Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated selfcare rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial.
dc.contributor.author | Hayward, CJ | |
dc.contributor.author | Taylor, RS | |
dc.contributor.author | Eyre, V | |
dc.date.accessioned | 2015-12-24T10:39:43Z | |
dc.date.available | 2015-12-24T10:39:43Z | |
dc.date.issued | 2015-12-24 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.other | ARTN e009994 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/3991 | |
dc.description.abstract |
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 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN86234930; Pre-results. | |
dc.format.extent | e009994-e009994 | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMJ | |
dc.subject | REHABILITATION MEDICINE | |
dc.title | Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated selfcare rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial. | |
dc.type | journal-article | |
dc.type | Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/26700291 | |
plymouth.edition | 2015 | |
plymouth.issue | 5 | |
plymouth.volume | 5 | |
plymouth.publication-status | Published | |
plymouth.journal | BMJ Open | |
dc.identifier.doi | 10.1136/bmjopen-2015-009994 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | England | |
dc.identifier.eissn | 2044-6055 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1136/bmjopen-2015-009994 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.type | Journal Article/Review |