title: 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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN86234930; Pre-results.
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: R S
authors.initials: RS
authors.lastname: Taylor
authors.affiliation: Peninsula Clinical Trials Unit, Plymouth University, Plymouth, Devon, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hayward
authors.affiliation: Peninsula Clinical Trials Unit, Plymouth University, Plymouth, Devon, UK.
authors.forename: V
authors.initials: V
authors.lastname: Eyre
authors.affiliation: Heart Failure Services and Cardiac Rehabilitation, Aneurin Bevan University Health Board, Nevill Hall Hospital, Abergavenny, UK.
authors.forename: J
authors.initials: J
authors.lastname: Austin
authors.affiliation: Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.
authors.forename: R
authors.initials: R
authors.lastname: Davies
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: P
authors.initials: P
authors.lastname: Doherty
authors.affiliation: Institute for Applied Health Research, University of Birmingham, Birmingham, UK.
authors.forename: K
authors.initials: K
authors.lastname: Jolly
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK Department of Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors.forename: J
authors.initials: J
authors.lastname: Wingham
authors.affiliation: Cardiology Department, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors.forename: R
authors.initials: R
authors.lastname: Van Lingen
authors.affiliation: Psychology Applied to Health Group, University of Exeter Medical School, Exeter, UK.
authors.forename: C
authors.initials: C
authors.lastname: Abraham
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: C
authors.initials: C
authors.lastname: Green
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: F C
authors.initials: FC
authors.lastname: Warren
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: N
authors.initials: N
authors.lastname: Britten
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: C J
authors.initials: CJ
authors.lastname: Greaves
authors.affiliation: Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.
authors.forename: S
authors.initials: S
authors.lastname: Singh
authors.affiliation: Department of Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors.forename: S
authors.initials: S
authors.lastname: Buckingham
authors.affiliation: REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors.forename: K
authors.initials: K
authors.lastname: Paul
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK Department of Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors.forename: H
authors.initials: H
authors.lastname: Dalal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers; D002908:Chronic Disease; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000191:economics / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012648:Self Care / Q000191:economics / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
keywords: REHABILITATION MEDICINE