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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

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