Alliance to Control Diabetes
January 12, 2017 updated by: Guadalupe X. Ayala, San Diego State University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
336
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Calexico, California, United States, 92232
- San Diego State University Research Foundation
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San Diego, California, United States, 92123
- San Diego State University Research Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
No intervention
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Experimental: Peer support
Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in HbA1c levels.
Time Frame: Baseline, 6 months, 12 months
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Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.
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Baseline, 6 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in blood pressure.
Time Frame: Baseline, 6 months, 12 months
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Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.
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Baseline, 6 months, 12 months
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Changes in cholesterol.
Time Frame: Baseline, 6 months, 12 months
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Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.
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Baseline, 6 months, 12 months
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Changes in HDL, LDL and triglycerides.
Time Frame: Baseline, 6 months, 12 months
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Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.
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Baseline, 6 months, 12 months
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Changes in depression.
Time Frame: Baseline, 6 months, 12 months
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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).
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Baseline, 6 months, 12 months
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Changes in distress.
Time Frame: Baseline, 6 months, 12 months
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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).
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Baseline, 6 months, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guadalupe X Ayala, PhD, MPH, San Diego State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
July 16, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G00007943
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