search
Back to results

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
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 10, 2019
    Last Updated
    January 23, 2019
    Sponsor
    University of Nottingham
    Collaborators
    National Institute for Health Research, United Kingdom
    search

    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

    We'll reach out to this number within 24 hrs