stable angina will be mainly recruited from primary care in Liverpool, Leicester, Lancashire and North Wales. They will be randomised to receive usual care, or cardiac rehabilitation in addition to usual care. The rehabilitation is an online tailored cardiac programme called ‘ActivateYourHeart’ [2,3]. It uses behaviour change techniques such as education, goal-setting and feedback. A paper-based alternative will also be available. Outcomes will be collected at baseline, and at 6 and 12 months follow-up: Seattle Angina Questionnaire (SAQ-7) (primary) [4], Rose Dyspnea Score [5], Hospital Anxiety and Depression Scale [6], Generalised Self-Efficacy scale [7], EuroQol EQ-5D [8], Client Service Receipt Inventory [9] and physical activity with the activPAL accelerometer worn for 7 days [10,11]. Sample size of 518 to detect minimum clinically important difference of 8 points for SAQ-7 physical limitation domain, standard deviation 25 [12], 90% power, 5% significance and 20% attrition. Main analysis will be analysis of covariance at 12 months. Economic analysis will be cost-utility analysis from a health service perspective. Mixed methods process evaluation including an exploration of barriers leading to health inequities. Timelines for delivery: Develop paper-based manual (month -6 to -1). Obtaining ethical approval (month -4 to -1); trial set up (month 0 to 3); site setup (month 0 to 6); internal pilot participant recruitment (month 4 to 10); main trial participant recruitment (month 11 to 19); follow-up (month 10 to 31); process evaluation (month 8 to 31); statistical analysis, health economic analysis (month 32 to 35); writing report (month 35 to 36). Anticipated impact and dissemination: Results will be presented at scientific meetings, published in international journals, and distributed to participants, policy makers, advisory groups, professional bodies and patient support groups.