Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wills Eye | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.
The Specific Aims are:
To develop the CC-DDR treatment protocol. This will involve:
To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will:
To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation | Experimental | CC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills. |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Change in hemoglobin A1c from baseline to 12 months | 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Improvement in depressive symptoms from baseline to 12 months | 12 months |
| Progression of diabetic retinopathy | Baseline to 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barry Rovner, MD | Thomas Jefferson University | Principal Investigator |
| Robin Casten, PhD | Thomas Jefferson University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States | ||
| Wills Eye Hospital |
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diabetes self management | Improvement from baseline to 12 months | 12 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |