Alliance to Control Diabetes

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Peer support

• Registration Number: NCT02193984
• Lead Sponsor: San Diego State University

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 available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-01
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer support	Peer support	Study participants are assigned a volunteer peer supporter who has been trained to offer support on diabetes management.

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c levels.	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

Name	Time	Method
Changes in blood pressure.	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.	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.	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.	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.	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).

Trial Locations

Locations (1)

San Diego State University Research Foundation; 🇺🇸 San Diego, California, United States