<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/NCT03286010</url>
  </required_header>
  <id_info>
    <org_study_id>20170613-01H</org_study_id>
    <nct_id>NCT03286010</nct_id>
  </id_info>
  <brief_title>Peer Support for Women With Heart Disease: Women@Heart</brief_title>
  <official_title>Cluster Randomization Trial of Peer Support for Women With Heart Disease: Women@ Heart</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</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>
      Women with heart disease are more likely to die or suffer another cardiac event or stroke&#xD;
      within 5 years of an index event compared to men. They are also more likely to suffer&#xD;
      depression and report lower quality of life. Cardiac Rehabilitation programs have been&#xD;
      designed to address these issues, but most women do not attend. Women indicate they have a&#xD;
      greater need to talk about their experiences with heart disease and seek social support to&#xD;
      help them cope. Peer support, the assistance provided by other women with a similar illness&#xD;
      experience, may be one way to enhance social support for women with heart disease and help&#xD;
      them improve their psychosocial well-being. The Investigators have developed a peer support&#xD;
      program called Women@Heart (W@H). The program is led by trained peer leaders (women who&#xD;
      themselves have made a successful recovery from a heart event). A pilot test of the program&#xD;
      showed promising results. The Investigators now need to conduct a more rigorous evaluation of&#xD;
      the program.&#xD;
&#xD;
      The main objective of this project is to determine if the W@H program helps women to improve&#xD;
      their psychosocial well-being compared to being on a waiting list to participate in the&#xD;
      program. It will also examine the effect of the program on: health behaviours (tobacco&#xD;
      smoking, physical activity, sedentary behaviour, fruit and vegetable consumption, and&#xD;
      medication adherence); coronary risk factors; and clinical outcomes (re-hospitalization,&#xD;
      health care system use, death).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychosocial well-being as measured by a total composite score</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>The composite score will combine data from seven measures (ESSI, BCI, BAI, BDI2, MCS, HeartQol and PSS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking Status</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Measured by self report and carbon monoxide breath test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fruit/Vegetable consumption</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menstrual Status</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender Role Identity</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>The BEM Sex Role Inventory will be used to assess participants' feelings towards their own gender role identities (masculine, feminine, androgynous and undifferentiated).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Measured through self reported physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salt Consumption</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>Baseline to week 26 follow up</time_frame>
    <description>Assessed through two questions asking whether or not participants ever forget to take their medication and if they ever stop taking their medication (if so why).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Coronary Heart Disease</condition>
  <condition>Women's Health</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the W@H group will be assembled in small groups of 6-12 participants and attend 12-biweekly sessions over a 24-week intervention period. The sessions will be led by a trained peer leader and will be held in a variety of convenient locations in close geographic proximity to participants' home postal codes. Participants will receive a manual containing copies of learning exercises and educational material. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will be eligible to participate in the study, but cannot participate because there are no groups within their geographical region. They will be offered the W@H program after their 26-week follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Women@Heart Program</intervention_name>
    <description>The Women@Heart program is taught by trained peer leaders. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention). In total there are 12-biweekly sessions offered over a 24-week period.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women who have been hospitalized at UOHI in the past year with stable CHD, including:&#xD;
             AMI; stable angina with corroborating evidence of CHD; recent CABG; or percutaneous&#xD;
             coronary intervention (to allow examination of mechanisms linking the intervention and&#xD;
             psychosocial well-being with health and healthcare outcomes);&#xD;
&#xD;
          2. Women ≥ 18 years of age (the age of consent in Ontario);&#xD;
&#xD;
          3. Women able to read and understand English or French;&#xD;
&#xD;
          4. Women who reside in Ontario and are eligible for Ontario Health Insurance Plan (to&#xD;
             permit linkage with administrative data housed at the Institute for Clinical&#xD;
             Evaluative Sciences [ICES]);&#xD;
&#xD;
          5. Women available to participate over the next 6 months (the intervention and data&#xD;
             collection takes place over this time frame -- reducing the probability of missing&#xD;
             data);&#xD;
&#xD;
          6. Women able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who have been hospitalized primarily for valve replacement or repair, HF,&#xD;
             pulmonary hypertension, endocarditis or pericarditis (to reduce heterogeneity and&#xD;
             avoid confounding when examining mechanisms linking the intervention and psychosocial&#xD;
             well-being with health and healthcare outcomes);&#xD;
&#xD;
          2. Women who, in the opinion of the UOHI clinical psychologist, manifest psychiatric&#xD;
             illness or cognitive impairment that would preclude participation in W@H (i.e. they&#xD;
             are unable to benefit from the intervention, to prevent disruption of other&#xD;
             participants).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri Mullen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Evyanne Wooding</last_name>
    <phone>613-696-7000</phone>
    <phone_ext>17596</phone_ext>
    <email>ewooding@ottawaheart.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4M2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evyanne Wooding</last_name>
      <phone>613-696-7000</phone>
      <phone_ext>17596</phone_ext>
      <email>ewooding@ottawaheart.ca</email>
    </contact>
    <contact_backup>
      <last_name>Nia Patel, MSc</last_name>
      <phone>613-696-7000</phone>
      <phone_ext>17595</phone_ext>
      <email>niapatel@ottawaheart.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Kerri-Anne Mullen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</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>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</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/NCT03286010
org study id: 20170613-01H
nct id: NCT03286010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women with heart disease are more likely to die or suffer another cardiac event or stroke
      within 5 years of an index event compared to men. They are also more likely to suffer
      depression and report lower quality of life. Cardiac Rehabilitation programs have been
      designed to address these issues, but most women do not attend. Women indicate they have a
      greater need to talk about their experiences with heart disease and seek social support to
      help them cope. Peer support, the assistance provided by other women with a similar illness
      experience, may be one way to enhance social support for women with heart disease and help
      them improve their psychosocial well-being. The Investigators have developed a peer support
      program called Women@Heart (W@H). The program is led by trained peer leaders (women who
      themselves have made a successful recovery from a heart event). A pilot test of the program
      showed promising results. The Investigators now need to conduct a more rigorous evaluation of
      the program.

      The main objective of this project is to determine if the W@H program helps women to improve
      their psychosocial well-being compared to being on a waiting list to participate in the
      program. It will also examine the effect of the program on: health behaviours (tobacco
      smoking, physical activity, sedentary behaviour, fruit and vegetable consumption, and
      medication adherence); coronary risk factors; and clinical outcomes (re-hospitalization,
      health care system use, death).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Psychosocial well-being as measured by a total composite score
time frame: Baseline to week 26 follow up
description: The composite score will combine data from seven measures (ESSI, BCI, BAI, BDI2, MCS, HeartQol and PSS)
measure: Smoking Status
time frame: Baseline to week 26 follow up
description: Measured by self report and carbon monoxide breath test
measure: Fruit/Vegetable consumption
time frame: Baseline to week 26 follow up
description: Measured by two questions from the Ontario Health Study that assess typical daily servings of fruits and vegetables.
measure: Menstrual Status
time frame: Baseline to week 26 follow up
description: Measured through self reported menstrual status (i.e., pre, peri or post-menopausal)
measure: Gender Role Identity
time frame: Baseline to week 26 follow up
description: The BEM Sex Role Inventory will be used to assess participants' feelings towards their own gender role identities (masculine, feminine, androgynous and undifferentiated).
measure: Physical Activity
time frame: Baseline to week 26 follow up
description: Measured through self reported physical activity
measure: Salt Consumption
time frame: Baseline to week 26 follow up
description: Assessed using 1 question from the Canadian Community Health Survey (2015) that assess weekly intake of salty foods.
measure: Medication Adherence
time frame: Baseline to week 26 follow up
description: Assessed through two questions asking whether or not participants ever forget to take their medication and if they ever stop taking their medication (if so why).
arm group label: Intervention
arm group type: Experimental
description: Participants in the W@H group will be assembled in small groups of 6-12 participants and attend 12-biweekly sessions over a 24-week intervention period. The sessions will be led by a trained peer leader and will be held in a variety of convenient locations in close geographic proximity to participants' home postal codes. Participants will receive a manual containing copies of learning exercises and educational material. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention).
arm group label: Control
arm group type: No Intervention
description: Participants in the control group will be eligible to participate in the study, but cannot participate because there are no groups within their geographical region. They will be offered the W@H program after their 26-week follow up.
intervention type: Behavioral
intervention name: Women@Heart Program
description: The Women@Heart program is taught by trained peer leaders. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention). In total there are 12-biweekly sessions offered over a 24-week period.
arm group label: Intervention
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kerri Mullen
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
last name: Evyanne Wooding
phone: 613-696-7000
phone ext: 17596
email: ewooding@ottawaheart.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: No