NCT02193984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

July 16, 2014

Last Update Submit

January 12, 2017

Conditions

Keywords

DiabetesPeer supportHispanicLatino

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes in blood pressure.

    Baseline, 6 months, 12 months

  • Changes in cholesterol.

    Baseline, 6 months, 12 months

  • Changes in HDL, LDL and triglycerides.

    Baseline, 6 months, 12 months

  • Changes in depression.

    Baseline, 6 months, 12 months

  • Changes in distress.

    Baseline, 6 months, 12 months

Study Arms (2)

Peer support

EXPERIMENTAL

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

Behavioral: Peer support

Control

NO INTERVENTION

No intervention

Interventions

Peer supportBEHAVIORAL
Peer support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Must not be involved in any other diabetes-related study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego State University Research Foundation

Calexico, California, 92232, United States

Location

San Diego State University Research Foundation

San Diego, California, 92123, United States

Location

Related Publications (5)

  • 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.

    PMID: 26304968BACKGROUND
  • 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.

    PMID: 26304976BACKGROUND
  • 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(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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guadalupe X Ayala, PhD, MPH

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

September 1, 2017

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations