Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: A group psychosocial course

• Registration Number: NCT03807284
• Lead Sponsor: University of Nottingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-04-01
• Primary Completion: 2014-08-31
• Study Completion: 2016-08-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group psycho-social course	A group psychosocial course	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.

Primary Outcome Measures

Name	Time	Method
Number of participants recruited to the trial	One year recruitment period	Number of participants recruited to the trial
Number of participants who completed the trial	End of Study	Number of participants who completed the trial

Secondary Outcome Measures

Name	Time	Method
Coping	Baseline, 3 and 6 months follow up	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
Mood	Baseline, 3 and 6 months follow up	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.
Activity	Baseline, 3 and 6 months follow up	Nottingham Extended Activity of Daily Living Scale. A ranked self-assessment of important activities after following a stroke. Scale is ranked from 0-22.
Level of Confidence	Baseline, 3 and 6 months follow up	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.
Carers strain	Baseline, 3 and 6 months	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