Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: A group psychosocial course


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel group two arm feasiblity randomised controlled trial with 1:1 allocation in a single centre, comparing eleven week RCAS Course in addition to usual care, to usual care alone.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group psycho-social course<br>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. | Behavioral: A group psychosocial course<br>* A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.<br>* Other names: Regaining Confidence After Stroke Course;|
| No Intervention: Control Group<br>Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited to the trial | Number of participants recruited to the trial | One year recruitment period | 
| Number of participants who completed the trial | Number of participants who completed the trial | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | GHQ-30. Mood is measured using 30 questions, each with four response scores (0=better than usual) (1= about the same) (2 =Less well than usual) (3=Much less well than usual) maximum score is 90. | Baseline, 3 and 6 months follow up | 
| Activity | Nottingham Extended Activity of Daily Living Scale. A ranked self-assessment of important activities after following a stroke. Scale is ranked from 0-22. | Baseline, 3 and 6 months follow up | 
| Level of Confidence | A Confidence after Stroke (53 item) measure. This measure uses a Likert type format with four 'Likert type' responses, from zero to three depending on a positive or negative worded item. The highest achievable score of 159 indicating a high level of confidence. | Baseline, 3 and 6 months follow up | 
| Coping | The COPE inventory (Coping Orientation for Problem Orientated Experiences) a 60 question measure which asks how participants deal with stress and what they do in stressful events. The inventory has 15 domains and a maximum score of 16 is achievable. A high score indicates more frequent use of the described coping strategy | Baseline, 3 and 6 months follow up | 
| Carers strain | Carer Strain Index. The measure consists of 13 questions with yes or no answers. Highest score of 13 is achievable, where a high score indicates increased carer strain | Baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility, Confidence, group intervention, Psycho-social intervention, Stroke recovery