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
dc.contributor.author | Eyre, Victoria | |
dc.contributor.author | Lang, CC | |
dc.contributor.author | Smith, K | |
dc.contributor.author | Jolly, K | |
dc.contributor.author | Davis, R | |
dc.contributor.author | Hayward, C | |
dc.contributor.author | Wingham, J | |
dc.contributor.author | Abraham, C | |
dc.contributor.author | Green, C | |
dc.contributor.author | Warren, FC | |
dc.contributor.author | Britten, N | |
dc.contributor.author | Greaves, CJ | |
dc.contributor.author | Doherty, P | |
dc.contributor.author | Austin, J | |
dc.contributor.author | Van Lingen, R | |
dc.contributor.author | Singh, S | |
dc.contributor.author | Buckingham, Sarah | |
dc.contributor.author | Paul, K | |
dc.contributor.author | Taylor, RS | |
dc.contributor.author | Dalal, HM | |
dc.date.accessioned | 2021-08-09T10:44:18Z | |
dc.date.available | 2021-08-09T10:44:18Z | |
dc.date.issued | 2016-10 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.other | ARTN e012853 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/17445 | |
dc.description.abstract |
INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN78539530; Pre-results . | |
dc.format.extent | e012853-e012853 | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | BMJ | |
dc.subject | Cardiac Rehabilitation | |
dc.subject | Caregivers | |
dc.subject | Complex Intervention | |
dc.subject | Preserved Ejection Fraction | |
dc.subject | Randomised Controlled Trial | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Caregivers | |
dc.subject | Chronic Disease | |
dc.subject | Exercise | |
dc.subject | Female | |
dc.subject | Heart Failure | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Pilot Projects | |
dc.subject | Quality of Life | |
dc.subject | Research Design | |
dc.subject | Self Care | |
dc.subject | Stroke Volume | |
dc.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 | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Randomized Controlled Trial | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000391303200043&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 10 | |
plymouth.volume | 6 | |
plymouth.publication-status | Published | |
plymouth.journal | BMJ Open | |
dc.identifier.doi | 10.1136/bmjopen-2016-012853 | |
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-2016-012853 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.type | Journal Article/Review |