<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/NCT03006666</url>
  </required_header>
  <id_info>
    <org_study_id>16-00690</org_study_id>
    <nct_id>NCT03006666</nct_id>
  </id_info>
  <brief_title>Integrating Community Health Workers to Improve Diabetes Prevention</brief_title>
  <official_title>Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      Cluster randomized trial to test the impact of peer health coaches on prediabetic patients.&#xD;
      This study will test a scalable model of peer health coaching to address the millions of&#xD;
      patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to&#xD;
      promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This population based trial aims to understand the impact of peer health interventions on&#xD;
      panels of patients in a real clinic environment&#xD;
&#xD;
      Investigators will conduct a cluster-randomized trial to test the impact of peer health&#xD;
      coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams&#xD;
      to:&#xD;
&#xD;
        1. Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;&#xD;
&#xD;
        2. Promote weight loss among pre-diabetic patients;&#xD;
&#xD;
        3. Increase patient activation levels, a measureable construct of engagement, efficacy,&#xD;
           skills, and confidence in managing one's health, among pre-DM patients, resulting in:&#xD;
&#xD;
             1. Improved secondary clinical outcomes: better glycemic and blood pressure control,&#xD;
                and lower Framingham risk scores;&#xD;
&#xD;
             2. Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy&#xD;
                Lifestyles, etc);&#xD;
&#xD;
             3. Improved health behaviors (e.g. making dietary and exercise changes); and&#xD;
&#xD;
        4. Develop, implement and assess strategies to recruit, train, and integrate peer CHW&#xD;
           health coaches within the PCMH model.&#xD;
&#xD;
      This study will test a scalable model of peer health coaching to address the millions of&#xD;
      patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to&#xD;
      promote prevention of DM in PCMH practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rates of type 2 DM</measure>
    <time_frame>36 Months</time_frame>
    <description>Cumulative DM incidence rates and time to DM incidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight loss and obesity rates</measure>
    <time_frame>36 Months</time_frame>
    <description>Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Activation Measure (PAM) scores</measure>
    <time_frame>36 Months</time_frame>
    <description>The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">773</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Control Group (Data Only)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The teams randomly allocated to the Control Group will not have access to CHWs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group: (CHW Health Coaching Integrated into Team)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHW Training</intervention_name>
    <description>CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.&#xD;
In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .&#xD;
The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with &quot;mock&quot; participants (consisting of research staff and advisory board members).&#xD;
Individuals who do not pass will receive intensive remediation and be required to repeat the examination.&#xD;
Community Health Worker Coaching Intervention.</description>
    <arm_group_label>Intervention Group: (CHW Health Coaching Integrated into Team)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Data Only</intervention_name>
    <description>The teams randomly allocated will not have access to Community Health Workers.</description>
    <arm_group_label>Control Group (Data Only)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years&#xD;
             prior to the start date of Phase 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2&#xD;
             years prior to Phase 2&#xD;
&#xD;
          -  Treatment with DM medication other than metformin (e.g. insulin or oral agents)&#xD;
&#xD;
          -  age greater than 75 years&#xD;
&#xD;
          -  exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW&#xD;
             outreach.&#xD;
&#xD;
          -  Does not speak English or Spanish (necessary to communicate with community health&#xD;
             worker)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03006666/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03006666
org study id: 16-00690
nct id: NCT03006666
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients.
      This study will test a scalable model of peer health coaching to address the millions of
      patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to
      promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.
This population based trial aims to understand the impact of peer health interventions on
      panels of patients in a real clinic environment

      Investigators will conduct a cluster-randomized trial to test the impact of peer health
      coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams
      to:

        1. Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;

        2. Promote weight loss among pre-diabetic patients;

        3. Increase patient activation levels, a measureable construct of engagement, efficacy,
           skills, and confidence in managing one's health, among pre-DM patients, resulting in:

             1. Improved secondary clinical outcomes: better glycemic and blood pressure control,
                and lower Framingham risk scores;

             2. Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy
                Lifestyles, etc);

             3. Improved health behaviors (e.g. making dietary and exercise changes); and

        4. Develop, implement and assess strategies to recruit, train, and integrate peer CHW
           health coaches within the PCMH model.

      This study will test a scalable model of peer health coaching to address the millions of
      patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to
      promote prevention of DM in PCMH practice.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence rates of type 2 DM
time frame: 36 Months
description: Cumulative DM incidence rates and time to DM incidence
measure: Weight loss and obesity rates
time frame: 36 Months
description: Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.
measure: Patient Activation Measure (PAM) scores
time frame: 36 Months
description: The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.
arm group label: Control Group (Data Only)
arm group type: Active Comparator
description: The teams randomly allocated to the Control Group will not have access to CHWs.
arm group label: Intervention Group: (CHW Health Coaching Integrated into Team)
arm group type: Experimental
description: Teams randomly allocated to the Intervention Group will also receive regular panel data on their pre-DM patients and will have a CHW join the team, attend team meetings, and provide an outreach intervention to all prediabetic patients in the panel, as described below. CHWs and the researchers will provide regular updates to the team on these activities.
intervention type: Behavioral
intervention name: CHW Training
description: CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.
In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .
The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with "mock" participants (consisting of research staff and advisory board members).
Individuals who do not pass will receive intensive remediation and be required to repeat the examination.
Community Health Worker Coaching Intervention.
arm group label: Intervention Group: (CHW Health Coaching Integrated into Team)
intervention type: Behavioral
intervention name: Data Only
description: The teams randomly allocated will not have access to Community Health Workers.
arm group label: Control Group (Data Only)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark Schwartz, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
provided document: 