<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03807284</url>
  </required_header>
  <id_info>
    <org_study_id>12061</org_study_id>
    <nct_id>NCT03807284</nct_id>
  </id_info>
  <brief_title>Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial</brief_title>
  <acronym>RCAS</acronym>
  <official_title>Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to&#xD;
      evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for&#xD;
      people with stroke discharged from rehabilitation, compared with usual care. The study also&#xD;
      aimed to evaluate the feasibility of improving mood and coping in carers of the course&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group&#xD;
      intervention that is designed to help stroke survivors when they have finished rehabilitation&#xD;
      to improve confidence in daily life. This feasibility study aimed to evaluate the&#xD;
      acceptability of the course in improving confidence, mood, adjustment and increasing activity&#xD;
      levels in stroke survivors as well as improving mood and coping in their carers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">August 31, 2016</completion_date>
  <primary_completion_date type="Actual">August 31, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome assessor was masked to the intervention until the outcomes were complete.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants recruited to the trial</measure>
    <time_frame>One year recruitment period</time_frame>
    <description>Number of participants recruited to the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who completed the trial</measure>
    <time_frame>End of Study</time_frame>
    <description>Number of participants who completed the trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Baseline, 3 and 6 months follow up</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity</measure>
    <time_frame>Baseline, 3 and 6 months follow up</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Confidence</measure>
    <time_frame>Baseline, 3 and 6 months follow up</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping</measure>
    <time_frame>Baseline, 3 and 6 months follow up</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carers strain</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>A group psycho-social course</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A group psychosocial course</intervention_name>
    <description>A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.</description>
    <arm_group_label>A group psycho-social course</arm_group_label>
    <other_name>Regaining Confidence After Stroke Course</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical diagnosis of stroke within two years&#xD;
&#xD;
          -  Discharged from all other rehabilitation therapies&#xD;
&#xD;
          -  Not involved in trials of other psychological interventions&#xD;
&#xD;
          -  Not previously attended an RCAS course&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Score of &lt;10 on the Barthel Index (sufficiently independent to cope in a group&#xD;
             setting)&#xD;
&#xD;
          -  Score &lt;8 on the Sheffield Screening test for Acquired Language Disorders so that&#xD;
             participants would be able to understand the materials being presented&#xD;
&#xD;
          -  Unable to speak English&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://eprints.nottingham.ac.uk/id/eprint/38848</url>
    <description>Regaining Confidence after Stroke - a feasibility study. MPhil KE Hooban</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Feasibility</keyword>
  <keyword>Confidence</keyword>
  <keyword>group intervention</keyword>
  <keyword>Psycho-social intervention</keyword>
  <keyword>Stroke recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03807284
org study id: 12061
nct id: NCT03807284
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcome assessor was masked to the intervention until the outcomes were complete.
measure: Number of participants recruited to the trial
time frame: One year recruitment period
description: Number of participants recruited to the trial
measure: Number of participants who completed the trial
time frame: End of Study
description: Number of participants who completed the trial
measure: Mood
time frame: Baseline, 3 and 6 months follow up
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.
measure: Activity
time frame: Baseline, 3 and 6 months follow up
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.
measure: Level of Confidence
time frame: Baseline, 3 and 6 months follow up
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.
measure: Coping
time frame: Baseline, 3 and 6 months follow up
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
measure: Carers strain
time frame: Baseline, 3 and 6 months
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
arm group label: A group psycho-social course
arm group type: Experimental
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 group label: Control Group
arm group type: No Intervention
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: A group psychosocial course
description: A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.
arm group label: A group psycho-social course
other name: Regaining Confidence After Stroke Course
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://eprints.nottingham.ac.uk/id/eprint/38848
description: Regaining Confidence after Stroke - a feasibility study. MPhil KE Hooban
responsible party type: Sponsor
mesh term: Stroke