A pilot randomised trial of home-based rehabilitation compared to usual care in patients with heart failure with preserved ejection fraction and their caregiver’s (REACH-HFpEF study): a process evaluation.

Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is emerging 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. This study reports the process evaluation conducted as part of the REACH-HFpEF trial. Methods: Mixed methods Pprocess evaluation sub study parallel to a single centre (Tayside, Scotland) pilot randomised controlled trial with qualitativequantitative assessment of both intervention fidelity delivery and a qualitative exploration of HFpEF patients’ and caregivers’ experiences. The Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Data included audio-recorded intervention sessions; demographic information; intervention fidelity scores; and qualitative interviews conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers.,Results: Intervention fidelity analysis was indicative of the adequate delivery of the majority of the REACH-HF components, with three items relating caregiver involvement (addressing emotional consequences of being a caregiver, caregiver health and well-being, and closure of the session) scoring poorly. Qualitative information from the facilitator interactions and interviews identified three key themes and a number of sub-themes for patients and caregivers: (1) understanding their condition (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention were uncovered by qualitative interviews. Different professional backgrounds and typical models of service delivery of facilitators demonstrate to possibility of delivering this through either our HF or CR services of a combination of the two.Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a CR intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results of this study will inform a future recently funded full multicentre randomised clinical trial.