Understanding and Improving Diabetes Care for Ethnic Minorities

Diabetes Mellitus, Type 2 Clinical Trial

— R2D2C2  

Official title:

Reducing Racial Disparities in Diabetes Care - The Coached Care Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123239
• Other study ID #: HS# 2004-4025
• Secondary ID: R18DK069846K01DK
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: May 26, 2015
• Start date: January 2006
• Est. completion date: March 2013

Study information

• Verified date: May 2015
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Coached Care
Coached Care pairs patients with linguistically and ethnically matched peer "coaches", who themselves have diabetes, and have been trained to meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Using a decision tree algorithm, they help patients identify relevant questions about symptoms, barriers to self-management and treatment options to discuss with doctor. They encourage mutual decision-making about tailoring the patient's medication regimen, diet and physical activities and work with the patients to overcome barriers to communication with their doctor. After the medical visit, the coach and patient review any treatment decisions and goals for self-care.
• Standard Diabetes Education
Patients randomized to the control group will receive 20 minutes of standardized diabetes education delivered by staff research assistants. Education materials have been adapted from materials developed by the American Diabetes Association. The content of these materials includes information about the causes and complications of diabetes, as well as ways to reduce complication risks. Patients in the control arm will receive 20 minutes of standardized diabetes education before each visit

Locations

Country	Name	City	State
United States	Mary and Dick Allen Diabetes Center at Hoag Hospital	Newport Beach	California
United States	University of California Irvine Medical Center	Orange	California
United States	Westminster Medical Center	Westminster	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	A laboratory measure of blood sugar control	1 year and 2 year follow-up	No
Secondary	Health-related quality of life	Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.	1 year and 2 year follow-up	No

External Links

•   Homepage for the Reducing Racial Disparities in Diabetes Coached Care Study at UCI