Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial
Introduction Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence...
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BMJ Publishing Group
2025-05-01
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| author | John G F Cleland Kate Jolly Christi Deaton Louise Taylor Rod S Taylor Aynsley Cowie Alex McConnachie Julia Frost Colin Greaves Chim C Lang Emma McIntosh Valerie Smith Samantha van Beurden Patrick J Doherty Hasnain M Dalal Tracy Ibbotson Melvyn Hillsdon Anna Placzek Jessica C Bollen Iain Squire Emma Burrell Nick Hartshorne-Evans Elizabeth A Thomson Claire O’Hare Katie Dudman Heather Fraser Mohammad Jarallah |
| author_facet | John G F Cleland Kate Jolly Christi Deaton Louise Taylor Rod S Taylor Aynsley Cowie Alex McConnachie Julia Frost Colin Greaves Chim C Lang Emma McIntosh Valerie Smith Samantha van Beurden Patrick J Doherty Hasnain M Dalal Tracy Ibbotson Melvyn Hillsdon Anna Placzek Jessica C Bollen Iain Squire Emma Burrell Nick Hartshorne-Evans Elizabeth A Thomson Claire O’Hare Katie Dudman Heather Fraser Mohammad Jarallah |
| author_sort | John G F Cleland |
| collection | DOAJ |
| description | Introduction Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.Methods and analysis REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.Ethics and dissemination The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.Trial registration number ISRCTN47894539. |
| format | Article |
| id | doaj-art-03c1fcf5bd964a6b9fd11596af7308f5 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-03c1fcf5bd964a6b9fd11596af7308f52025-08-20T02:34:40ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-094254Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trialJohn G F Cleland0Kate Jolly1Christi Deaton2Louise Taylor3Rod S Taylor4Aynsley Cowie5Alex McConnachie6Julia Frost7Colin Greaves8Chim C Lang9Emma McIntosh10Valerie Smith11Samantha van Beurden12Patrick J Doherty13Hasnain M Dalal14Tracy Ibbotson15Melvyn Hillsdon16Anna Placzek17Jessica C Bollen18Iain Squire19Emma Burrell20Nick Hartshorne-Evans21Elizabeth A Thomson22Claire O’Hare23Katie Dudman24Heather Fraser25Mohammad Jarallah26School of Cardiovascular & Metabolic Health, University of Glasgow, Glasgow, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKCambridge Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UKHeart Manual Department, Lothian Health Board, Edinburgh, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKCardiac Rehabilitation, NHS Ayrshire and Arran, Kilmarnock, UKRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UKMedical School, University of Exeter, Exeter, UKSchool of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham, UKDivision of Cardiovascular Research, University of Dundee, Dundee, UKHealth Economics and Health Technology Assessment (HEHTA), University of Glasgow, Glasgow, UKUniversity College Dublin School of Nursing Midwifery and Health Systems, Dublin, IrelandUniversity of Exeter, Exeter, UKHealth Science, University of York, York, Yorkshire, UKResearch, Development and Innovation, Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UKInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UKUniversity of Exeter, Exeter, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKMedical School, University of Exeter, Exeter, UKGlenfield Hospital, Leicester, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKPumping Marvellous Foundation, Preston, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKSchool of Health & Wellbeing, University of Glasgow, Glasgow, UKHealth Economics and Health Technology Assessment (HEHTA), University of Glasgow, Glasgow, UKUniversity of Birmingham, Birmingham, UKIntroduction Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.Methods and analysis REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.Ethics and dissemination The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.Trial registration number ISRCTN47894539.https://bmjopen.bmj.com/content/15/5/e094254.full |
| spellingShingle | John G F Cleland Kate Jolly Christi Deaton Louise Taylor Rod S Taylor Aynsley Cowie Alex McConnachie Julia Frost Colin Greaves Chim C Lang Emma McIntosh Valerie Smith Samantha van Beurden Patrick J Doherty Hasnain M Dalal Tracy Ibbotson Melvyn Hillsdon Anna Placzek Jessica C Bollen Iain Squire Emma Burrell Nick Hartshorne-Evans Elizabeth A Thomson Claire O’Hare Katie Dudman Heather Fraser Mohammad Jarallah Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial BMJ Open |
| title | Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial |
| title_full | Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial |
| title_fullStr | Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial |
| title_full_unstemmed | Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial |
| title_short | Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial |
| title_sort | clinical effectiveness and cost effectiveness of the rehabilitation enablement in chronic heart failure facilitated self care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers rationale and protocol for a multicentre randomised controlled trial reach hfpef trial |
| url | https://bmjopen.bmj.com/content/15/5/e094254.full |
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