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临床试验/NCT03807284
NCT03807284已完成不适用

Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.

University of Nottingham0 个研究点目标入组 51 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
主要终点
Number of participants who completed the trial

研究概览

简要总结

The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.

详细描述

The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. This feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor was masked to the intervention until the outcomes were complete.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •A clinical diagnosis of stroke within two years
  • •Discharged from all other rehabilitation therapies
  • •Not involved in trials of other psychological interventions
  • •Not previously attended an RCAS course

排除标准

  • •Score of <10 on the Barthel Index (sufficiently independent to cope in a group setting)
  • •Score <8 on the Sheffield Screening test for Acquired Language Disorders so that participants would be able to understand the materials being presented
  • •Unable to speak English
  • •Unable to give informed consent

研究组 & 干预措施

A group psycho-social course

Experimental

The intervention group received a group psycho-social course, a 2 hour, weekly, eleven week intervention delivered by a health professional working in stroke and usual care.

干预措施: A group psychosocial course (Behavioral)

Control Group

No Intervention

Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.

结局指标

主要结局

Number of participants who completed the trial

时间窗: End of Study

Number of participants who completed the trial

Number of participants recruited to the trial

时间窗: One year recruitment period

Number of participants recruited to the trial

次要结局

  • Mood(Baseline, 3 and 6 months follow up)
  • Activity(Baseline, 3 and 6 months follow up)
  • Coping(Baseline, 3 and 6 months follow up)
  • Level of Confidence(Baseline, 3 and 6 months follow up)
  • Carers strain(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

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