Understanding and Improving Diabetes Care for Ethnic Minorities (R2D2C2)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Irvine
Collaborator:
Information provided by (Responsible Party):
Sheldon Greenfield, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01123239
First received: May 12, 2010
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Coached Care Behavioral: Standard Diabetes Education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Reducing Racial Disparities in Diabetes Care - The Coached Care Study |
Resource links provided by NLM:
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Hemoglobin A1c [ Time Frame: 1 year and 2 year follow-up ] [ Designated as safety issue: No ]A laboratory measure of blood sugar control
Secondary Outcome Measures:
- Health-related quality of life [ Time Frame: 1 year and 2 year follow-up ] [ Designated as safety issue: No ]Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.
| Estimated Enrollment: | 900 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123239
Locations
| 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 | |
Sponsors and Collaborators
University of California, Irvine
More Information
Additional Information:
No publications provided by University of California, Irvine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sheldon Greenfield, Professor, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT01123239 History of Changes |
| Other Study ID Numbers: | HS# 2004-4025, R18DK069846, K01DK078939 |
| Study First Received: | May 12, 2010 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Healthcare Disparities |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013