Understanding and Improving Diabetes Care for Ethnic Minorities

Study Overview
=================
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.

Official Title
-----------------
Reducing Racial Disparities in Diabetes Care - The Coached Care Study

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Coached Care
* Behavioral: Standard Diabetes Education


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coached Care<br>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<br>* 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.<br>|
| Active Comparator: Standard Diabetes Education<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | A laboratory measure of blood sugar control | 1 year and 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others. | 1 year and 2 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare Disparities