Understanding and Improving Diabetes Care for Ethnic Minorities

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Coached Care; Behavioral: Standard Diabetes Education

• Registration Number: NCT01123239
• Lead Sponsor: University of California, Irvine

Brief Summary

In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• diagnosis of type 2 diabetes
• At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.

Exclusion Criteria

• Age above 80 years
• patients with dementia or other serious mental health problems that would prevent them from participating in the intervention.
• patients with other serious medical problems that would prevent them from participating in the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coached Care	Coached Care	Coached Care pairs patients with linguistically and ethnically matched peer "coaches" who have been trained to promote patient participation in the medical visit. The coaches, who themselves have diabetes, meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making.
Standard Diabetes Education	Standard Diabetes Education	Patients receive one-on-one diabetes education sessions before each medical visit. These sessions are purely informational, and do not include the specific patient activation components of the coached care intervention.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	1 year and 2 year follow-up	A laboratory measure of blood sugar control

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	1 year and 2 year follow-up	Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.

Trial Locations

Locations (3)

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

Mary and Dick Allen Diabetes Center at Hoag Hospital; 🇺🇸 Newport Beach, California, United States

Westminster Medical Center; 🇺🇸 Westminster, California, United States