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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