title: Rehabilitation Enablement in Chronic Heart Failure-a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial.
abstract: The Rehabilitation EnAblement in CHronic Heart Failure in patients with Heart Failure (HF) with preserved ejection fraction (REACH-HFpEF) pilot trial is part of a research programme designed to develop and evaluate a facilitated, home-based, self-help rehabilitation intervention to improve self-care and quality of life (QoL) in heart failure patients and their caregivers. We will assess the feasibility of a definitive trial of the REACH-HF intervention in patients with HFpEF and their caregivers. The impact of the REACH-HF intervention on echocardiographic outcomes and bloodborne biomarkers will also be assessed.
  
  
  
  A single-centre parallel two-group randomised controlled trial (RCT) with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention) or usual care alone (control) in 50 HFpEF patients and their caregivers. The REACH-HF intervention comprises a REACH-HF manual with supplementary tools, delivered by trained facilitators over 12 weeks. A mixed methods approach will be used to assess estimation of recruitment and retention rates; fidelity of REACH-HF manual delivery; identification of barriers to participation and adherence to the intervention and study protocol; feasibility of data collection and outcome burden. We will assess the variance in study outcomes to inform a definitive study sample size and assess methods for the collection of resource use and intervention delivery cost data to develop the cost-effectiveness analyses framework for any future trial. Patient outcomes collected at baseline, 4 and 6 months include QoL, psychological well-being, exercise capacity, physical activity and HF-related hospitalisation. Caregiver outcomes will also be assessed, and a substudy will evaluate impact of the REACH-HF manual on resting global cardiovascular function and bloodborne biomarkers in HFpEF patients.
  
  
  
  The study is approved by the East of Scotland Research Ethics Service (Ref: 15/ES/0036). Findings will be disseminated via journals and presentations to clinicians, commissioners and service users.
  
  
  
  ISRCTN78539530; Pre-results .
authors: Peninsula Clinical Trials Unit, Plymouth University, Plymouth, UK.
authors: V
authors: 0000-0003-0927-6815
authors: V
authors: Eyre
authors: School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors: C C
authors: CC
authors: Lang
authors: School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.|School of Nursing & Midwifery, Dundee University, Dundee, UK.
authors: K
authors: K
authors: Smith
authors: Institute for Applied Health Research, University of Birmingham, Birmingham, UK.
authors: K
authors: K
authors: Jolly
authors: Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK.
authors: R
authors: R
authors: Davis
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: C
authors: C
authors: Hayward
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.|Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors: J
authors: J
authors: Wingham
authors: Psychology Applied to Health Group, University of Exeter Medical School, Exeter, UK.
authors: C
authors: C
authors: Abraham
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: C
authors: C
authors: Green
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: F C
authors: FC
authors: Warren
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: N
authors: N
authors: Britten
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: C J
authors: CJ
authors: Greaves
authors: Department of Health Sciences, University of York, York, UK.
authors: P
authors: P
authors: Doherty
authors: Heart Failure Services and Cardiac Rehabilitation, Aneurin Bevan University Health Board, Nevill Hall Hospital, Abergavenny, UK.
authors: J
authors: J
authors: Austin
authors: Cardiology Department, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors: R
authors: R
authors: Van Lingen
authors: Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.
authors: S
authors: S
authors: Singh
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: S
authors: S
authors: Buckingham
authors: REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors: K
authors: K
authors: Paul
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors: R S
authors: RS
authors: Taylor
authors: Institute of Health Research, University of Exeter Medical School, Exeter, UK.|Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.
authors: H M
authors: HM
authors: Dalal
mesh_terms: D000293:Adolescent; D000328:Adult; D017028:Caregivers; D002908:Chronic Disease; D015444:Exercise; D005260:Female; D006333:Heart Failure / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D013318:Stroke Volume
keywords: Cardiac Rehabilitation; Caregivers; Complex Intervention; Preserved Ejection Fraction; Randomised Controlled Trial