Understanding and Improving Diabetes Care for Ethnic Minorities (R2D2C2)
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|ClinicalTrials.gov Identifier: NCT01123239|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Coached Care Behavioral: Standard Diabetes Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Reducing Racial Disparities in Diabetes Care - The Coached Care Study|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2013|
Experimental: 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.
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.
Active Comparator: 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.
Behavioral: 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
- Hemoglobin A1c [ Time Frame: 1 year and 2 year follow-up ]A laboratory measure of blood sugar control
- Health-related quality of life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123239
|United States, California|
|Mary and Dick Allen Diabetes Center at Hoag Hospital|
|Newport Beach, California, United States, 92663|
|University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|Westminster Medical Center|
|Westminster, California, United States, 92683|