Clinical trial NCT02193984: Alliance to Control Diabetes
Official title: Alliance to Control Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Peer support
Hispanic
Latino
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Peers for Progress
name: American Academy of Family Physicians
First posted: 2014-07-18
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Changes in HbA1c levels.
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Changes in blood pressure.
timeFrame: Baseline, 6 months, 12 months
measure: Changes in cholesterol.
timeFrame: Baseline, 6 months, 12 months
measure: Changes in HDL, LDL and triglycerides.
timeFrame: Baseline, 6 months, 12 months
measure: Changes in depression.
timeFrame: Baseline, 6 months, 12 months
measure: Changes in distress.
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Calexico
country: United States
facility: San Diego State University Research Foundation
state: California
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
affiliation: San Diego State University
name: Guadalupe X Ayala, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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(Suppl 1):S2-8. doi: 10.1370/afm.1852.
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(Suppl 1):S79-86. doi: 10.1370/afm.1803.
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.
citation: 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.
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. Epub 2015 Feb 5.