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OpenTrials
Completed

NCT Number: NCT01123239

Understanding and Improving Diabetes Care for Ethnic Minorities

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mary and Dick Allen Diabetes Center at Hoag Hospital, Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coached Care

Behavioral

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.

Standard Diabetes Education

Behavioral

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 outcomes

  1. Hemoglobin A1c

    Time frame: 1 year and 2 year follow-up

    A laboratory measure of blood sugar control

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Reducing Racial Disparities in Diabetes Care - The Coached Care Study

Acronym: R2D2C2

Important dates

Study start
2006
Primary completion
2012
Study completion
2013
First posted
May 14, 2010
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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