<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/NCT02994095</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00073693</org_study_id>
    <nct_id>NCT02994095</nct_id>
  </id_info>
  <brief_title>A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program</brief_title>
  <official_title>A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program Using Motivational Interviewing-based Approaches in a Public Primary Care Center in São Paulo, Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a pilot study to assess the feasibility and acceptability of training Community&#xD;
      Health Agents in Motivational Interviewing in real-life primary care centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and&#xD;
      middle-income countries such as Brazil. Scalable primary care-based interventions are needed&#xD;
      to improve self-management and clinical outcomes of adults with diabetes. This pilot study&#xD;
      examines the feasibility, acceptability, and outcomes of training community health agents&#xD;
      (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled&#xD;
      diabetes in a primary care center in São Paulo, Brazil.&#xD;
&#xD;
      Nineteen salaried CHAs participated in 32 hours of training in MI and behavioral action&#xD;
      planning. With support from booster training sessions, they used these skills in their&#xD;
      regular monthly home visits over a 6 month period with 57 diabetes patients with baseline&#xD;
      HbA1cs &gt; 7.0%. The primary outcome was patients' reports of the quality of diabetes care as&#xD;
      measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC)&#xD;
      scale. Secondary outcomes included changes in patients' reported diabetes self-management&#xD;
      behaviors and in A1c, blood pressure, cholesterol and triglycerides. CHAs' fidelity to and&#xD;
      experiences with the intervention were also assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PACIC score</measure>
    <time_frame>Six months</time_frame>
    <description>Quality of Diabetes Care Received</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Single intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trained CHAs in Motivational Interviewing in pilot study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pilot Study</intervention_name>
    <description>Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes</description>
    <arm_group_label>Single intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with T2 diabetes who received care at the primary care center&#xD;
&#xD;
          -  A1c&gt;7.0% in prior six months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 75&#xD;
&#xD;
          -  being pregnant&#xD;
&#xD;
          -  having terminal health condition or other conditions that would impede participation&#xD;
             such as dementia and mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Heisler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Mary Ellen Michele Heisler</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>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data set available on request.</ipd_description>
  </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/NCT02994095
org study id: HUM00073693
nct id: NCT02994095
lead sponsor: 
has dmc: No
This was a pilot study to assess the feasibility and acceptability of training Community
      Health Agents in Motivational Interviewing in real-life primary care centers.
Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and
      middle-income countries such as Brazil. Scalable primary care-based interventions are needed
      to improve self-management and clinical outcomes of adults with diabetes. This pilot study
      examines the feasibility, acceptability, and outcomes of training community health agents
      (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled
      diabetes in a primary care center in São Paulo, Brazil.

      Nineteen salaried CHAs participated in 32 hours of training in MI and behavioral action
      planning. With support from booster training sessions, they used these skills in their
      regular monthly home visits over a 6 month period with 57 diabetes patients with baseline
      HbA1cs > 7.0%. The primary outcome was patients' reports of the quality of diabetes care as
      measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC)
      scale. Secondary outcomes included changes in patients' reported diabetes self-management
      behaviors and in A1c, blood pressure, cholesterol and triglycerides. CHAs' fidelity to and
      experiences with the intervention were also assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: PACIC score
time frame: Six months
description: Quality of Diabetes Care Received
arm group label: Single intervention arm
arm group type: Experimental
description: Trained CHAs in Motivational Interviewing in pilot study
intervention type: Behavioral
intervention name: Pilot Study
description: Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes
arm group label: Single intervention arm
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michele Heisler, MD
role: Principal Investigator
affiliation: University of Michigan
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Mary Ellen Michele Heisler
investigator title: Professor
mesh term: Diabetes Mellitus
sharing ipd: Yes
ipd description: De-identified data set available on request.