<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/NCT02234973</url>
  </required_header>
  <id_info>
    <org_study_id>0000031372</org_study_id>
    <nct_id>NCT02234973</nct_id>
  </id_info>
  <brief_title>Transformation of Indigenous Primary Healthcare Delivery</brief_title>
  <acronym>FORGE AHEAD</acronym>
  <official_title>Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Nation Community Partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Nations and Inuit Health Branch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assembly of First Nations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Stroke Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto Health Economics and Technology Assessment Collaborative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tri-Ethnic Research Center Colorado State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hindsight Healthcare Strategies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <brief_summary>
    <textblock>
      Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health&#xD;
      outcomes compared to the general population because of a wide array of factors: social&#xD;
      determinants of health, lifestyle, genetic susceptibility, and historic-political and&#xD;
      psycho-social factors. Barriers to care that are unique to First Nations communities&#xD;
      exacerbate the problem with fragmented healthcare, poor chronic disease management,&#xD;
      healthcare staff turnover, and limited, or non-existent, surveillance.&#xD;
&#xD;
      Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research&#xD;
      program aims to develop and evaluate community-driven, culturally relevant, primary&#xD;
      healthcare models that enhance chronic disease prevention and management in First Nations&#xD;
      communities in Canada. Participants will consist of Indigenous community and clinic team&#xD;
      members that will take part in multiple interrelated projects including community profiling,&#xD;
      readiness consultations, diabetes registry and surveillance, and quality improvement&#xD;
      workshops and action periods.&#xD;
&#xD;
      Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical&#xD;
      process and outcomes measures, 2) details about community-driven innovations, and 3)&#xD;
      knowledge about the experience and cost of attempting to improve primary delivery in&#xD;
      individual Indigenous communities.&#xD;
&#xD;
      Intervention/Instrument: Survey, literature review, 15 month intervention (readiness&#xD;
      consultations, implementation and maintenance of a registry and surveillance system,&#xD;
      community and clinic focused quality improvement workshops), interviews.&#xD;
&#xD;
      Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);&#xD;
      Secondary-clinical process and outcome measures, change in stage of readiness, description of&#xD;
      participation and innovation facilitators and barriers.&#xD;
&#xD;
      Policy Implications: The outcomes of this research program have the potential to&#xD;
      significantly affect future policy decisions pertaining to chronic disease care in First&#xD;
      Nations communities. Policy recommendations will be made to help support Indigenous&#xD;
      communities in adopting successful innovations to help address issues related to diabetes and&#xD;
      other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the&#xD;
      subsequent policy decisions may enhance chronic disease prevention and management for&#xD;
      Indigenous peoples across the country.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)</measure>
    <time_frame>repeated measures: baseline (12 months prior to the start of the program)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)</measure>
    <time_frame>repeated measures: 6 month after program start date</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)</measure>
    <time_frame>repeated measures: 12 month after program start date</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)</measure>
    <time_frame>repeated measure: 18 months after program start</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)</measure>
    <time_frame>repeated measure: 24 months after program start</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>11 First Nations Community and Clinical Teams</arm_group_label>
    <description>11 Community &amp; Clinical Teams in each First Nation community participated in the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality Improvement</intervention_name>
    <description>Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.</description>
    <arm_group_label>11 First Nations Community and Clinical Teams</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Indigenous community and clinic team members&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Community members&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  on-reserve residents of participating Indigenous community partners&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years of age&#xD;
&#xD;
          -  off-reserve residents of participating or non-participating Indigenous community&#xD;
             partners&#xD;
&#xD;
        Clinic team members&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Health centers of participating Indigenous community partners&#xD;
&#xD;
          -  Current type 2 diabetes mellitus registry and surveillance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health centers of non-participating Indigenous community partners&#xD;
&#xD;
          -  No registry or surveillance system&#xD;
&#xD;
        Diabetes Registry&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life&#xD;
             expectancy &lt;6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stewart B Harris, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Studies in Family Medicine, Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G2M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.uwo.ca/diabetesalliance/indigenous/forge_ahead/index.html?fbclid=IwAR0I2pLaNnglhcgRb_bWQwkMCIfY-SOLcgX_sDgoz2ydrnVnYdjDRUfLqZk</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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, Type 2</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/NCT02234973
org study id: 0000031372
nct id: NCT02234973
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health
      outcomes compared to the general population because of a wide array of factors: social
      determinants of health, lifestyle, genetic susceptibility, and historic-political and
      psycho-social factors. Barriers to care that are unique to First Nations communities
      exacerbate the problem with fragmented healthcare, poor chronic disease management,
      healthcare staff turnover, and limited, or non-existent, surveillance.

      Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research
      program aims to develop and evaluate community-driven, culturally relevant, primary
      healthcare models that enhance chronic disease prevention and management in First Nations
      communities in Canada. Participants will consist of Indigenous community and clinic team
      members that will take part in multiple interrelated projects including community profiling,
      readiness consultations, diabetes registry and surveillance, and quality improvement
      workshops and action periods.

      Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical
      process and outcomes measures, 2) details about community-driven innovations, and 3)
      knowledge about the experience and cost of attempting to improve primary delivery in
      individual Indigenous communities.

      Intervention/Instrument: Survey, literature review, 15 month intervention (readiness
      consultations, implementation and maintenance of a registry and surveillance system,
      community and clinic focused quality improvement workshops), interviews.

      Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline);
      Secondary-clinical process and outcome measures, change in stage of readiness, description of
      participation and innovation facilitators and barriers.

      Policy Implications: The outcomes of this research program have the potential to
      significantly affect future policy decisions pertaining to chronic disease care in First
      Nations communities. Policy recommendations will be made to help support Indigenous
      communities in adopting successful innovations to help address issues related to diabetes and
      other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the
      subsequent policy decisions may enhance chronic disease prevention and management for
      Indigenous peoples across the country.
observational model: Case-Only
time perspective: Prospective
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
time frame: repeated measures: baseline (12 months prior to the start of the program)
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
time frame: repeated measures: 6 month after program start date
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
time frame: repeated measures: 12 month after program start date
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
time frame: repeated measure: 18 months after program start
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
time frame: repeated measure: 24 months after program start
arm group label: 11 First Nations Community and Clinical Teams
description: 11 Community & Clinical Teams in each First Nation community participated in the intervention.
intervention type: Behavioral
intervention name: Quality Improvement
description: Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.
arm group label: 11 First Nations Community and Clinical Teams
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stewart B Harris, MD, MPH
role: Principal Investigator
affiliation: Western University
facility: 
country: Canada
url: https://www.uwo.ca/diabetesalliance/indigenous/forge_ahead/index.html?fbclid=IwAR0I2pLaNnglhcgRb_bWQwkMCIfY-SOLcgX_sDgoz2ydrnVnYdjDRUfLqZk
description: Related Info
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2