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Completed

NCT Number: NCT03807284

Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A group psychosocial course

Behavioral

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

Primary outcomes

  1. Number of participants recruited to the trial

    Time frame: One year recruitment period

    Number of participants recruited to the trial

  2. Number of participants who completed the trial

    Time frame: End of Study

    Number of participants who completed the trial

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Acronym: RCAS

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Jan 16, 2019
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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