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

被引:26
|
作者
Taylor, R. S. [1 ]
Hayward, C. [2 ]
Eyre, V. [2 ]
Austin, J. [3 ]
Davies, R. [4 ]
Doherty, P. [5 ]
Jolly, K. [6 ]
Wingham, J. [1 ,7 ]
Van Lingen, R. [8 ]
Abraham, C. [9 ]
Green, C. [1 ]
Warren, F. C. [1 ]
Britten, N. [1 ]
Greaves, C. J. [1 ]
Singh, S. [10 ]
Buckingham, S. [7 ]
Paul, K. [11 ]
Dalal, H. [1 ,7 ]
机构
[1] Univ Exeter, Sch Med, Inst Hlth Res, Exeter, Devon, England
[2] Univ Plymouth, Peninsula Clin Trials Unit, Plymouth PL4 8AA, Devon, England
[3] Aneurin Bevan Univ Hlth Board, Nevill Hall Hosp, Heart Failure Serv & Cardiac Rehabil, Abergavenny, Wales
[4] Sandwell & West Birmingham Hosp NHS Trust, Dept Cardiol, Birmingham, W Midlands, England
[5] Univ York, Dept Hlth Sci, York YO10 5DD, N Yorkshire, England
[6] Univ Birmingham, Inst Appl Hlth Res, Birmingham, W Midlands, England
[7] Royal Cornwall Hosp NHS Trust, Dept Res Dev & Innovat, Truro, England
[8] Royal Cornwall Hosp NHS Trust, Dept Cardiol, Truro, England
[9] Univ Exeter, Sch Med, Psychol Appl Hlth Grp, Exeter, Devon, England
[10] Univ Hosp Leicester NHS Trust, Ctr Exercise & Rehabil Sci, Leicester, Leics, England
[11] Royal Cornwall Hosp NHS Trust, Res Dev & Innovat, REACH HF Patient & Publ Involvement Grp, Truro, England
来源
BMJ OPEN | 2015年 / 5卷 / 12期
基金
美国国家卫生研究院;
关键词
REHABILITATION MEDICINE; QUALITY-OF-LIFE; EXERCISE; ASSOCIATION;
D O I
10.1136/bmjopen-2015-009994
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 12months' 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 12months' 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 WestLancaster 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.
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页数:11
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