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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Peer support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Alliance to Control Diabetes
Study Start Date : February 2009
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : September 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Peer support
Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.
 Behavioral: Peer support
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193984


Locations
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United States, California
San Diego State University Research Foundation
Calexico, California, United States, 92232
San Diego State University Research Foundation
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
Peers for Progress
American Academy of Family Physicians
Investigators
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Principal Investigator: Guadalupe X Ayala, PhD, MPH San Diego State University
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Guadalupe X. Ayala, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT02193984    
Other Study ID Numbers: G00007943
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Keywords provided by Guadalupe X. Ayala, San Diego State University:
Diabetes
Peer support
Hispanic
Latino
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases