We have evaluated the clinical effectiveness, cost effectiveness and acceptability of the manual for people with heart failure and their caregivers.
Our research team benefits from the involvement of the investigators who led and published several major trials of cardiac rehabilitation 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, cardiac rehabilitation, nursing and physiotherapy), and uniquely 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 or revascularisation) is a key collaborator.
REACH-HF is an independent research programme funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (Reference Number RP-PG-1210-12004). It builds upon work previously conducted by the research team during an NIHR Programme Development Grant award (Reference Number RP-DG-0709-10111). The views expressed are those of the research team and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
This work package used systematic intervention development methods to develop a home based self-help manual for people with systolic heart failure and their caregivers (‘the HF Manual’). It was divided into two sections:
Research Question: What are the necessary intervention components of a home-based, self-help manual for people with HF?
Research Question: What are the necessary intervention components of a home-based, self-help manual for the caregivers of people with HF?
This work package used qualitative research methods. The study was informed by thematic analysis involving 26 caregivers in individual interviews or a focus group. Read the full study here.
Work Package 1 includes a feasibility study to assess the feasibility and acceptability of the REACH-HF Manual for patients, caregivers and facilitators.
Research Question: How feasible is the HF-manual in people with heart failure?
This work package will conduct a pilot trial to assess the feasibility of a definitive trial of the heart failure manual in people who have a type of heart failure called heart failure with preserved ejection fraction (HFPEF). Read the rationale for Work Package 2 here.
Research Questions: What is the effectiveness and cost effectiveness of the HF manual vs. usual care in people with systolic HF? What is the impact for caregivers of using the HF Manual vs. usual care?
This work package conducted a randomised controlled trial to assess the effectiveness and cost effectiveness of HF Manual vs. usual care. 216 people with systolic HF were recruited from four centres (Abergavenny/South Wales, Birmingham, Cornwall and York). Prior to the main trial, a 6-month pilot phase checked trial feasibility and intervention acceptability. Main trial outcome measures were collected at baseline and 6 and 12 months after randomisation. A process evaluation included assessing trial fidelity; evaluating patient and caregiver experience of using the manual and measurement of caregiver stress.
The results are being analysed now and expected in 2018. Read the rationale for Work Package 2 here.
Research Questions: What is the effectiveness and cost effectiveness of the HF Manual vs. centre based CR in people with systolic HF? What is the expected value of information for future research, including a randomised controlled trial of the HF manual vs. centre-based CR in people with systolic HF?
This work will use evidence synthesis/modelling methods to bring together the trial evidence on home and centre based cardiac rehabilitation. After this is complete, the effectiveness and cost effectiveness of the HF Manual (home based CR) vs. centre based CR will be assessed.
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. This would thereby result in important improvements in patient and caregiver health outcomes and reductions in hospital admissions.