<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/NCT04402125</url>
  </required_header>
  <id_info>
    <org_study_id>R01NR018023</org_study_id>
    <secondary_id>R01NR018023</secondary_id>
    <nct_id>NCT04402125</nct_id>
  </id_info>
  <brief_title>Reducing Stroke Risk in African-American Men</brief_title>
  <acronym>TEAM2</acronym>
  <official_title>Reducing Stroke Risk in African-American Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Case Western Reserve 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>
      The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of&#xD;
      TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African&#xD;
      American men who have experienced a stroke or TIA within the past 5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of&#xD;
      TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African&#xD;
      American men who have experienced a stroke or TIA within the past 5 years. TEAM features a&#xD;
      nurse-led, person-centered, holistic intervention that takes advantage of existing strengths&#xD;
      in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model&#xD;
      behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his&#xD;
      own stroke risk and a care partner. A care partner is someone who is the family member,&#xD;
      friend or other individual of someone who has had a stroke or TIA. A care partner can be&#xD;
      associated with a PE but they do not have to be. PEs and care partners will be matched&#xD;
      depending on schedules and availability and may not always be members of the same household.&#xD;
      The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA.&#xD;
      Patients are also encouraged to include a family, friend, or other individual important his&#xD;
      stroke recovery in the TEAM programming. The intervention is a practical approach suitable&#xD;
      for implementation in specialty, primary care or community settings, and has the potential to&#xD;
      reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</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>80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TEAM vs WL change in systolic BP</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in systolic BP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in diastolic BP</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in diastolic BP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in cholesterol</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in HDL</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in HDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in LDL</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in LDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in triglycerides</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in BMI</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TEAM vs WL change in HbA1c</measure>
    <time_frame>Baseline to 6-month follow up</time_frame>
    <description>TEAM vs WL change in HbA1c</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Stroke</condition>
  <condition>Transient Ischemic Attack</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants randomized to waitlist for 6 months, then offered the intervention for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TargEted MAnageMent Intervention (TEAM)</intervention_name>
    <description>TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows:&#xD;
A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning.&#xD;
Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED.&#xD;
Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Waitlist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for RCT participant:&#xD;
&#xD;
          1. Age range 18 to 90&#xD;
&#xD;
          2. Self-identified African American male&#xD;
&#xD;
          3. Have had a stroke or TIA in the past 5 years based on date of hospital discharge from&#xD;
             an acute stroke program or Emergency Room/physician visit for TIA&#xD;
&#xD;
          4. Barthel Index (BI) score of &gt;60&#xD;
&#xD;
          5. Able to participate in group sessions&#xD;
&#xD;
        Inclusion Criteria for Care Partner&#xD;
&#xD;
          1. Age range from 18 to 90&#xD;
&#xD;
          2. Able to participate in group sessions&#xD;
&#xD;
        Inclusion criteria for peer educator:&#xD;
&#xD;
          1. Age range: from 18 to 90&#xD;
&#xD;
          2. Self-identified African American male&#xD;
&#xD;
          3. Have had a stroke or TIA&#xD;
&#xD;
          4. Able to participate in group sessions&#xD;
&#xD;
        Inclusion Criteria for Peer Educator Care Partner&#xD;
&#xD;
          1. Age range: from 18 to 90&#xD;
&#xD;
          2. Able to participate in group sessions&#xD;
&#xD;
          3. Is either a family member, friend or other individual who is important in an enrolled&#xD;
             peer educator's stroke recovery OR the family member, friend or other individual of&#xD;
             someone who has had a stroke or TIA and is/was important in their stroke recovery&#xD;
&#xD;
        Exclusion Criteria for RCT participant&#xD;
&#xD;
          1. Individuals who are unable or unwilling to provide written informed consent&#xD;
&#xD;
          2. Individuals who have had stroke due to sickle-cell disease&#xD;
&#xD;
        Exclusion Criteria for Care Partner participant 1. Individuals who are unable or unwilling&#xD;
        to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria for Peer Educator&#xD;
&#xD;
          1. Individuals who are unable or unwilling to provide written informed consent&#xD;
&#xD;
          2. Individuals who have had stroke due to sickle-cell disease&#xD;
&#xD;
        Exclusion Criteria for Peer Educator's Care Partner&#xD;
&#xD;
        1. Individuals who are unable or unwilling to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha Sajatovic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Manager</last_name>
    <phone>888-819-0004</phone>
    <email>carla.conroy@uhhospitals.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>888-819-0004</phone>
    </contact>
    <investigator>
      <last_name>Martha Sajatovic, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Martha Sajatovic, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Attack, Transient</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/NCT04402125
org study id: R01NR018023
secondary id: R01NR018023
nct id: NCT04402125
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of
      TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African
      American men who have experienced a stroke or TIA within the past 5 years.
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of
      TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African
      American men who have experienced a stroke or TIA within the past 5 years. TEAM features a
      nurse-led, person-centered, holistic intervention that takes advantage of existing strengths
      in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model
      behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his
      own stroke risk and a care partner. A care partner is someone who is the family member,
      friend or other individual of someone who has had a stroke or TIA. A care partner can be
      associated with a PE but they do not have to be. PEs and care partners will be matched
      depending on schedules and availability and may not always be members of the same household.
      The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA.
      Patients are also encouraged to include a family, friend, or other individual important his
      stroke recovery in the TEAM programming. The intervention is a practical approach suitable
      for implementation in specialty, primary care or community settings, and has the potential to
      reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
primary purpose: Treatment
masking: None (Open Label)
measure: TEAM vs WL change in systolic BP
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in systolic BP
measure: TEAM vs WL change in diastolic BP
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in diastolic BP
measure: TEAM vs WL change in cholesterol
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in cholesterol
measure: TEAM vs WL change in HDL
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in HDL
measure: TEAM vs WL change in LDL
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in LDL
measure: TEAM vs WL change in triglycerides
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in triglycerides
measure: TEAM vs WL change in BMI
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in BMI
measure: TEAM vs WL change in HbA1c
time frame: Baseline to 6-month follow up
description: TEAM vs WL change in HbA1c
arm group label: Intervention
arm group type: Experimental
description: Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up
arm group label: Waitlist
arm group type: Other
description: Participants randomized to waitlist for 6 months, then offered the intervention for 6 months
intervention type: Behavioral
intervention name: TargEted MAnageMent Intervention (TEAM)
description: TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows:
A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning.
Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED.
Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers.
arm group label: Intervention
arm group label: Waitlist
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Martha Sajatovic, MD
role: Principal Investigator
affiliation: Case Western Reserve University
last name: Research Manager
phone: 888-819-0004
email: carla.conroy@uhhospitals.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Martha Sajatovic, MD
investigator title: Professor
mesh term: Stroke
mesh term: Ischemic Attack, Transient