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Regaining Confidence after Stroke (RCAS): a feasibility randomised controlled trial (RCT)
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2019-07-25 , DOI: 10.1186/s40814-019-0480-z
Jane C Horne 1 , Kate E Hooban 1 , Nadina B Lincoln 1 , Pip A Logan 1
Affiliation  

The Regaining Confidence after Stroke (RCAS) course 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. 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-h sessions with six–eight 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 three and six months after randomisation. Semi-structured interviews were conducted using open-ended questions to assess the acceptability of the intervention. 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 [SD 2.6] out of 11 sessions. 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 six months, but only 38(42%) were fully completed. The results support the feasibility of conducting a randomised trial to evaluate the effectiveness of a RCAS course compared to usual care. ISRCTN 36330958

中文翻译:

中风后重拾信心 (RCAS):一项可行性随机对照试验 (RCT)

中风后恢复信心 (RCAS) 课程旨在促进康复出院的中风患者的调整。该试验的目的是评估进行随机试验以比较 RCAS 课程与常规护理的可行性。评估筛选和招募率的可行性、同意率和保留率、结果测量的可接受性以及干预的可接受性和保真度。从医院数据库和社区服务中招募患有中风的参与者,并随机分配到中风后恢复信心(RCAS)课程或常规护理。该课程包括 11 次每周 2 小时的课程,有 6 到 8 名参与者,由两名康复助理授课。照顾者被邀请参加其中的三个会议。会议是视频录制的。根据手册内容制定了六项清单。每个项目被评为满足、部分满足或未满足。如果满足> 75%的标准,则假定保真度。随机分组后 3 个月和 6 个月评估结果。使用开放式问题进行半结构化访谈,以评估干预的可接受性。在 47 名参与者(平均年龄 66.9 岁 [SD 14.9];26 名男性)中,22 名被随机分配到干预组,25 名被随机分配到常规护理组。在 11 次会议中,参与者平均参加了 8.2 [SD 2.6]。保真度结果表明内容与手册相符,但需要对治疗师进行进一步培训。访谈结果表明干预是可以接受的并且被认为是有益的。三个月时,有 35 名 (78%) 参与者返回问卷,六个月时有 30 名 (67%) 但只有 38 个(42%)完全完成。结果支持进行随机试验以评估 RCAS 课程与常规护理相比的有效性的可行性。ISRCTN 36330958
更新日期:2019-07-25
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