<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/NCT02977624</url>
  </required_header>
  <id_info>
    <org_study_id>0689-15-HMO</org_study_id>
    <nct_id>NCT02977624</nct_id>
  </id_info>
  <brief_title>A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury</brief_title>
  <official_title>Effectiveness of a Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <brief_summary>
    <textblock>
      Objectives - To evaluate the effectiveness of an telerehabilitation intervention program&#xD;
      among acquired brain injury (ABI) survivors in the chronic phase. The aim of the intervention&#xD;
      is to improve the transition from rehabilitation units to community dwelling and facilitate&#xD;
      activity and participation in life roles in the community.&#xD;
&#xD;
      Working hypothesis - The telerehabilitation based program for ABI survivors will be effective&#xD;
      in:&#xD;
&#xD;
        1. Improving function in activities of daily living, participation in occupations and&#xD;
           health related quality of life.&#xD;
&#xD;
        2. Reducing the need for outpatient clinic and rehabilitation services.&#xD;
&#xD;
        3. The intervention achievements will be maintained in 3-month follow-up&#xD;
&#xD;
      Methodology - Participants: ABI survivors will be selected from patients who are referred to&#xD;
      the outpatient or home-based rehabilitation unit of Maccabi health services. Following&#xD;
      completion of out-patient occupational therapy treatment in the rehabilitation centers the&#xD;
      participants will be randomly assigned into two groups: The treatment group will receive the&#xD;
      intervention program in addition to standard care, and the waitlist control group will&#xD;
      receive standard care only.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
        1. The Canadian Occupational Performance Measure (COPM)&#xD;
&#xD;
        2. The Performance Quality Rating Scale (PQRS)&#xD;
&#xD;
        3. Mayo-Portland Adaptability Inventory (MPAI-4)&#xD;
&#xD;
        4. The Dysexecutive Questionnaire (DEX)&#xD;
&#xD;
        5. The New General Self-Efficacy Scale (NGSE)&#xD;
&#xD;
        6. The Zarit Caregiver Burden Scale short version&#xD;
&#xD;
      Procedure: The intervention program includes up to 20 video sessions over 3 months between an&#xD;
      occupational therapist and the participant. The virtual meetings will be conducted using The&#xD;
      Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on&#xD;
      problem solving for daily life situations and on the ability to implement the discussed&#xD;
      strategies for a variety of activities. Participants will be evaluated at baseline, after the&#xD;
      intervention, and after 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention program includes up to 20 video sessions over 3 months between an&#xD;
      occupational therapist and the participant. The virtual meetings will be conducted using The&#xD;
      Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on&#xD;
      problem solving for daily life situations and on the ability to implement the discussed&#xD;
      strategies for a variety of activities. Participants will be evaluated at baseline, after the&#xD;
      intervention, and after 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>The COPM is a semi-structured interview to facilitate client-centered goal setting and measure the client's perceived occupational performance and satisfaction levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Performance Quality Rating Scale (PQRS)</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>The PQRS is an observational measure of activity performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Mayo-Portland Adaptability Inventory (MPAI-4)</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>The MPAI-4 measures the recovery progress of people after an ABI and includes 29 items grouped into three subscales: (a) Ability (e.g., motor, sensory and cognitive abilities), (b) Adaptation (e.g., emotional state and social interactions), and (c) Participation (e.g., leisure activities, employment and transportation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Dysexecutive Questionnaire (DEX)</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The New General Self-Efficacy Scale (NGSE)</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>This is an 8-item questionnaire that assesses people's confidence in their ability to accomplish their goals, regardless of the obstacles they may face</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Short Form Zarit Burden Interview</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>A measure of caregiver burden</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction questionnaire</measure>
    <time_frame>Post intervention</time_frame>
    <description>A measure of the participants' satisfaction with the tele-CO-OP intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Background questionnaire</measure>
    <time_frame>6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)</time_frame>
    <description>A questionnaire to document sociodemographic and clinical characteristics</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Brain Injury, Chronic</condition>
  <arm_group>
    <arm_group_label>Tele-CO-OP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention included weekly videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP) over a period of three months. Participant identified five functional goals, of which three were directly addressed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The waitlist control group did not receive the intervention during the same time period</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Cognitive Orientation to daily Occupational Performance</intervention_name>
    <arm_group_label>Tele-CO-OP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) ≥ 6 months post-ABI; (2) age ≥ 18 years; (3) sufficient proficiency in Hebrew or&#xD;
        English to participate in the study; (4) modified Rankin scale (mRS) scores of 2-4&#xD;
        reflecting slight to moderate disability [38]; (5) self-reported unmet functional goals;&#xD;
        (6) internet access at home; and (7) had an adult significant other who agreed to be&#xD;
        involved in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) moderate or severe aphasia; (2) a score of &lt;21 on the Mini Mental Status Examination&#xD;
        (MMSE) or Montreal Cognitive Assessment scores: MOCA&lt;19; (3) dementia diagnosis; (3) an&#xD;
        acute illness which significantly impacts the ability to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injury, Chronic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02977624
org study id: 0689-15-HMO
nct id: NCT02977624
lead sponsor: 
Objectives - To evaluate the effectiveness of an telerehabilitation intervention program
      among acquired brain injury (ABI) survivors in the chronic phase. The aim of the intervention
      is to improve the transition from rehabilitation units to community dwelling and facilitate
      activity and participation in life roles in the community.

      Working hypothesis - The telerehabilitation based program for ABI survivors will be effective
      in:

        1. Improving function in activities of daily living, participation in occupations and
           health related quality of life.

        2. Reducing the need for outpatient clinic and rehabilitation services.

        3. The intervention achievements will be maintained in 3-month follow-up

      Methodology - Participants: ABI survivors will be selected from patients who are referred to
      the outpatient or home-based rehabilitation unit of Maccabi health services. Following
      completion of out-patient occupational therapy treatment in the rehabilitation centers the
      participants will be randomly assigned into two groups: The treatment group will receive the
      intervention program in addition to standard care, and the waitlist control group will
      receive standard care only.

      Outcome measures:

        1. The Canadian Occupational Performance Measure (COPM)

        2. The Performance Quality Rating Scale (PQRS)

        3. Mayo-Portland Adaptability Inventory (MPAI-4)

        4. The Dysexecutive Questionnaire (DEX)

        5. The New General Self-Efficacy Scale (NGSE)

        6. The Zarit Caregiver Burden Scale short version

      Procedure: The intervention program includes up to 20 video sessions over 3 months between an
      occupational therapist and the participant. The virtual meetings will be conducted using The
      Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on
      problem solving for daily life situations and on the ability to implement the discussed
      strategies for a variety of activities. Participants will be evaluated at baseline, after the
      intervention, and after 6 months.
The intervention program includes up to 20 video sessions over 3 months between an
      occupational therapist and the participant. The virtual meetings will be conducted using The
      Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on
      problem solving for daily life situations and on the ability to implement the discussed
      strategies for a variety of activities. Participants will be evaluated at baseline, after the
      intervention, and after 6 months.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
primary purpose: Treatment
masking: None (Open Label)
measure: The Canadian Occupational Performance Measure (COPM)
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: The COPM is a semi-structured interview to facilitate client-centered goal setting and measure the client's perceived occupational performance and satisfaction levels.
measure: The Performance Quality Rating Scale (PQRS)
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: The PQRS is an observational measure of activity performance.
measure: The Mayo-Portland Adaptability Inventory (MPAI-4)
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: The MPAI-4 measures the recovery progress of people after an ABI and includes 29 items grouped into three subscales: (a) Ability (e.g., motor, sensory and cognitive abilities), (b) Adaptation (e.g., emotional state and social interactions), and (c) Participation (e.g., leisure activities, employment and transportation).
measure: The Dysexecutive Questionnaire (DEX)
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI
measure: The New General Self-Efficacy Scale (NGSE)
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: This is an 8-item questionnaire that assesses people's confidence in their ability to accomplish their goals, regardless of the obstacles they may face
measure: the Short Form Zarit Burden Interview
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: A measure of caregiver burden
measure: Satisfaction questionnaire
time frame: Post intervention
description: A measure of the participants' satisfaction with the tele-CO-OP intervention
measure: Background questionnaire
time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
description: A questionnaire to document sociodemographic and clinical characteristics
arm group label: Tele-CO-OP
arm group type: Experimental
description: The intervention included weekly videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP) over a period of three months. Participant identified five functional goals, of which three were directly addressed.
arm group label: Waitlist control
arm group type: No Intervention
description: The waitlist control group did not receive the intervention during the same time period
intervention type: Behavioral
intervention name: The Cognitive Orientation to daily Occupational Performance
arm group label: Tele-CO-OP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injury, Chronic
mesh term: Wounds and Injuries