Title: Cardiac rehabilitation for people with chronic stable angina: a randomised controlled trial_x000D_ _x000D_ Acronym: Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention (ACTIVATE)
Funder: Department of Health and Social Care

Abstract: Aims of the research_x000D_ The aims of the project are to improve the health of people with long-term angina chest pain, that is not getting worse and does not require an operation, but which still limits daily activities. We aim to assess whether a rehabilitation programme is more effective than usual care in improving the health of people with long-standing stable angina, whether the programme is good value for money, and whether it is delivered as intended._x000D_ _x000D_ Background to the research_x000D_ Angina is chest pain brought on by physical exertion or stress and is caused by narrowed blood vessels restricting the flow of blood to the heart muscle. It can severely limit day to day activities. Cardiac rehabilitation programmes promote the physical and mental health of people with heart disease by increasing their understanding of the disease and improving their physical fitness levels. Cardiac rehabilitation is routinely recommended after heart attacks or heart surgery, but not for those people with stable angina who do not require an operation. Although it is likely that cardiac rehabilitation could also benefit people with stable angina, more evidence is needed before it can be recommended._x000D_ _x000D_ Design and methods used_x000D_ We will recruit people with long-term stable angina and divide them into two groups. One group will receive usual care; the other group will undertake a rehabilitation programme in addition to usual care. An online programme called ‘ActivateYourHeart’ has already been developed. It was designed to be used by many kinds of people with heart disease including those who cannot or do not want to attend group rehabilitation sessions. It can be used at home and can be completed at the participant’s own pace. An early preliminary study on people with stable angina indicates that it may be beneficial and that a larger trial is needed. People usually access this programme using their computer or their mobile device and the programme provides them with a tailored plan. However, before beginning the programme each participant receives face-to-face training using the website and a written user manual. A paper based version will also be available if people are not comfortable using the website. Before the start of the programme we will use questionnaires to measure physical limitations, the frequency and severity of chest pain, shortness of breath, quality of life, anxiety, depression, and the use of health services. We will also measure physical activity levels with a device worn continually for 7 days. These measurements will be repeated after 6 and 12 months. As well as comparing the effectiveness of the rehabilitation programme between the two groups, we will also assess its value for money, and whether the rehabilitation was delivered as intended._x000D_ _x000D_ Patient and public involvement_x000D_ There will be active patient and public involvement (PPI) in this study. Two PPI representatives (TC, EM) are co-applicants on this proposal. The proposal has been informed by a public advisory group. This group, led by TC and EM, will continue to advise on trial set-up and conduct._x000D_ _x000D_ Dissemination_x000D_ Results from the study will be presented at scientific meetings where interested doctors, therapists, nurses and health service commissioners will be present. We will write a final report and papers to appear in international journals. The results will be distributed to participants, policy makers, advisory groups, professional bodies and patient support groups.

Lay abstract: Research question _x000D_ 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?_x000D_ _x000D_ Background _x000D_ 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]. _x000D_ _x000D_ Objectives _x000D_ 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._x000D_ b) To determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme._x000D_ _x000D_ Methods _x000D_ 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. _x000D_ _x000D_ Timelines for delivery:_x000D_ 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)._x000D_ _x000D_ Anticipated impact and dissemination:_x000D_ 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.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL
Health categories: CARDIOVASCULAR