Alliance to Control Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Alliance to Control Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02193984
• Other study ID #: G00007943
• Status: Active, not recruiting
• Phase: N/A
• First received: July 16, 2014
• Last updated: January 12, 2017
• Start date: February 2009
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: September 2017
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Peer support

Locations

Country	Name	City	State
United States	San Diego State University Research Foundation	Calexico	California
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
San Diego State University	American Academy of Family Physicians, Peers for Progress

Country where clinical trial is conducted

United States, 

References & Publications (5)

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:S9-17. doi: 10.1370/afm.1807. — View 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:S2-8. doi: 10.1370/afm.1852. — View 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. — View 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:S79-86. doi: 10.1370/afm.1803. — View 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c levels.	Changes in HbA1c levels of diabetes patients from baseline to 12 months as assessed by medical chart review of blood draw results.	Baseline, 6 months, 12 months
Secondary	Changes in blood pressure.	Changes in blood pressure of diabetes patients from baseline to 12 months as assessed by medical chart review.	Baseline, 6 months, 12 months
Secondary	Changes in cholesterol.	Changes in cholesterol of diabetes patients from baseline to 12 months as assessed by medical chart review.	Baseline, 6 months, 12 months
Secondary	Changes in HDL, LDL and triglycerides.	Changes in HDL, LDL and triglycerides of diabetes patients from baseline to 12 months as assessed by medical chart review.	Baseline, 6 months, 12 months
Secondary	Changes in depression.	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).	Baseline, 6 months, 12 months
Secondary	Changes in distress.	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).	Baseline, 6 months, 12 months

External Links

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