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Alliance to Control Diabetes

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ClinicalTrials.gov Identifier: NCT02193984
Recruitment Status : Unknown
Verified January 2017 by Guadalupe X. Ayala, San Diego State University.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2014
Last Update Posted : January 13, 2017
Sponsor:
Collaborators:
Peers for Progress
American Academy of Family Physicians
Information provided by (Responsible Party):
Guadalupe X. Ayala, San Diego State University

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 18, 2014
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE February 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
Changes in HbA1c levels. [ Time Frame: Baseline, 6 months, 12 months ]
Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
  • Changes in blood pressure. [ Time Frame: Baseline, 6 months, 12 months ]
    Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.
  • Changes in cholesterol. [ Time Frame: Baseline, 6 months, 12 months ]
    Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.
  • Changes in HDL, LDL and triglycerides. [ Time Frame: Baseline, 6 months, 12 months ]
    Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.
  • Changes in depression. [ Time Frame: Baseline, 6 months, 12 months ]
    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).
  • Changes in distress. [ Time Frame: Baseline, 6 months, 12 months ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alliance to Control Diabetes
Official Title  ICMJE Alliance to Control Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Behavioral: Peer support
Study Arms  ICMJE
  • Experimental: Peer support
    Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.
    Intervention: Behavioral: Peer support
  • No Intervention: Control
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 17, 2014)
336
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be at least 18 years old
  • Must be diagnosed with Diabetes Mellitus Type I, Diabetes Mellitus Type II or Gestational Diabetes
  • Must be a resident of Imperial County
  • Must be a current patient of Clínicas de Salud del Pueblo, Inc., at one of the three participating clinics
  • Must speak Spanish and/or English
  • Must plan on remaining in Imperial County for at least 12 months after enrollment into the study

Exclusion Criteria:

  • Must not be involved in any other diabetes-related study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02193984
Other Study ID Numbers  ICMJE G00007943
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guadalupe X. Ayala, San Diego State University
Study Sponsor  ICMJE San Diego State University
Collaborators  ICMJE
  • Peers for Progress
  • American Academy of Family Physicians
Investigators  ICMJE
Principal Investigator: Guadalupe X Ayala, PhD, MPH San Diego State University
PRS Account San Diego State University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP