<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/NCT02193984</url>
  </required_header>
  <id_info>
    <org_study_id>G00007943</org_study_id>
    <nct_id>NCT02193984</nct_id>
  </id_info>
  <brief_title>Alliance to Control Diabetes</brief_title>
  <official_title>Alliance to Control Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peers for Progress</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Academy of Family Physicians</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family&#xD;
      Physicians Foundation. The study was designed to help patients better manage their diabetes,&#xD;
      and was a partnership between the Institute for Behavioral and Community Health and Clínicas&#xD;
      de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive&#xD;
      primary care services to residents throughout Imperial and Riverside Counties, California.&#xD;
      The investigators identified 336 patients with uncontrolled diabetes from three CDSDP&#xD;
      clinics. Patients were randomly assigned to intervention or control conditions. The 12-month&#xD;
      intervention consisted of individual diabetes management support delivered by a trained&#xD;
      volunteer peer supporter. The primary aim was determine if peer support can help patients&#xD;
      better manage their diabetes and improve the quality of their lives. Intervention&#xD;
      effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and&#xD;
      12 months. This study was part of the global Peers for Progress network which has been&#xD;
      testing peer support programs in 13 countries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2009</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Actual">January 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in HbA1c levels.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cholesterol.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HDL, LDL and triglycerides.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depression.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in depression of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in distress.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Changes in distress of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">336</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Peer support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer support</intervention_name>
    <arm_group_label>Peer support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 18 years old&#xD;
&#xD;
          -  Must be diagnosed with Diabetes Mellitus Type I, Diabetes Mellitus Type II or&#xD;
             Gestational Diabetes&#xD;
&#xD;
          -  Must be a resident of Imperial County&#xD;
&#xD;
          -  Must be a current patient of Clínicas de Salud del Pueblo, Inc., at one of the three&#xD;
             participating clinics&#xD;
&#xD;
          -  Must speak Spanish and/or English&#xD;
&#xD;
          -  Must plan on remaining in Imperial County for at least 12 months after enrollment into&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not be involved in any other diabetes-related study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guadalupe X Ayala, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego State University Research Foundation</name>
      <address>
        <city>Calexico</city>
        <state>California</state>
        <zip>92232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego State University Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.peersforprogress.org</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Fisher EB, Ayala GX, Ibarra L, Cherrington AL, Elder JP, Tang TS, Heisler M, Safford MM, Simmons D; Peers for Progress Investigator Group. Contributions of Peer Support to Health, Health Care, and Prevention: Papers from Peers for Progress. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S2-8. doi: 10.1370/afm.1852.</citation>
    <PMID>26304968</PMID>
  </reference>
  <reference>
    <citation>Simmons D, Bunn C, Nakwagala F, Safford MM, Ayala GX, Riddell M, Graffy J, Fisher EB. Challenges in the Ethical Review of Peer Support Interventions. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S79-86. doi: 10.1370/afm.1803.</citation>
    <PMID>26304976</PMID>
  </reference>
  <results_reference>
    <citation>Parada H Jr, Horton LA, Cherrington A, Ibarra L, Ayala GX. Correlates of medication nonadherence among Latinos with type 2 diabetes. Diabetes Educ. 2012 Jul-Aug;38(4):552-61. doi: 10.1177/0145721712445215. Epub 2012 Apr 30.</citation>
    <PMID>22546741</PMID>
  </results_reference>
  <results_reference>
    <citation>Ayala GX, Ibarra L, Cherrington AL, Parada H, Horton L, Ji M, Elder JP. Puentes hacia una mejor vida (Bridges to a Better Life): Outcome of a Diabetes Control Peer Support Intervention. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S9-17. doi: 10.1370/afm.1807.</citation>
    <PMID>26304977</PMID>
  </results_reference>
  <results_reference>
    <citation>Soto SC, Louie SY, Cherrington AL, Parada H, Horton LA, Ayala GX. An ecological perspective on diabetes self-care support, self-management behaviors, and hemoglobin A1C among Latinos. Diabetes Educ. 2015 Apr;41(2):214-23. doi: 10.1177/0145721715569078. Epub 2015 Feb 5.</citation>
    <PMID>25656696</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Guadalupe X. Ayala</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Peer support</keyword>
  <keyword>Hispanic</keyword>
  <keyword>Latino</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 6, 2017</submitted>
    <returned>July 19, 2018</returned>
  </pending_results>
  <!-- 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/NCT02193984
org study id: G00007943
nct id: NCT02193984
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family
      Physicians Foundation. The study was designed to help patients better manage their diabetes,
      and was a partnership between the Institute for Behavioral and Community Health and Clínicas
      de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive
      primary care services to residents throughout Imperial and Riverside Counties, California.
      The investigators identified 336 patients with uncontrolled diabetes from three CDSDP
      clinics. Patients were randomly assigned to intervention or control conditions. The 12-month
      intervention consisted of individual diabetes management support delivered by a trained
      volunteer peer supporter. The primary aim was determine if peer support can help patients
      better manage their diabetes and improve the quality of their lives. Intervention
      effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and
      12 months. This study was part of the global Peers for Progress network which has been
      testing peer support programs in 13 countries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in HbA1c levels.
time frame: Baseline, 6 months, 12 months
description: Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.
measure: Changes in blood pressure.
time frame: Baseline, 6 months, 12 months
description: Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.
measure: Changes in cholesterol.
time frame: Baseline, 6 months, 12 months
description: Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.
measure: Changes in HDL, LDL and triglycerides.
time frame: Baseline, 6 months, 12 months
description: Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.
measure: Changes in depression.
time frame: Baseline, 6 months, 12 months
description: Changes in depression of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).
measure: Changes in distress.
time frame: Baseline, 6 months, 12 months
description: Changes in distress of diabetes patients from baseline to 12 months as assessed by self-report via interview with a trained research assistant in the participant's language of choice (Spanish or English).
arm group label: Peer support
arm group type: Experimental
description: Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Peer support
arm group label: Peer support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guadalupe X Ayala, PhD, MPH
role: Principal Investigator
affiliation: San Diego State University
facility: 
facility: 
country: United States
url: http://www.peersforprogress.org
description: Related Info
citation: Fisher EB, Ayala GX, Ibarra L, Cherrington AL, Elder JP, Tang TS, Heisler M, Safford MM, Simmons D; Peers for Progress Investigator Group. Contributions of Peer Support to Health, Health Care, and Prevention: Papers from Peers for Progress. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S2-8. doi: 10.1370/afm.1852.
PMID: 26304968
citation: Simmons D, Bunn C, Nakwagala F, Safford MM, Ayala GX, Riddell M, Graffy J, Fisher EB. Challenges in the Ethical Review of Peer Support Interventions. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S79-86. doi: 10.1370/afm.1803.
PMID: 26304976
citation: Parada H Jr, Horton LA, Cherrington A, Ibarra L, Ayala GX. Correlates of medication nonadherence among Latinos with type 2 diabetes. Diabetes Educ. 2012 Jul-Aug;38(4):552-61. doi: 10.1177/0145721712445215. Epub 2012 Apr 30.
PMID: 22546741
citation: Ayala GX, Ibarra L, Cherrington AL, Parada H, Horton L, Ji M, Elder JP. Puentes hacia una mejor vida (Bridges to a Better Life): Outcome of a Diabetes Control Peer Support Intervention. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S9-17. doi: 10.1370/afm.1807.
PMID: 26304977
citation: Soto SC, Louie SY, Cherrington AL, Parada H, Horton LA, Ayala GX. An ecological perspective on diabetes self-care support, self-management behaviors, and hemoglobin A1C among Latinos. Diabetes Educ. 2015 Apr;41(2):214-23. doi: 10.1177/0145721715569078. Epub 2015 Feb 5.
PMID: 25656696
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Guadalupe X. Ayala
investigator title: Professor
mesh term: Diabetes Mellitus
submitted: October 6, 2017
returned: July 19, 2018