A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Pilot Study
| Autor: | Sally J Singh, Russell C. Davis, Fiona C Warren, Hayes Dalal, Christopher Hayward, Jennifer Wingham, Nicky Britten, Rod S Taylor, Karen Smith, Jackie Miles, Colin Green, Kate Jolly, Victoria Eyre, Colin J Greaves, Charles Abraham, Chim C. Lang, Susannah Sadler, Robin van Lingen, Melvyn Hillsdon, Patrick Doherty, Kevin Paul |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.medical_treatment Pilot Projects 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Intervention (counseling) medicine Humans 030212 general & internal medicine Child Aged Heart Failure Ejection fraction Rehabilitation business.industry Correction Stroke Volume General Medicine medicine.disease Home Care Services Clinical trial Self Care Caregivers Heart failure Physical therapy Quality of Life Female business Heart failure with preserved ejection fraction |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | Introduction Home-based cardiac rehabilitation may overcome suboptimal rates of participation. The overarching aim of this study was to assess the feasibility and acceptability of the novel Rehabilitation EnAblement in CHronic Hear Failure (REACH-HF) rehabilitation intervention for patients with heart failure with preserved ejection fraction (HFpEF) and their caregivers. Methods and results Patients were randomised 1:1 to REACH-HF intervention plus usual care (intervention group) or usual care alone (control group). REACH-HF is a home-based comprehensive self-management rehabilitation programme that comprises patient and carer manuals with supplementary tools, delivered by trained healthcare facilitators over a 12 week period. Patient outcomes were collected by blinded assessors at baseline, 3 months and 6 months postrandomisation and included health-related quality of life (primary) and psychological well-being, exercise capacity, physical activity and HF-related hospitalisation (secondary). Outcomes were also collected in caregivers. We enrolled 50 symptomatic patients with HF from Tayside, Scotland with a left ventricular ejection fraction ≥45% (mean age 73.9 years, 54% female, 100% white British) and 21 caregivers. Study retention (90%) and intervention uptake (92%) were excellent. At 6 months, data from 45 patients showed a potential direction of effect in favour of the intervention group, including the primary outcome of Minnesota Living with Heart Failure Questionnaire total score (between-group mean difference −11.5, 95% CI −22.8 to 0.3). A total of 11 (4 intervention, 7 control) patients experienced a hospital admission over the 6 months of follow-up with 4 (control patients) of these admissions being HF-related. Improvements were seen in a number intervention caregivers' mental health and burden compared with control. Conclusions Our findings support the feasibility and rationale for delivering the REACH-HF facilitated home-based rehabilitation intervention for patients with HFpEF and their caregivers and progression to a full multicentre randomised clinical trial to test its clinical effectiveness and cost-effectiveness. Trial registration number NCT78539530 |
| Databáze: | OpenAIRE |
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