Regaining Confidence after Stroke (RCAS): a feasibility randomised controlled trial (RCT)

Background: The Regaining Confidence after Stroke Course (RCAS) was designed to facilitate adjustment for people with stroke discharged from rehabilitation. The aim of the trial was to evaluate the feasibility of conducting a randomised trial to compare a RCAS course with usual care. The rates feasibility of screening and recruitment, rates of consent and retention, acceptability of outcome measures and the acceptability and fidelity of the intervention, were evaluated. Methods: Participants with stroke were recruited from hospital databases and community services and randomly assigned to the Regaining Confidence after Stroke (RCAS) course or usual care. The course comprised 11 weekly 2 hour sessions with 6-8 participants, delivered by two rehabilitation assistants. Carers were invited to attend three of the sessions. Sessions were video recorded. A six item checklist was developed from the manual content. Each item was rated as met, partially met, or not met. Fidelity was assumed if >75% of the criteria were met. Outcomes were assessed 3 and 6 months after randomisation. Semi-structured interviews, were conducted using open ended questions to assess the acceptability of the intervention. Results: Of 47 participants (mean age 66.9 years [SD 14.9]; 26 men) 22 were randomly allocated to the intervention and 25 to usual care. Participants attended a mean of 8.2 out of 11 sessions [SD 2.6]. Fidelity outcomes suggested that the content corresponded to the manual but further training of the therapist was needed. Interview findings indicated the intervention was acceptable and considered beneficial. At three months, 35 (78%) participants returned questionnaires and 30 (67%) at 6 months, but only 38(42 %) were fully completed. Conclusion: The results support the feasibility of conducting a randomised trial to evaluate the effectiveness of a RCAS course compared to usual care