Process evaluation of a randomised pilot trial of home-based rehabilitation compared to usual care in patients with heart failure with preserved ejection fraction and their caregiver’s

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).

Benefits, Facilitators, and Barriers of Alternative Models of Cardiac Rehabilitation

“…Nineteen of 25 studies used home-based models, two of which were live video. Twelve of the studies included patients with heart failure (HF), [23][24][25][26][27][28][29][30][31][32][33][34] one included patients with stable angina, 35 one included patients with paroxysmal atrial fibrillation, 36 and one focused on patients who experienced transient ischemic attack. 37 Qualitative study methodology varied and the majority used either thematic or qualitative content analysis.…”

“…Anticipating or experiencing physical or psychological benefits 23,29,30,33,34,[36][37][38]73,76,78,79 2 10 5…”

Promising results from a residential rehabilitation intervention focused on fatigue and the secondary psychological and physical consequences of cardiac arrest: The SCARF feasibility study

“…A parallel qualitative interview study, with both groups, would have increased the depth of information and potentially identified problems and solutions not considered by the research team. 76,77 In a change from the protocol, we were unable to collect information on number of problems solved through the EC + PST due to the complexity of the information needed and the timeframe for the individual conversation. A future study could collect this data via qualitative means.…”