Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial

Taylor, R. S. et al. (2015) Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial. BMJ Open, 5(12), e009994. (doi: 10.1136/bmjopen-2015-009994) (PMID:26700291) (PMCID:PMC4691763)

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Abstract

Introduction The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) trial is part of a research programme designed to develop and evaluate a health professional facilitated, home-based, self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers. The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers. Methods and analysis A parallel two group randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) in 216 patients with systolic heart failure (ejection fraction <45%) and their caregivers. The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period. The primary outcome measure is patients’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure questionnaire at 12 months’ follow-up. Secondary outcomes include survival and heart failure related hospitalisation, blood biomarkers, psychological well-being, exercise capacity, physical activity, other measures of quality of life, patient safety and the quality of life, psychological well-being and perceived burden of caregivers at 4, 6 and 12 months’ follow-up. A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients. Qualitative studies will describe patient and caregiver experiences of the intervention. An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure. Ethics and dissemination The study is approved by the North West—Lancaster Research Ethics Committee (ref 14/NW/1351). Findings will be disseminated via journals and presentations to publicise the research to clinicians, commissioners and service users.

Item Type:Articles
Additional Information:Funding: This paper 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). NB, CA, CJG and RST are also supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust; KJ by CLAHRC West Midlands and SS by CLAHRC East-Midlands.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Taylor, Professor Rod
Authors: Taylor, R. S., Hayward, C., Eyre, V., Austin, J., Davies, R., Doherty, P., Jolly, K., Wingham, J., Van Lingen, R., Abraham, C.., Green, C., Warren, F.C., Britten, N., Greaves, C. =J., Singh, S., Buckingham, S., Paul, K., and Dalal, H.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO SPHSU
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:23 December 2015
Copyright Holders:Copyright © 2015 BMJ Publishing Group Limited
First Published:First published in BMJ Open 5(12):e009994
Publisher Policy:Reproduced under a Creative Commons license

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