Alliance to Control Diabetes

• ClinicalTrials.gov Identifier: NCT02193984
• Recruitment Status: Unknown
• First Posted: July 18, 2014
• Last Update Posted: January 13, 2017
• Sponsor: San Diego State University
• 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: July 16, 2014
• First Posted Date: July 18, 2014
• Last Update Posted Date: January 13, 2017
• Study Start Date: February 2009
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alliance to Control Diabetes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Diabetes Mellitus
• Intervention: Behavioral: Peer support

Study Arms

• 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 *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 17, 2014): 336
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 2017
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02193984
• Other Study ID Numbers: G00007943
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Guadalupe X. Ayala, San Diego State University
• Study Sponsor: San Diego State University

Collaborators

• Peers for Progress
• American Academy of Family Physicians

Investigators

• Principal Investigator: Guadalupe X Ayala, PhD, MPH; San Diego State University

• PRS Account: San Diego State University
• Verification Date: January 2017