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/NCT06031428</url>
    </required_header>
    <id_info>
      <org_study_id>PRO00044942</org_study_id>
      <nct_id>NCT06031428</nct_id>
    </id_info>
    <brief_title>MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration</brief_title>
    <acronym>MANAGe-DM</acronym>
    <official_title>MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical College of Wisconsin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical College of Wisconsin</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>
        The study is a randomized control trial involving 100 participants (Black men with poorly&#xD;
        controlled diabetes within 1 year of release from incarceration) to examine the effect of a&#xD;
        tailored nurse case manager on glycemic control and other clinical outcomes, self-care&#xD;
        behaviors, and quality of life at 6 months post-randomization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a randomized control trial involving 100 participants (Black men within 1 year&#xD;
        of release from incarceration) to examine the effect of a tailored nurse case manager on&#xD;
        glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6&#xD;
        months post-randomization. Participants assigned to MANAGe-DM will receive the standard&#xD;
        diabetes education mailing in addition to a novel nurse case management intervention. Nurse&#xD;
        case managers are trained RNs who support patients with T2DM by coordinating services,&#xD;
        supporting self-care and implementing disease management strategies (Welch 2010). MANAGe-DM&#xD;
        will include NCM services tailored to the health needs of Black men with recent release from&#xD;
        incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and&#xD;
        skills training; 2) healthcare navigation and 3) basic needs navigation. The NCM will serve&#xD;
        as an adjunct to the participant's primary care provider; they will not be embedded within a&#xD;
        clinic but instead interact with the participant over the phone after study recruitment from&#xD;
        a community setting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 28, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2026</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hemoglobin A1C</measure>
      <time_frame>6 months post-randomization</time_frame>
      <description>Venous draw will be use to obtain HbA1C</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>6 months post-randomization</time_frame>
      <description>Blood pressure readings (both systolic and diastolic) will be obtained using automated BP monitors programmed to take 3 readings at 2 minute intervals and give average of the 3 readings</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (Short Form Health Survey, SF-12)</measure>
      <time_frame>6 months post-randomization</time_frame>
      <description>The Short Form Health Survey (SF-12) version 1, developed by Ware et al. in 1996 is a valid and reliable instrument that will be used to measure quality of life. Scores will be reported in physical health related (PCS) and mental health related (MCS). Scores range from 0 to 100 with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MANAGe-DM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. . Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MANAGe-DM - novel nurse case management</intervention_name>
      <description>Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.</description>
      <arm_group_label>MANAGe-DM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Monthly Educational Mailing</intervention_name>
      <description>All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education. Topics covered will include diabetes basics, monitoring and medications, healthy eating and exercise, overview of common comorbidities, basics of foot care, and strategies for overcoming common pitfalls.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥18 years&#xD;
  &#xD;
            -  identify as Black or African American&#xD;
  &#xD;
            -  identify as male&#xD;
  &#xD;
            -  released from the state or federal prison system or county jail in prior 12 months&#xD;
  &#xD;
            -  clinical diagnosis of type 2 diabetes with HbA1c ≥8% at the screening visit&#xD;
  &#xD;
            -  able to communicate in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  mental confusion on screening interview suggesting significant dementia&#xD;
  &#xD;
            -  current participation in other diabetes clinical trials&#xD;
  &#xD;
            -  active psychosis or acute mental disorder&#xD;
  &#xD;
            -  life expectancy &lt;12 months&#xD;
  &#xD;
            -  awaiting arraignment, trial, sentencing in the criminal legal system&#xD;
  &#xD;
            -  on active surveillance by the criminal legal system, meaning on house arrest or&#xD;
               subject to electronic monitoring&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Eligibility is based on self-representation of gender identity</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laura Hawks, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical College of Wisconsin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura Hawks, MD</last_name>
      <phone>414-955-8020</phone>
      <email>lhawks@mcw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Center for Advancing Population Science, Medical College of Wisconsin</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laura Hawks, MD</last_name>
        <phone>414-955-8020</phone>
        <email>lhawks@mcw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
      <investigator_full_name>Laura Hawks</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</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/NCT06031428
  org study id: PRO00044942
  nct id: NCT06031428
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is a randomized control trial involving 100 participants (Black men with poorly
        controlled diabetes within 1 year of release from incarceration) to examine the effect of a
        tailored nurse case manager on glycemic control and other clinical outcomes, self-care
        behaviors, and quality of life at 6 months post-randomization.
  The study is a randomized control trial involving 100 participants (Black men within 1 year
        of release from incarceration) to examine the effect of a tailored nurse case manager on
        glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6
        months post-randomization. Participants assigned to MANAGe-DM will receive the standard
        diabetes education mailing in addition to a novel nurse case management intervention. Nurse
        case managers are trained RNs who support patients with T2DM by coordinating services,
        supporting self-care and implementing disease management strategies (Welch 2010). MANAGe-DM
        will include NCM services tailored to the health needs of Black men with recent release from
        incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and
        skills training; 2) healthcare navigation and 3) basic needs navigation. The NCM will serve
        as an adjunct to the participant's primary care provider; they will not be embedded within a
        clinic but instead interact with the participant over the phone after study recruitment from
        a community setting.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Hemoglobin A1C
  time frame: 6 months post-randomization
  description: Venous draw will be use to obtain HbA1C
  measure: Blood Pressure
  time frame: 6 months post-randomization
  description: Blood pressure readings (both systolic and diastolic) will be obtained using automated BP monitors programmed to take 3 readings at 2 minute intervals and give average of the 3 readings
  measure: Quality of Life (Short Form Health Survey, SF-12)
  time frame: 6 months post-randomization
  description: The Short Form Health Survey (SF-12) version 1, developed by Ware et al. in 1996 is a valid and reliable instrument that will be used to measure quality of life. Scores will be reported in physical health related (PCS) and mental health related (MCS). Scores range from 0 to 100 with higher scores indicating better quality of life.
  arm group label: Control
  arm group type: Active Comparator
  description: All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education.
  arm group label: MANAGe-DM
  arm group type: Experimental
  description: Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. . Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.
  intervention type: Behavioral
  intervention name: MANAGe-DM - novel nurse case management
  description: Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.
  arm group label: MANAGe-DM
  intervention type: Behavioral
  intervention name: Monthly Educational Mailing
  description: All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education. Topics covered will include diabetes basics, monitoring and medications, healthy eating and exercise, overview of common comorbidities, basics of foot care, and strategies for overcoming common pitfalls.
  arm group label: Control
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Eligibility is based on self-representation of gender identity
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laura Hawks, MD
  role: Principal Investigator
  affiliation: Medical College of Wisconsin
  last name: Laura Hawks, MD
  phone: 414-955-8020
  email: lhawks@mcw.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical College of Wisconsin
  investigator full name: Laura Hawks
  investigator title: Assistant Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No