Karen Smith1, Chim Lang2, Jennifer Wingham3, Julia Frost3, Colin Greaves4, Charles Abraham3,5, Fiona C Warren3, Joanne Coyle2, Kate Jolly6, Jackie Miles7, Kevin Paul8, Patrick J Doherty9, Russell Davies10, Hasnain Dalal11,12, Rod S Taylor13,14. 1. School of Nursing and Health Sciences, University of Dundee & NHS Tayside, Dundee, UK. 2. School of Medicine, University of Dundee & NHS Tayside, Dundee, UK. 3. Institute of Health Research, University of Exeter College of Medicine, Exeter, UK. 4. School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, UK. 5. School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, 3010, Australia. 6. Institute of Applied Health Research, University of Birmingham, Birmingham, UK. 7. Research and Development, Aneurin Bevan University Health Board, St Woolos Hospital, Newport, UK. 8. REACH-HF Patient and Public Involvement Group, c/o Research development and Innovation Royal Cornwall Hospitals NHS Trust, Truro, UK. 9. Department of Health Sciences, University of York, York, UK. 10. Cardiology Department, Sandwell & West Birmingham Hospitals NHS Trust, Birmingham, UK. 11. Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK. 12. Primary Care, University of Exeter Medical School, Truro Campus, Truro, UK. 13. Institute of Health Research, University of Exeter College of Medicine, Exeter, UK. rod.taylor@glasgow.ac.uk. 14. MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Top floor, 200, Renfield Street, Glasgow, G2 3AX, Scotland, UK. rod.taylor@glasgow.ac.uk.
Abstract
BACKGROUND: Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. METHODS: Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients' and caregivers' experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. RESULTS: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. CONCLUSIONS: The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. TRIAL REGISTRATION: ISRCTN78539530 (date of registration 7 July 2015).
RCT Entities:
BACKGROUND: Whilst almost 50% of heart failure (HF) patients have preserved ejection fraction (HFpEF), evidence-based treatment options for this patient group remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. METHODS: Process evaluation sub-study parallels to a single-centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients' and caregivers' experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and seven caregivers. RESULTS: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) responses to the REACH-HF intervention. Fidelity analysis found the interventions to be delivered adequately with scope for improvement in caregiver engagement. The differing professional backgrounds of REACH-HF facilitators in this study demonstrate the possibility of delivery of the intervention by healthcare staff with expertise in HF, cardiac rehabilitation, or both. CONCLUSIONS: The REACH-HF home-based facilitated intervention for HFpEF appears to be a feasible and a well-accepted model for the delivery of rehabilitation, with the potential to address key unmet needs of patients and their caregivers who are often excluded from HF and current cardiac rehabilitation programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial. TRIAL REGISTRATION: ISRCTN78539530 (date of registration 7 July 2015).
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