<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/NCT02207023</url>
  </required_header>
  <id_info>
    <org_study_id>H13-03353</org_study_id>
    <nct_id>NCT02207023</nct_id>
  </id_info>
  <brief_title>Healthy Lifestyles After Stroke - Stroke Coach</brief_title>
  <acronym>StrokeCoach</acronym>
  <official_title>A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the efficacy of a lifestyle modification telehealth&#xD;
      program on health-related behaviours in community-dwelling individuals living with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants recruited in this study will be randomly assigned to either the Healthy&#xD;
      Lifestyle Training Program, or Attention Control Memory Training Program.&#xD;
&#xD;
      Individuals in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching&#xD;
      telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period.&#xD;
      Individuals in the Memory Training Program will each receive 7 memory coaching telephone&#xD;
      sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100&#xD;
      evaluable subjects will be recruited (124 to accommodate for 20% dropout).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)</measure>
    <time_frame>End of program (6 months)</time_frame>
    <description>The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily walking physical activity</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary behavior (26 items SmartDiet Questionnaire)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The SmartDiet Canadian Version Questionnaire was developed to assess fiber and fat intake. This questionnaire has 26 questions about diet and lifestyle. Most questions list foods in 3 or 4 categories according to fat or fiber content.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence (8-item Morisky Medication Adherence Scale)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The Morisky Medication Adherence Scale assesses habits in taking medication and barriers that may hinder medication adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition (Montreal Cognitive Assessment [MoCA])</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The MoCA is a screening instrument to assess for cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>These risk factors will be assessed using hospital lab services.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition (Body Mass Index, waist circumference)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The Body Mass Index is a measure of body fat based on weight and height. Waist circumference will be measured using a tape measure around the waist at the height of the umbilicus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (SF-36)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The SF-36 is a generic health status measure that was designed to be applied to all health conditions and assess health concepts, which represent basic human values and are relevant to a person's functional status and well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and Social Services Utilization (Health and Social Service Utilization Inventory)</measure>
    <time_frame>End of program (6 months), and 6 months after the program ends (12 months from baseline)</time_frame>
    <description>The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)</measure>
    <time_frame>6 months after the program ends (12 months from baseline)</time_frame>
    <description>The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Stroke</condition>
  <condition>Apoplexy</condition>
  <condition>Cerebral Stroke</condition>
  <condition>Cerebrovascular Accident</condition>
  <condition>Cerebrovascular Accident, Acute</condition>
  <condition>Cerebrovascular Apoplexy</condition>
  <condition>Cerebrovascular Stroke</condition>
  <condition>CVA</condition>
  <condition>Stroke, Acute</condition>
  <condition>Vascular Accident, Brain</condition>
  <arm_group>
    <arm_group_label>Memory Training Program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will participate in 7 memory training coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Lifestyle Training Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will participate in 7 lifestyle coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Lifestyle Training Program</intervention_name>
    <description>Study participants in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. The lifestyle coaches will work on a 1:1 basis with each participant to encourage healthy lifestyles.</description>
    <arm_group_label>Healthy Lifestyle Training Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has experienced a stroke in the last 12 months&#xD;
&#xD;
          -  50 years of age or older&#xD;
&#xD;
          -  Living in the community with phone access&#xD;
&#xD;
          -  Mild to moderate stroke severity (i.e., modified Rankin Scale score ranging from 1 to&#xD;
             4)&#xD;
&#xD;
          -  Able to communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke of non-vascular origin&#xD;
&#xD;
          -  Actively engaged in formal stroke rehabilitation services&#xD;
&#xD;
          -  Uncontrolled arrhythmias&#xD;
&#xD;
          -  Significant musculoskeletal or other neurological condition&#xD;
&#xD;
          -  Severe aphasia or dysarthria&#xD;
&#xD;
          -  Not medically stable&#xD;
&#xD;
          -  Pain or co-morbidities which would preclude activity&#xD;
&#xD;
          -  Living in long-term residential care&#xD;
&#xD;
          -  Cognitive impairment, dependent in activities of daily living, and no caregiver&#xD;
             participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janice Eng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Columbian Hospital</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Northern BC</name>
      <address>
        <city>Prince George</city>
        <state>British Columbia</state>
        <zip>V2M 1S2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surrey Memorial Hospital</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Family Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5P 3L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GF Strong Rehabilitation Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 5, 2020</last_update_submitted>
  <last_update_submitted_qc>May 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Janice Eng</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Stroke Coach</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Lifestyle behaviours</keyword>
  <keyword>Secondary prevention</keyword>
  <keyword>Chronic disease self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02207023
org study id: H13-03353
nct id: NCT02207023
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine the efficacy of a lifestyle modification telehealth
      program on health-related behaviours in community-dwelling individuals living with stroke.
Participants recruited in this study will be randomly assigned to either the Healthy
      Lifestyle Training Program, or Attention Control Memory Training Program.

      Individuals in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching
      telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period.
      Individuals in the Memory Training Program will each receive 7 memory coaching telephone
      sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100
      evaluable subjects will be recruited (124 to accommodate for 20% dropout).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
time frame: End of program (6 months)
description: The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.
measure: Daily walking physical activity
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: Study participants will wear the activity monitor over the 7 days following each assessment period (baseline, 6 months, 12 months)
measure: Dietary behavior (26 items SmartDiet Questionnaire)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The SmartDiet Canadian Version Questionnaire was developed to assess fiber and fat intake. This questionnaire has 26 questions about diet and lifestyle. Most questions list foods in 3 or 4 categories according to fat or fiber content.
measure: Medication adherence (8-item Morisky Medication Adherence Scale)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The Morisky Medication Adherence Scale assesses habits in taking medication and barriers that may hinder medication adherence.
measure: Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: This scale assess the frequency with which participants experience depression symptoms, such as restless sleep, poor appetite, and feeling lonely, during the past week.
measure: Cognition (Montreal Cognitive Assessment [MoCA])
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The MoCA is a screening instrument to assess for cognitive impairment.
measure: Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: These risk factors will be assessed using hospital lab services.
measure: Body composition (Body Mass Index, waist circumference)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The Body Mass Index is a measure of body fat based on weight and height. Waist circumference will be measured using a tape measure around the waist at the height of the umbilicus.
measure: Health-related quality of life (SF-36)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The SF-36 is a generic health status measure that was designed to be applied to all health conditions and assess health concepts, which represent basic human values and are relevant to a person's functional status and well-being.
measure: Health and Social Services Utilization (Health and Social Service Utilization Inventory)
time frame: End of program (6 months), and 6 months after the program ends (12 months from baseline)
description: The Health and Social Services Utilization inventory collects data regarding health services used, medications, and out of pocket health costs.
measure: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
time frame: 6 months after the program ends (12 months from baseline)
description: The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.
arm group label: Memory Training Program
arm group type: No Intervention
description: Participants will participate in 7 memory training coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.
arm group label: Healthy Lifestyle Training Program
arm group type: Experimental
description: Participants will participate in 7 lifestyle coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.
intervention type: Behavioral
intervention name: Healthy Lifestyle Training Program
description: Study participants in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. The lifestyle coaches will work on a 1:1 basis with each participant to encourage healthy lifestyles.
arm group label: Healthy Lifestyle Training Program
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Janice Eng, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Janice Eng
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: No