<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/NCT02243072</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DK102091-01</org_study_id>
    <secondary_id>R34DK102091</secondary_id>
    <nct_id>NCT02243072</nct_id>
  </id_info>
  <brief_title>Home-Based Interventions for Adolescents With Type 1 Diabetes</brief_title>
  <acronym>R34</acronym>
  <official_title>Translating Home-Based Interventions for Adolescents With Poorly Controlled TID</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescents with T1D and chronic poor metabolic control are at high risk for short and&#xD;
      long-term diabetes complications and are heavy users of both medical resources and health&#xD;
      care dollars. The purpose of the proposed study is to collaborate with a community agency to&#xD;
      develop and test an intervention, Fit Families, that uses the core components of a previously&#xD;
      successful home-based family treatment, but that can delivered by lower cost community health&#xD;
      workers. If successful, Fit Families could improve health outcomes in a vulnerable population&#xD;
      at high risk for diabetes complications, and could be translated to real-world treatment&#xD;
      settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a planning grant in which MST will be adapted for delivery by community&#xD;
      health workers and will be conducted in collaboration with CHASS, a community agency&#xD;
      providing health care to underserved residents of Detroit with diabetes. The new&#xD;
      intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in&#xD;
      order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect&#xD;
      sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and&#xD;
      determine potential cost savings associated with reduced hospital admissions. These steps&#xD;
      will allow for finalization of intervention content and other trial parameters in preparation&#xD;
      for a larger R18 dissemination trial.&#xD;
&#xD;
      The design for the proposed study is a randomized, controlled trial using a sample of 60&#xD;
      adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus&#xD;
      standard medical care, and the other half will be assigned to standard medical care alone.&#xD;
      Families who are randomized to FF receive intensive, home-based family therapy delivered by a&#xD;
      community health worker (CHW) for approximately six months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Control: Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Change from Baseline at 7 months, Change from Baseline at 9 months</time_frame>
    <description>retrospective measure of blood glucose control, encompasses the previous 2-3 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)</measure>
    <time_frame>Change from Baseline at 7 months, Change from Baseline at 9 months</time_frame>
    <description>The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Change from Baseline at 7 months, Change from Baseline at 9 months</time_frame>
    <description>44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads</measure>
    <time_frame>Change from Baseline at 7 months, Change from Baseline at 9 months</time_frame>
    <description>The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Fit Familes plus Standard Medical Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Medical Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fit Families plus Standard Medical Care</intervention_name>
    <description>Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months</description>
    <arm_group_label>Fit Familes plus Standard Medical Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a current hemoglobin A1c(HbA1c) of &gt;9.0%&#xD;
&#xD;
          -  an average HbA1c of &gt;9.0% during the past year&#xD;
&#xD;
          -  reside in the metro Detroit tri-county area&#xD;
&#xD;
          -  diagnosed with Type 1 diabetes for at least one year&#xD;
&#xD;
          -  aged 10-17&#xD;
&#xD;
          -  patient of Children's Hospital of Michigan Diabetes Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe mental impairment/thought disorder&#xD;
&#xD;
          -  Active suicidality&#xD;
&#xD;
          -  Active homicidality&#xD;
&#xD;
          -  Diabetes secondary to another comorbid medical condition and/or medical management&#xD;
             differing substantially from that of most children with diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah A Ellis, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Deborah Ellis, Ph.D.</investigator_full_name>
    <investigator_title>Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Insulin Dependent Diabetes Mellitus</keyword>
  <keyword>family therapy</keyword>
  <keyword>adolescents</keyword>
  <keyword>regimen adherence</keyword>
  <keyword>metabolic control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT02243072
org study id: 1R34DK102091-01
secondary id: R34DK102091
nct id: NCT02243072
lead sponsor: 
collaborator: 
has dmc: Yes
Adolescents with T1D and chronic poor metabolic control are at high risk for short and
      long-term diabetes complications and are heavy users of both medical resources and health
      care dollars. The purpose of the proposed study is to collaborate with a community agency to
      develop and test an intervention, Fit Families, that uses the core components of a previously
      successful home-based family treatment, but that can delivered by lower cost community health
      workers. If successful, Fit Families could improve health outcomes in a vulnerable population
      at high risk for diabetes complications, and could be translated to real-world treatment
      settings.
The proposed study is a planning grant in which MST will be adapted for delivery by community
      health workers and will be conducted in collaboration with CHASS, a community agency
      providing health care to underserved residents of Detroit with diabetes. The new
      intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in
      order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect
      sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and
      determine potential cost savings associated with reduced hospital admissions. These steps
      will allow for finalization of intervention content and other trial parameters in preparation
      for a larger R18 dissemination trial.

      The design for the proposed study is a randomized, controlled trial using a sample of 60
      adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus
      standard medical care, and the other half will be assigned to standard medical care alone.
      Families who are randomized to FF receive intensive, home-based family therapy delivered by a
      community health worker (CHW) for approximately six months.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Metabolic Control: Hemoglobin A1c (HbA1c)
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
description: retrospective measure of blood glucose control, encompasses the previous 2-3 months
measure: DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
description: The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
measure: Quality of life
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
description: 44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
measure: Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
description: The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
arm group label: Fit Familes plus Standard Medical Care
arm group type: Experimental
description: Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.
arm group label: Standard Medical Care
arm group type: No Intervention
description: Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.
intervention type: Behavioral
intervention name: Fit Families plus Standard Medical Care
description: Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
arm group label: Fit Familes plus Standard Medical Care
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Deborah A Ellis, Ph.D
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Deborah Ellis, Ph.D.
investigator title: Professor of Family Medicine and Public Health Sciences Wayne State University School of Medicine
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No