Objective To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.
Design Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).
Setting Four centres in the UK (Birmingham, Cornwall, Gwent and York).
Participants People with heart failure with reduced ejection fraction (HFrEF) and their caregivers.
Methods The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.
Outcome measures Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.
Results Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.
Conclusions By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.
Trial registration number ISRCTN25032672; Pre-results.
- heart failure
- primary care
- qualitative research
- rehabilitation medicine
- clinical trials
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Contributors HD, RT, PJD, KJ, JM, JW, NB, CG, CA, and SJS designed the trial, were responsible for its conduct, and obtained trial funding. CG led the design of the intervention, with strong contributions from JW, PJD, the Heart Manual Department (Edinburgh), and the REACH-HF service user advisory group. JF, JW, NB, CG and CA designed the qualitative study and conducted the data analysis. FCW undertook the statistical analysis. JF led the mixed methods analysis. KP represented patient and public involvement on the Programme Management Group and liaised with the patient involvement group throughout the study. He commented upon the manuscript. All authors contributed to writing and editing the manuscript, with the lead taken by JF. All authors commented on the manuscript and agreed the final version. JF and RT are the guarantors.
Funding REACH-HF was funded by a Programme Grant for Applied Research (RP-PG-1210-12004) awarded by the National Institute for Health Research (NIHR). Nicky Britten and Charles Abraham are part-funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula. Kate Jolly is part-funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West Midlands.
Competing interests None declared.
Ethics approval Ethical approval was granted by the North West— Lancaster Research Ethics Committee (ref 14/NW/1351). Trial registration number ISRCTN86234930.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Transcripts will not be shared in their entirety to protect the anonymity of participants and workers delivering the interventions. However, requests for excerpts of the data will be considered on an individual basis. Please contact the corresponding author.
Patient consent for publication Obtained.
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