Title: Rehabilitation Enablement in Chronic Heart Failure (REACH-HF)
Funder: Department of Health and Social Care

Abstract: Aims and objectives - The overarching aim of this programme is to improve a body of evidence-based knowledge for cardiac rehabilitation (CR) for heart failure (HF) in order to enhance the current low uptake of CR in HF and to inform future service commissioning. Specific objectives: to develop an evidence-informed, home-based, self-help CR programme for people with HF and their caregivers ('the HF Manual') to conduct a pilot trial to assess the effectiveness of the HF Manual in patients with HF with preserved ejection fraction (HFPEF) to assess the effectiveness and cost-effectiveness of the HF Manual vs. usual care in people systolic HF and their carergivers to assess the effectiveness and cost-effectiveness of the HF Manual vs. centre-based CR in people with systolic HF. Background and rationale - The prevalence of chronic HF is increasing worldwide, with a significant burden on individuals, their families and health services. A recently updated Cochrane review found important improvements in quality of life and reductions in hospital admissions in people with systolic HF following hospital-based CR.[2] Based on this evidence, in 2010 the National Institute for Health and Clinical Excellence (NICE) recommended supervised group exercise-based CR programme for people with HF.[1] However, our recent national UK survey shows that only 16% of centres specifically provide a CR service for HF ([3] and abstract of manuscript in preparation in Supporting Documentation section). Trials have shown that home-based CR programmes after myocardial infarction and revascularisation are as effective as centre-based programmes and that offering a choice of home- or centre-based CR can improve uptake. In the absence of evidence-based home CR programmes for HF, there is an urgent need to develop, evaluate and introduce to the NHS such an intervention. Research plans and outputs The programme consists of four distinct but conceptually linked work packages: Work Package 1 will use systematic intervention development methods to develop a home-based self-help manual for people with systolic HF and their caregivers ('the HF Manual'). Work Package 2 will conduct a pilot trial in Birmingham to assess the feasibility of a definitive trial of the effectiveness of the HF Manual in patients with HFPEF.50 individuals will be randomised to intervention or control and followed up for 12 months. Work Package 3 will involve a randomised controlled trial to assess the effectiveness and cost-effectiveness of HF Manual vs. usual care. 210 people with systolic HF will be recruited from four centres (Abergavenny/South Wales, Birmingham, Cornwall and York). Prior to the main trial, a 6-month pilot phase will check trial feasibility and intervention acceptability. Main trial outcome measures will be collected at baseline and 6 and 12 months after randomisation. Work Package 4 will use evidence synthesis/modelling methods to bring together the trial evidence on home- and centre-based CR to assess the effectiveness and cost-effectiveness of the HF Manual (home-based CR) vs. centre-based CR. Work Packages 3 and 4 will provide commissioners with evidence on the effectiveness and cost-effectiveness of the HF Manual vs. usual care and vs. centre-based CR. We believe that an evidence-based home CR intervention could substantially improve the current suboptimal provision of CR in HF and thereby result in important improvements in patient and caregiver health outcomes and reductions in hospital admissions. Research team and environment - Our team comprises a collaborative partnership of individuals with proven ability to deliver successful research in CR and HF. It includes expertise in methodology (trial design, management and statistics; health behaviour change; psychology; health economics; qualitative research and evidence synthesis) and clinical practice (cardiology, delivery of CR; primary care; physiotherapy; nursing) and intimately works alongside service users. The research team uniquely brings together the investigators who have led and published the five major RCTs of CR in the UK. We have proven track records through publications, research funding, service on national committees and adoption of our work in national guidelines. Justification of costs - The four work packages are conceptually linked to maximise the programme's research output and value for money. Management and governance - An overarching Operational Steering Committee (with independent chair) will oversee the management and governance of the programme, with direct reporting lines from a PPI Advisory Group, Work Groups for the four work packages, and Trial Steering and Data Monitoring/Events Committees. Patient and public involvement - We have intimately involved individuals with HF and experience of CR since the outset of the Programme Development Grant. They have attended project meetings and have made important contributions that have resulted in changes to the research methods and processes (see Supporting Documentation section). A PPI Advisory Group has been established that directly feeds into the Programme Operational Steering Committee and one patient representative is an applicant (JP).

Lay abstract: In the UK, nearly a million people are living with HF, costing the NHS up to &pound;1 billion/year. A recently updated Cochrane review of exercise-based cardiac rehabilitation (CR) found important improvements in quality of life and reductions in hospital admissions in people with systolic heart failure (HF) following CR compared to usual care. National Institute for Health and Clinical Excellence guidance[1] recommends centre-/group exercise- based CR for HF (both systolic HF and HF with preserved ejection fraction [HFPEF]). However, national surveys show that only a small minority of those with HF currently receive CR. Previous research has shown that CR uptake improves when individuals following myocardial infarction or revascularisation are offered a choice of centre-based or home-based CR programme. There is now an urgent need to develop, evaluate and introduce CR for individuals with heart failure that supports caregivers to the NHS. In this programme, we intend to: develop, in collaboration with patients, carers, clinicians and academics, a home-based, self-help CR programme ('the HF Manual') for people with HF and their caregivers conduct a pilot trial to assess the feasability of a definitive trial of the HF Manual in HFPEF undertake a multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of the HF Manual vs. usual care in people with systolic HF and their caregivers use evidence synthesis/modelling to assess the effectiveness and cost-effectiveness of the HF Manual vs. centre-based CR in systolic HF. Patients will be recruited from England (Birmingham, Cornwall and York) and Wales (Abergavenny/South Wales). Expected benefits/outcomes: For patients: an evidence-informed, patient-centred, self-help HF Manual for people with systolic HF and their caregivers, which can improve quality of life and reduce both hospital admissions and caregiver stress. For commissioners: evidence of the effectiveness and cost-effectiveness of a home-based CR intervention that could lead to important improvements in the current low uptake of CR, thereby enhancing patient and caregiver health outcomes, reducing hospitalisations and reducing NHS costs. For research commissioners this programme will also provide a better understanding of the feasibility of a definitive future RCT of HF manual vs usual care in HFPEF. We believe there to be no particular ethical implications of this programme in addition to the usual requirements of patient research involvement. Our research team uniquely brings together the investigators who led and published the five major trials of CR in the UK. The team has expertise in methodology (medical statistics; health economics; qualitative research; psychology; health behaviour change; evidence synthesis and modelling) and clinical practice (cardiology; primary care; CR; physiotherapy) and intimately involves service users. The Heart Manual Service, NHS Lothian (with extensive experience in delivery and implementation of the Heart Manual for people after myocardial infarction/revascularisation) is a key collaborator.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR