Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial (RCAS)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A group psychosocial course
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Feasibility, Confidence, group intervention, Psycho-social intervention, Stroke recovery
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A group psycho-social course
Control Group
Arm Description
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.
Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.
Outcomes
Primary Outcome Measures
Number of participants recruited to the trial
Number of participants recruited to the trial
Number of participants who completed the trial
Number of participants who completed the trial
Secondary Outcome Measures
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.
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.
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.
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
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
Full Information
NCT ID
NCT03807284
First Posted
January 10, 2019
Last Updated
January 23, 2019
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT03807284
Brief Title
Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial
Acronym
RCAS
Official Title
Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Feasibility, Confidence, group intervention, Psycho-social intervention, Stroke recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcome assessor was masked to the intervention until the outcomes were complete.
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A group psycho-social course
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.
Intervention Type
Behavioral
Intervention Name(s)
A group psychosocial course
Other Intervention Name(s)
Regaining Confidence After Stroke Course
Intervention Description
A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.
Primary Outcome Measure Information:
Title
Number of participants recruited to the trial
Description
Number of participants recruited to the trial
Time Frame
One year recruitment period
Title
Number of participants who completed the trial
Description
Number of participants who completed the trial
Time Frame
End of Study
Secondary Outcome Measure Information:
Title
Mood
Description
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.
Time Frame
Baseline, 3 and 6 months follow up
Title
Activity
Description
Nottingham Extended Activity of Daily Living Scale. A ranked self-assessment of important activities after following a stroke. Scale is ranked from 0-22.
Time Frame
Baseline, 3 and 6 months follow up
Title
Level of Confidence
Description
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.
Time Frame
Baseline, 3 and 6 months follow up
Title
Coping
Description
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
Time Frame
Baseline, 3 and 6 months follow up
Title
Carers strain
Description
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
Time Frame
Baseline, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://eprints.nottingham.ac.uk/id/eprint/38848
Description
Regaining Confidence after Stroke - a feasibility study. MPhil KE Hooban
Learn more about this trial
Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial
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