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), and 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.
The REACH-HF feasibility study was a multicentre single-arm feasibility study with parallel process evaluation to assess the feasibility and acceptability of the REACH-HF manual for systolic HF patients, their caregivers and facilitators delivering the intervention. The feasibility study was conducted in preparation for a fully powered randomised controlled trial assessing the clinical effectiveness and cost effectiveness of the HF Manual vs usual care in patients with systolic HF and a separate single centre pilot trial in patients with heart failure with preserved ejection fraction (HFpEF).
Intervention development aims:
The study used a four centre (Birmingham, Cornwall, South Glamorgan and York) single-arm design with a parallel process evaluation. Following identification and recruitment, patients with systolic HF received the HF manual intervention which was delivered over a period of 12 weeks by trained intervention facilitators, in addition to their usual care.
The parallel process evaluation utilised a range of qualitative methods including recordings of intervention sessions, satisfaction questionnaires and interviews with both patients and caregivers, in addition to an observed structured clinical assessment using an intervention fidelity checklist in the context of delivering the REACH-HF Manual to people with systolic HF. Multiple rounds of data collection and interaction with the intervention facilitators delivering the intervention generated feedback that informed both changes to the HF Manual, and changes to the training materials (i.e. the way the HF Manual is delivered by the intervention facilitators). The patient and caregiver outcome measures for the main trial of clinical effectiveness and cost-effectiveness were collected pre- and post- intervention in this study, in order to test procedures for collection, burden for patients, completeness of data collection and the rate of patient attrition/loss to follow up.
Recruitment of patients and their caregivers took place over the 12 week period from 1 March 2014 to 31 May 2014, a one-month extension on the planned 2-month period due to delayed Excess Treatment Costs (ETC) agreement and delayed recruitment start at one centre (York). A total of 23 patients and 12 caregivers were recruited – meeting the recruitment target for the study. A total of eight intervention facilitators were recruited.
This article presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1210-12004). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
This work consisted of a survey of current provision of cardiac rehabilitation, a qualitative synthesis of the experiences, attitudes, beliefs and expectations of self-management of heart failure and a systematic review and meta-analysis of cardiac rehabilitation (CR) in people with HFPEF.
Full data were available for 84% (232/277) CR centres across England, Wales and Northern Ireland. Only 40% routinely offered CR to patients with HF. Only 16% (35/224) of respondents provide a dedicated CR service for patients with HF. Lack of resources and commissioning are seen as major barriers to offering CR in this group.
Dalal H M, Wingham J, Palmer J, Taylor R, Petre C, Lewin R. Why do so few patients with heart failure participate in cardiac rehabilitation? A cross-sectional survey from England, Wales and Northern Ireland. BMJ Open, 2012, 2(2). Read the full survey here.
The following systematic reviews have been published by the research team:
Taylor R, Davies EJ, Dalal HM, Davis R, Doherty P, Cooper C, Holland DJ, Jolly K, Smart NA. Effects of exercise training for heart failure with preserved ejection fraction: A systematic review and meta-analysis of comparative studies. International Journal of Cardiology, 2012,162(1):6-13.
Read the full review here.
Brown JP, Clark AM, Dalal H, Welch K, Taylor RS. Effect of patient education in the management of coronary heart disease: a systematic review and meta-analysis of randomized controlled trials. European Journal of Preventive Cardiology, 2013 Aug, 20(4):701-14. Read the full review here.
Anderson L & Taylor RS. Cardiac rehabilitation for people with heart disease: an overview of Cochrane systematic reviews. Cochrane Database of Systematic Reviews, 2014 Dec, 12:CD011273. Read the full review here.
Sagar VA, Davies EJ, Briscoe S, Coats AJ, Dalal HM, Lough F, Rees K, Singh S, Taylor RS. Exercise-based rehabilitation for heart failure: systematic review and meta-analysis. Open Heart, 2015 Jan, 2(1):e000163. Read the full review here.
Taylor RS, Dalal H, Jolly K, Zawada A, Dean SG, Cowie A, Norton RJ. Home-based versus centre-based cardiac rehabilitation.Cochrane Database of Systematic Reviews, 2015 Aug, 8:CD007130. Read the full review here.
Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease: Cochrane systematic review and meta-analysis. Journal of the American College of Cardiology, 2016 Jan, 67(1):1-12. Read the full review here.
Nineteen qualitative studies were identified. Our resultant five phase conceptual model starts with patients’ initial experiences of disruption across physical, emotional, social and psychological domains. Patients then pass through four more phases beginning with a sense making phase influenced by knowledge, their engagement with health professionals and their personal attributes.
The next phase is ‘reaction’ during which patients adopt one of four reactions: strategic avoider; selective denier; well-intentioned self-manager; advanced self-manager. The next phase of response is partially dependent on social factors including support from caregivers. Finally, patients seek to assimilate their management into daily life.
Wingham, J, Harding, G, Britten, N, Dalal, H. Heart failure patients’ attitudes, beliefs, expectations and experiences of self-management strategies: A qualitative synthesis. Chronic Illness, 2014 Jun, 10(2):135-54. Read the full qualitative review here.
As a prelude to the development of the HF Manual, we have engaged with individuals with HF (through focus groups and questionnaires) and key healthcare staff to explore the needs of HF and treatment goals.
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 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.
Dr Hasnain (Hayes) Dalal qualified from the University of Sheffield in 1981 and is the joint lead investigator on the REACH-HF study. He was a GP partner at the Three Spires Medical Practice in Truro until his retirement from General Practice in March 2015. He is currently a senior clinical researcher at the Royal Cornwall Hospitals NHS Trust and honorary clinical associate professor at the University of Exeter Medical School.
Since 1997 Dr. Dalal has conducted various NHS funded research projects in collaboration with patients, clinicians and academics involving heart disease and rehabilitation.
Rod Taylor is the joint lead on the REACH-HF Project. He is currently Professor of Health Services Research and Academic lead for the Exeter Clinical Trials Support Network at the Exeter Medical School, University of Exeter in UK and National Institute of Health Research (NIHR) Senior Investigator. His former academic appointments include the London School of Hygiene and Tropical Medicine and the Universities of Birmingham and Glasgow and he was first Director of Technology Appraisals at the National Institute for Health and Care Excellence (NICE).
He has published over 230 peer review articles the field of health services research and health technology assessment. Rod’s main research interests include development and evaluation of secondary prevention and rehabilitation strategies for heart disease, clinical trial design for complex interventions, use of surrogate outcomes in clinical trials and reimbursement health care policy, and comparative effectiveness research for evaluation of medical devices.
Supported by an NIHR Programme Grant and in collaboration with Cochrane Heart Group in 2009-2011 he led a programme of research that included production of the current six Cochrane reviews of cardiac rehabilitation. He was co-investigator on the three previous UK randomised controlled trials (CHARMS, BRUM and BRUM-HF) of home-based cardiac rehabilitation in post-MI, post-vascularisation and heart failure populations.
Rod is currently Chair of NIHR Research, Health Service & Development Research Panel and South West RfPB funding panel, and Core member of NIHR HTA Themed Call Board, NIHR Health Services and Delivery Research Researcher-Led panel, 2013-present and Core group of Methodological Experts for the NIHR Programme Grants for Applied Research programme. He is a member of the editorial board for International Journal of Technology Assessment in Health Care, European Journal of Preventive Cardiology, Pain Practice, Neuromodulation, Cochrane Heart Group and acts as methodological reviewer for a number of peer review journals.