xml: <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/NCT06025721</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-FY2022-373</org_study_id>
      <secondary_id>P50MD017342</secondary_id>
      <nct_id>NCT06025721</nct_id>
    </id_info>
    <brief_title>Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness</brief_title>
    <acronym>CV-Homes</acronym>
    <official_title>Development of a Multiple Health Behavior Change Intervention for Cardiovascular Risk Reduction Among People Experiencing Homelessness: The CV-HOMES Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hennepin Healthcare Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Hennepin Healthcare Research Institute</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>
        This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing&#xD;
        Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of&#xD;
        anticipated study procedures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is of a set of studies with an overall goal to develop and pilot test a&#xD;
        collaborative care intervention using motivational interviewing and behavioral activation&#xD;
        alongside education and psychosocial support to improve medication adherence tailored to the&#xD;
        experiences of people experiencing homelessness and cardiovascular health risks (CV-H). Our&#xD;
        team's central hypothesis is that medication adherence and cardiovascular self-care (and&#xD;
        eventual glycemic control, cholesterol control, health care use/cost) will improve with an&#xD;
        intervention tailored to the unique context of CV-H.&#xD;
  &#xD;
        This protocol addresses a pilot study to test patient perceptions of the feasibility and&#xD;
        acceptability of study procedures and refine the CV-Homes treatment manual through test cases&#xD;
        (n=8). With a hypothesis that the CV-Homes manual and study procedures will be feasible and&#xD;
        acceptable to CV-H as measured by self-report and post-treatment interview.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">February 23, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 23, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This will be an in-person, phone, or video based behavioral intervention. It will involve a wellness coach assisting participants to set goals related to diabetes self-care and co-morbitities or social conditions that get in the way of health and wellness. There will be encouragement to work on medication adherence and to address getting healthy sleep, quitting tobacco, being more active, and eating better.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability Measured by the Client Satisfaction Questionnaire</measure>
      <time_frame>at 16 weeks</time_frame>
      <description>This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire, with a score range 8-32, higher score indicating greater satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Engagement Measured by Sessions Attended</measure>
      <time_frame>At 16 weeks</time_frame>
      <description>Throughout the study we will measure engagement by tracking attendance of treatment sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>Baseline to 16 weeks</time_frame>
      <description>Health related quality of life as measured by the Euro-Qol 5D-5-L which asks 5 questions on a 5-response likert scale with 1 = no problems and 5= unable to; and one question on a scale of 1-100 with 1 being the worst health one can imagine and 100 being the best health one can imagine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c</measure>
      <time_frame>Baseline to 16 weeks</time_frame>
      <description>Change in point-of-care hemoglobin A1c</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol</measure>
      <time_frame>Baseline to 16 weeks</time_frame>
      <description>Change in point-of-care cholesterol</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Heart Diseases</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Pre-diabetes</condition>
    <condition>Hypertension</condition>
    <condition>Hyperlipidemias</condition>
    <arm_group>
      <arm_group_label>CV-Homes Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral treatment by a wellness coach.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cardiovascular Risk Homeless Support</intervention_name>
      <description>There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve cardiovascular care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief cardiovascular health education as needed.</description>
      <arm_group_label>CV-Homes Intervention</arm_group_label>
      <other_name>CV-Homes</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 yrs. or older&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  Homelessness by federal definition in the last 12 mo.&#xD;
  &#xD;
            -  Self-reported diagnosis of moderate or high CVD risk, defined as being told by a&#xD;
               medical professional that the participant has hypertension, prediabetes, type 2&#xD;
               diabetes, or heart disease&#xD;
  &#xD;
            -  Plan to stay in local area or be reachable by phone for the next 16 weeks&#xD;
  &#xD;
            -  Willingness to work on one or more CVD risk reduction behavior change&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active intoxication&#xD;
  &#xD;
            -  Active psychosis&#xD;
  &#xD;
            -  Presence of a legal guardian&#xD;
  &#xD;
            -  Pregnant or lactating people&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katherine D Vickery, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hennepin Healthcare Research Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hennepin Healthcare Research Institute</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiovascular Health</keyword>
    <keyword>Homeless persons</keyword>
    <keyword>Delivery of Health Care, Integrated</keyword>
    <keyword>Primary care</keyword>
    <keyword>Social determinants of health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Hyperlipidemias</mesh_term>
      <mesh_term>Prediabetic State</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025721
  org study id: IRB-FY2022-373
  secondary id: P50MD017342
  nct id: NCT06025721
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This single-arm trial of the Cardiovascular Risk Reduction Among People Experiencing
        Homelessness (CV-Homes) intervention alone (n=8) will test the perception and feasibility of
        anticipated study procedures.
  This study is of a set of studies with an overall goal to develop and pilot test a
        collaborative care intervention using motivational interviewing and behavioral activation
        alongside education and psychosocial support to improve medication adherence tailored to the
        experiences of people experiencing homelessness and cardiovascular health risks (CV-H). Our
        team's central hypothesis is that medication adherence and cardiovascular self-care (and
        eventual glycemic control, cholesterol control, health care use/cost) will improve with an
        intervention tailored to the unique context of CV-H.
  
        This protocol addresses a pilot study to test patient perceptions of the feasibility and
        acceptability of study procedures and refine the CV-Homes treatment manual through test cases
        (n=8). With a hypothesis that the CV-Homes manual and study procedures will be feasible and
        acceptable to CV-H as measured by self-report and post-treatment interview.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This will be an in-person, phone, or video based behavioral intervention. It will involve a wellness coach assisting participants to set goals related to diabetes self-care and co-morbitities or social conditions that get in the way of health and wellness. There will be encouragement to work on medication adherence and to address getting healthy sleep, quitting tobacco, being more active, and eating better.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acceptability Measured by the Client Satisfaction Questionnaire
  time frame: at 16 weeks
  description: This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire, with a score range 8-32, higher score indicating greater satisfaction.
  measure: Treatment Engagement Measured by Sessions Attended
  time frame: At 16 weeks
  description: Throughout the study we will measure engagement by tracking attendance of treatment sessions.
  measure: Health-related quality of life
  time frame: Baseline to 16 weeks
  description: Health related quality of life as measured by the Euro-Qol 5D-5-L which asks 5 questions on a 5-response likert scale with 1 = no problems and 5= unable to; and one question on a scale of 1-100 with 1 being the worst health one can imagine and 100 being the best health one can imagine.
  measure: Hemoglobin A1c
  time frame: Baseline to 16 weeks
  description: Change in point-of-care hemoglobin A1c
  measure: Total cholesterol
  time frame: Baseline to 16 weeks
  description: Change in point-of-care cholesterol
  arm group label: CV-Homes Intervention
  arm group type: Experimental
  description: Behavioral treatment by a wellness coach.
  intervention type: Behavioral
  intervention name: Cardiovascular Risk Homeless Support
  description: There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve cardiovascular care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resources and care coordination. The coach will also provide brief cardiovascular health education as needed.
  arm group label: CV-Homes Intervention
  other name: CV-Homes
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Katherine D Vickery, MD
  role: Principal Investigator
  affiliation: Hennepin Healthcare Research Institute
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Hyperlipidemias
  mesh term: Prediabetic State
  sharing ipd: No