Understanding and Improving Diabetes Care for Ethnic Minorities
R2D2C2
Reducing Racial Disparities in Diabetes Care - The Coached Care Study
3 other identifiers
interventional
540
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jan 2006
Longer than P75 for not_applicable diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2010
CompletedFirst Posted
Study publicly available on registry
May 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 27, 2015
May 1, 2015
6.2 years
May 12, 2010
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
A laboratory measure of blood sugar control
1 year and 2 year follow-up
Secondary Outcomes (1)
Health-related quality of life
1 year and 2 year follow-up
Study Arms (2)
Coached Care
EXPERIMENTALCoached 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
ACTIVE COMPARATORPatients 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- diagnosis of type 2 diabetes
- At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mary and Dick Allen Diabetes Center at Hoag Hospital
Newport Beach, California, 92663, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Westminster Medical Center
Westminster, California, 92683, United States
Related Publications (2)
Malik S, Billimek J, Greenfield S, Sorkin DH, Ngo-Metzger Q, Kaplan SH. Patient complexity and risk factor control among multimorbid patients with type 2 diabetes: results from the R2D2C2 study. Med Care. 2013 Feb;51(2):180-5. doi: 10.1097/MLR.0b013e318273119b.
PMID: 23047130DERIVEDSorkin DH, Ngo-Metzger Q, Billimek J, August KJ, Greenfield S, Kaplan SH. Underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes. Diabetes Care. 2011 Mar;34(3):598-600. doi: 10.2337/dc10-1825. Epub 2011 Jan 27.
PMID: 21273497DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 12, 2010
First Posted
May 14, 2010
Study Start
January 1, 2006
Primary Completion
March 1, 2012
Study Completion
March 1, 2013
Last Updated
May 27, 2015
Record last verified: 2015-05