Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial (RCAS)

January 23, 2019 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group psycho-social 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.
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.
Other Names:
  • Regaining Confidence After Stroke Course
No Intervention: Control Group
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: 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.
Baseline, 3 and 6 months follow up
Activity
Time Frame: 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.
Baseline, 3 and 6 months follow up
Level of Confidence
Time Frame: 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.
Baseline, 3 and 6 months follow up
Coping
Time Frame: 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
Baseline, 3 and 6 months follow up
Carers strain
Time Frame: 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
Baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

National Institute for Health Research, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

August 31, 2014

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12061 (Registry Identifier: DAIDS-ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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