Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

Stroke Clinical Trial

— RCAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807284
• Other study ID #: 12061
• Status: Completed
• Phase: N/A
• Start date: April 1, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: January 2019
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• A group psychosocial course
A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited to the trial	Number of participants recruited to the trial	One year recruitment period
Primary	Number of participants who completed the trial	Number of participants who completed the trial	End of Study
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Regaining Confidence after Stroke - a feasibility study. MPhil KE Hooban