<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/NCT03792061</url>
  </required_header>
  <id_info>
    <org_study_id>N201804055</org_study_id>
    <nct_id>NCT03792061</nct_id>
  </id_info>
  <brief_title>Enhancing Community Participation for Stroke Survivors With Cognitive Impairments</brief_title>
  <official_title>Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract&#xD;
&#xD;
      Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3&#xD;
      or more on the Executive Interview, 14-item version) will be randomly assigned to the&#xD;
      intervention group and the attention control group at a 1:1 ratio. Each session will be&#xD;
      around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions.&#xD;
&#xD;
      Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D),&#xD;
      Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC)&#xD;
      Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive&#xD;
      Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke&#xD;
      scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation&#xD;
      Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1),&#xD;
      post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month&#xD;
      follow-up (T5).&#xD;
&#xD;
      Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state&#xD;
      scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at&#xD;
      baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear&#xD;
      regression models and mixed-effects regression models.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will examine the efficacy of a newly developed intervention program, the&#xD;
      Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving&#xD;
      participation in productivity, social activities, and community among community-dwelling&#xD;
      people with cognitive impairments after stroke. The OPASS program were developed based on the&#xD;
      theoretical tenets of strategy training, with the goal of helping participants to set their&#xD;
      participation goals, identify barriers to their performance, develop strategies to address&#xD;
      these barriers, and generalize their learning through iterative practice. To examine the&#xD;
      efficacy of OPASS, the following objectives will be addressed in this study:&#xD;
&#xD;
        1. To examine whether, compared to a control group, participating in the OPASS program will&#xD;
           improve participation in productivity, social, and community domains in stroke survivors&#xD;
           with cognitive impairments;&#xD;
&#xD;
        2. To determine whether the changes in participation after the intervention is correlated&#xD;
           with changes in applied cognition, daily activities, executive functioning, and&#xD;
           self-efficacy.&#xD;
&#xD;
        3. To examine whether the intervention effect sustains at 3-, 6-, and 12-month following&#xD;
           the intervention.&#xD;
&#xD;
      To address this purpose, parallel-group randomized controlled trial will be implemented to&#xD;
      assess the efficacy of the OPASS program in comparison to the control group. An expected&#xD;
      sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient&#xD;
      rehabilitation services will be recruited from our collaborative sites in Northern Taiwan.&#xD;
      These participants will be randomly assigned to the intervention group and the attention&#xD;
      control group at a 1:1 ratio.&#xD;
&#xD;
      Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D),&#xD;
      Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC)&#xD;
      Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive&#xD;
      Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke&#xD;
      scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation&#xD;
      Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1),&#xD;
      post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month&#xD;
      follow-up (T5). Data will be analyzed using multiple linear regression models and&#xD;
      mixed-effects regression models. Of the recruited participants, 100 will recieve the fMRI&#xD;
      tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and&#xD;
      the anatomical structure scan) at baseline(T1), post-intervention(T2), and 12-month follow-up&#xD;
      (T5). Data will be analyzed using multiple linear regression models and mixed-effects&#xD;
      regression models.&#xD;
&#xD;
      Qualitative in-depth interviews with participants, caregivers, and therapists will be&#xD;
      conducted following the intervention. Data regarding the interviewees' experiences,&#xD;
      satisfaction, and their perceived effectiveness of the intervention will be collected.&#xD;
      Transcribed data will be coded by two independent coders and analyzed with thematic analysis&#xD;
      method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 13, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HEAL positive outlook questionnaire</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Strategies self-efficacy Scale (PS-SES)</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Strategies self-efficacy Scale (PS-SES)</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Strategies self-efficacy Scale (PS-SES)</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Strategies self-efficacy Scale (PS-SES)</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>From the first session to the last session of the study, up to 8 weeks</time_frame>
    <description>The COPM inquires the client to identify important goals in their daily life and rate their performance and satisfaction for each goal on a 10-point visual analog scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail-Making Test (TMT A and B)</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail-Making Test (TMT A and B)</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail-Making Test (TMT A and B)</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail-Making Test (TMT A and B)</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>From baseline to up to 6 weeks</time_frame>
    <description>MoCA Test allows people to quickly assess a patients cognitive health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>MoCA Test allows people to quickly assess a patients cognitive health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>MoCA Test allows people to quickly assess a patients cognitive health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>MoCA Test allows people to quickly assess a patients cognitive health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The National Institutes of Health Stroke scale (NIHSS)</measure>
    <time_frame>From baseline to 3-month, 6-month, and 12-month follow-ups</time_frame>
    <description>The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale (MRS)</measure>
    <time_frame>From baseline to 3-month, 6-month, and 12-month follow-ups</time_frame>
    <description>The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euro-QoL-5-Dimension (EQ-5D)</measure>
    <time_frame>From baseline to 3-month, 6-month, and 12-month follow-ups</time_frame>
    <description>The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative data</measure>
    <time_frame>After intervention, an average of 2 months</time_frame>
    <description>Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)</measure>
    <time_frame>From baseline to 3-month follow-up</time_frame>
    <description>The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)</measure>
    <time_frame>From baseline to 6-month follow-up</time_frame>
    <description>The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)</measure>
    <time_frame>From baseline to 12-month follow-up</time_frame>
    <description>The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Stroke</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Strategy Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strategy training is an activity intervention training approach developed based on the theoretical tenets of metacognitive training. The purpose of strategy training is to guide individuals to generate problem-solving skills to address challenges that they identify in daily activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reflective listening</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strategy Training</intervention_name>
    <description>This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.</description>
    <arm_group_label>Strategy Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 20 years and older&#xD;
&#xD;
          -  Has a diagnosis of stroke&#xD;
&#xD;
          -  Understand Mandarin&#xD;
&#xD;
          -  Has cognitive impairment (a score of 3 or more on the Executive Interview, 14-item&#xD;
             version)&#xD;
&#xD;
          -  Provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have severe aphasia&#xD;
&#xD;
          -  Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance&#xD;
             use, or other psychiatric disorders that may impede them from continually&#xD;
             participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng-Hang Chang, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Feng-Hang Chang, ScD</last_name>
    <phone>886-2-2736-1661</phone>
    <phone_ext>6573</phone_ext>
    <email>fhchang@tmu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Medical University-Shuang Ho Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsan-Hon Liou</last_name>
      <phone>886-2-2249-0088</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lu Lu</last_name>
      <phone>886-2-2312-3456</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng-Hang Chang</last_name>
      <phone>886-2-2736-1661</phone>
      <phone_ext>6573</phone_ext>
      <email>fhchang@tmu.edu.tw</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taipei Municipal Wan Fang Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yen-Nung Lin</last_name>
      <phone>886-2-2930-7930</phone>
      <phone_ext>1600</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Feng-Hang Chang</investigator_full_name>
    <investigator_title>Associate Professor, Graduate Institute of Injury Prevention and Control, Taipei Medical University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The IPD is not planned to be shared.</ipd_description>
  </patient_data>
  <!-- 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/NCT03792061
org study id: N201804055
nct id: NCT03792061
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Abstract

      Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3
      or more on the Executive Interview, 14-item version) will be randomly assigned to the
      intervention group and the attention control group at a 1:1 ratio. Each session will be
      around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions.

      Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D),
      Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC)
      Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive
      Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke
      scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation
      Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1),
      post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month
      follow-up (T5).

      Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state
      scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at
      baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear
      regression models and mixed-effects regression models.
The proposed study will examine the efficacy of a newly developed intervention program, the
      Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving
      participation in productivity, social activities, and community among community-dwelling
      people with cognitive impairments after stroke. The OPASS program were developed based on the
      theoretical tenets of strategy training, with the goal of helping participants to set their
      participation goals, identify barriers to their performance, develop strategies to address
      these barriers, and generalize their learning through iterative practice. To examine the
      efficacy of OPASS, the following objectives will be addressed in this study:

        1. To examine whether, compared to a control group, participating in the OPASS program will
           improve participation in productivity, social, and community domains in stroke survivors
           with cognitive impairments;

        2. To determine whether the changes in participation after the intervention is correlated
           with changes in applied cognition, daily activities, executive functioning, and
           self-efficacy.

        3. To examine whether the intervention effect sustains at 3-, 6-, and 12-month following
           the intervention.

      To address this purpose, parallel-group randomized controlled trial will be implemented to
      assess the efficacy of the OPASS program in comparison to the control group. An expected
      sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient
      rehabilitation services will be recruited from our collaborative sites in Northern Taiwan.
      These participants will be randomly assigned to the intervention group and the attention
      control group at a 1:1 ratio.

      Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D),
      Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC)
      Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive
      Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke
      scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation
      Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1),
      post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month
      follow-up (T5). Data will be analyzed using multiple linear regression models and
      mixed-effects regression models. Of the recruited participants, 100 will recieve the fMRI
      tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and
      the anatomical structure scan) at baseline(T1), post-intervention(T2), and 12-month follow-up
      (T5). Data will be analyzed using multiple linear regression models and mixed-effects
      regression models.

      Qualitative in-depth interviews with participants, caregivers, and therapists will be
      conducted following the intervention. Data regarding the interviewees' experiences,
      satisfaction, and their perceived effectiveness of the intervention will be collected.
      Transcribed data will be coded by two independent coders and analyzed with thematic analysis
      method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
time frame: From baseline to up to 6 weeks
description: The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
time frame: From baseline to up to 6 weeks
description: The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
time frame: From baseline to 3-month follow-up
description: The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
time frame: From baseline to 6-month follow-up
description: The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
measure: Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms
time frame: From baseline to 12-month follow-up
description: The AM-PAC consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
measure: HEAL positive outlook questionnaire
time frame: From baseline to up to 6 weeks
description: he HEAL positive outlook questionnaire will be used to assess participant's positive attitude.
measure: Participation Strategies self-efficacy Scale (PS-SES)
time frame: From baseline to up to 6 weeks
description: The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
measure: Participation Strategies self-efficacy Scale (PS-SES)
time frame: From baseline to 3-month follow-up
description: The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
measure: Participation Strategies self-efficacy Scale (PS-SES)
time frame: From baseline to 6-month follow-up
description: The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
measure: Participation Strategies self-efficacy Scale (PS-SES)
time frame: From baseline to 12-month follow-up
description: The PSSES was developed to measure self-efficacy in managing home participation, community participation, productivity, communication, staying organized, and advocating for resources. The scale consists of 35 items. Each item is rated using a 1-10 Likert scale, with higher score indicating greater self-efficacy.
measure: Canadian Occupational Performance Measure (COPM)
time frame: From the first session to the last session of the study, up to 8 weeks
description: The COPM inquires the client to identify important goals in their daily life and rate their performance and satisfaction for each goal on a 10-point visual analog scale.
measure: Stroop Test
time frame: From baseline to up to 6 weeks
description: Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
measure: Stroop Test
time frame: From baseline to 3-month follow-up
description: Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
measure: Stroop Test
time frame: From baseline to 6-month follow-up
description: Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
measure: Stroop Test
time frame: From baseline to 12-month follow-up
description: Participants will be asked to read out the ink color of the word as accurately and as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded. Construct validity of the Stroop Test in the TBI population has been published.
measure: Trail-Making Test (TMT A and B)
time frame: From baseline to up to 6 weeks
description: Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
measure: Trail-Making Test (TMT A and B)
time frame: From baseline to 3-month follow-up
description: Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
measure: Trail-Making Test (TMT A and B)
time frame: From baseline to 6-month follow-up
description: Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
measure: Trail-Making Test (TMT A and B)
time frame: From baseline to 12-month follow-up
description: Trail-Making Test (TMT A and B) will be used to measure sustained attention, sequencing, mental flexibility, and visual tracking. TMT-A requires the individual to link in an ascending order a series of 25 numbered circles distributed randomly on a test paper as quickly as possible. TMT-B is similar, although it requires the individual to link switching alternatively between a set of numbers (1-13) and a set of letters (A-L) in an ascending order (1-A-2-B-3-C...). The Time to complete TMT A and B will be calculated, in which a longer completion time will indicate poorer outcome. This instrument was validated in healthy people, patients with head injury, vascular disorders, and other diverse populations.
measure: Montreal Cognitive Assessment (MoCA)
time frame: From baseline to up to 6 weeks
description: MoCA Test allows people to quickly assess a patients cognitive health.
measure: Montreal Cognitive Assessment (MoCA)
time frame: From baseline to 3-month follow-up
description: MoCA Test allows people to quickly assess a patients cognitive health.
measure: Montreal Cognitive Assessment (MoCA)
time frame: From baseline to 6-month follow-up
description: MoCA Test allows people to quickly assess a patients cognitive health.
measure: Montreal Cognitive Assessment (MoCA)
time frame: From baseline to 12-month follow-up
description: MoCA Test allows people to quickly assess a patients cognitive health.
measure: The National Institutes of Health Stroke scale (NIHSS)
time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
description: The National Institutes of Health Stroke scale (NIHSS) will be used to assess participant's health related quality of life.
measure: modified Rankin Scale (MRS)
time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
description: The modified Rankin Scale (MRS) will be used to assess participant's health related quality of life.
measure: Euro-QoL-5-Dimension (EQ-5D)
time frame: From baseline to 3-month, 6-month, and 12-month follow-ups
description: The Euro-QoL-5-Dimension (EQ-5D) will be used to assess participant's health related quality of life.
measure: Qualitative data
time frame: After intervention, an average of 2 months
description: Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected.
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
time frame: From baseline to 3-month follow-up
description: The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
time frame: From baseline to 6-month follow-up
description: The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
time frame: From baseline to 12-month follow-up
description: The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
arm group label: Strategy Training
arm group type: Experimental
description: Strategy training is an activity intervention training approach developed based on the theoretical tenets of metacognitive training. The purpose of strategy training is to guide individuals to generate problem-solving skills to address challenges that they identify in daily activities.
arm group label: Reflective listening
arm group type: No Intervention
description: Participants in the control group will receive dose-matched non-active intervention carried out by a trained research staff. The staff will use scripted questions to provoke participants to describe their experiences and feelings about their disease and their usual-care rehabilitation activities.
intervention type: Behavioral
intervention name: Strategy Training
description: This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.
arm group label: Strategy Training
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Feng-Hang Chang, ScD
role: Principal Investigator
affiliation: Taipei Medical University
last name: Feng-Hang Chang, ScD
phone: 886-2-2736-1661
phone ext: 6573
email: fhchang@tmu.edu.tw
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Feng-Hang Chang
investigator title: Associate Professor, Graduate Institute of Injury Prevention and Control, Taipei Medical University
mesh term: Stroke
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: The IPD is not planned to be shared.