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BMJ Open. 2015 Dec 23;5(12):e009994. doi: 10.1136/bmjopen-2015-009994.

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.

Author information

1
Institute of Health Research, University of Exeter Medical School, Exeter, UK.
2
Peninsula Clinical Trials Unit, Plymouth University, Plymouth, Devon, UK.
3
Heart Failure Services and Cardiac Rehabilitation, Aneurin Bevan University Health Board, Nevill Hall Hospital, Abergavenny, UK.
4
Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.
5
Department of Health Sciences, University of York, York, UK.
6
Institute for Applied Health Research, University of Birmingham, Birmingham, UK.
7
Institute of Health Research, University of Exeter Medical School, Exeter, UK Department of Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
8
Cardiology Department, Royal Cornwall Hospitals NHS Trust, Truro, UK.
9
Psychology Applied to Health Group, University of Exeter Medical School, Exeter, UK.
10
Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.
11
Department of Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
12
REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.

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.

TRIAL REGISTRATION NUMBER:

ISRCTN86234930; Pre-results.

KEYWORDS:

REHABILITATION MEDICINE

PMID:
26700291
PMCID:
PMC4691763
DOI:
10.1136/bmjopen-2015-009994
[Indexed for MEDLINE]
Free PMC Article

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