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Understanding and Improving Diabetes Care for Ethnic Minorities (R2D2C2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coached Care
Standard Diabetes Education
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Healthcare Disparities

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mary and Dick Allen Diabetes Center at Hoag Hospital
  • University of California Irvine Medical Center
  • Westminster Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coached Care

Standard Diabetes Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
A laboratory measure of blood sugar control

Secondary Outcome Measures

Health-related quality of life
Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.

Full Information

First Posted
May 12, 2010
Last Updated
May 26, 2015
Sponsor
University of California, Irvine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01123239
Brief Title
Understanding and Improving Diabetes Care for Ethnic Minorities
Acronym
R2D2C2
Official Title
Reducing Racial Disparities in Diabetes Care - The Coached Care Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Healthcare Disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coached Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Diabetes Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coached Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Diabetes Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
A laboratory measure of blood sugar control
Time Frame
1 year and 2 year follow-up
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.
Time Frame
1 year and 2 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mary and Dick Allen Diabetes Center at Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Westminster Medical Center
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23047130
Citation
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.
Results Reference
derived
PubMed Identifier
21273497
Citation
Sorkin 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.
Results Reference
derived
Links:
URL
http://www.medicine.uci.edu/r2d2c2/
Description
Homepage for the Reducing Racial Disparities in Diabetes Coached Care Study at UCI

Learn more about this trial

Understanding and Improving Diabetes Care for Ethnic Minorities

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