Understanding and Improving Diabetes Care for Ethnic Minorities (R2D2C2)

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014