Understanding and Improving Diabetes Care for Ethnic Minorities

NCT ID: NCT01123239

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Coached Care

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Standard Diabetes Education

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Sheldon Greenfield

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mary and Dick Allen Diabetes Center at Hoag Hospital

Newport Beach, California, United States

Site Status

University of California Irvine Medical Center

Orange, California, United States

Site Status

Westminster Medical Center

Westminster, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23047130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21273497 (View on PubMed)

Related Links

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http://www.medicine.uci.edu/r2d2c2/

Homepage for the Reducing Racial Disparities in Diabetes Coached Care Study at UCI

Other Identifiers

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R18DK069846

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K01DK078939

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS# 2004-4025

Identifier Type: -

Identifier Source: org_study_id

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