Only 16% of UK cardiac rehabilitation centres offer a service for heart failure patients, leaving most without access to proven care. This programme addresses that gap by developing a home-based self-help manual—the HF Manual—for people with chronic heart failure and their caregivers. Currently, hospital-based cardiac rehabilitation improves quality of life and reduces hospital admissions, but uptake remains low because few centres provide it. The researchers will test whether a home-based programme can match the effectiveness of centre-based rehabilitation, and whether offering it as an option boosts participation. Over four work packages, they will develop the manual, run a pilot trial in patients with preserved ejection fraction, and conduct a full randomised controlled trial comparing the manual to usual care in 210 people with systolic heart failure across four UK centres. If successful, the HF Manual could give commissioners an evidence-based, cost-effective alternative to centre-based programmes, substantially improving the current suboptimal provision of cardiac rehabilitation for heart failure and reducing hospital admissions.
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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 in
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