Rehabilitation Enablement in Chronic Heart Failure
REACH-HF
Posted by sv333
22 May 2019The REACH-HF feasibility study was a multicentre single-arm feasibility study with parallel process evaluation to assess the feasibility and acceptability of the REACH-HF manual for systolic HF patients, their caregivers and facilitators delivering the intervention. The feasibility study was conducted in preparation for a fully powered randomised controlled trial assessing the clinical effectiveness and cost effectiveness of the HF Manual vs usual care in patients with systolic HF and a separate single centre pilot trial in patients with heart failure with preserved ejection fraction (HFpEF).
The study used a four centre (Birmingham, Cornwall, South Glamorgan and York) single-arm design with a parallel process evaluation. Following identification and recruitment, patients with systolic HF received the HF manual intervention which was delivered over a period of 12 weeks by trained intervention facilitators, in addition to their usual care.
The parallel process evaluation utilised a range of qualitative methods including recordings of intervention sessions, satisfaction questionnaires and interviews with both patients and caregivers, in addition to an observed structured clinical assessment using an intervention fidelity checklist in the context of delivering the REACH-HF Manual to people with systolic HF. Multiple rounds of data collection and interaction with the intervention facilitators delivering the intervention generated feedback that informed both changes to the HF Manual, and changes to the training materials (i.e. the way the HF Manual is delivered by the intervention facilitators). The patient and caregiver outcome measures for the main trial of clinical effectiveness and cost-effectiveness were collected pre- and post- intervention in this study, in order to test procedures for collection, burden for patients, completeness of data collection and the rate of patient attrition/loss to follow up.
Recruitment of patients and their caregivers took place over the 12 week period from 1 March 2014 to 31 May 2014, a one-month extension on the planned 2-month period due to delayed Excess Treatment Costs (ETC) agreement and delayed recruitment start at one centre (York). A total of 23 patients and 12 caregivers were recruited – meeting the recruitment target for the study. A total of eight intervention facilitators were recruited.