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

Horne, Jane C.; Hooban, Kate E.; Lincoln, Nadina B.; Logan, Pip

Authors

Jane C. Horne

Kate E. Hooban

Nadina B. Lincoln

PIP LOGAN pip.logan@nottingham.ac.uk
Professor of Rehabilitation Research



Abstract

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.

Citation

Horne, J. C., Hooban, K. E., Lincoln, N. B., & Logan, P. (2019). Regaining Confidence after Stroke (RCAS): a feasibility randomised controlled trial (RCT). Pilot and Feasibility Studies, 5, 1-12. https://doi.org/10.1186/s40814-019-0480-z

Journal Article Type Article
Acceptance Date Jun 15, 2019
Online Publication Date Jul 25, 2019
Publication Date Jul 25, 2019
Deposit Date Jun 20, 2019
Publicly Available Date Mar 28, 2024
Journal Pilot and Feasibility Studies
Electronic ISSN 2055-5784
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 5
Article Number 96
Pages 1-12
DOI https://doi.org/10.1186/s40814-019-0480-z
Keywords Feasibility, Confidence, Stroke, Psychological therapies, Group intervention
Public URL https://nottingham-repository.worktribe.com/output/2213923
Publisher URL https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0480-z
Additional Information Received: 25 January 2019; Accepted: 9 July 2019; First Online: 25 July 2019; : Ethical approval was gained from the National Research Ethics Service (NRES), East Midlands-Nottingham 1 (12/EM/0319). Procedures that adhered to Good Clinical Practice (GCP) received favourable approval to consent to participate in the trial in 2011.; : Not applicable; : The authors declare that they have no competing interests.

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