Diabetes Mellitus, Type 2
Conditions
Keywords
Healthcare Disparities
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.
Interventions
BEHAVIORALCoached 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.
BEHAVIORALStandard 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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 1 year and 2 year follow-up | A laboratory measure of blood sugar control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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. |
Countries
United States
Outcome results
None listed