Collaborative Care for Depression and Diabetic Retinopathy in African Americans
This trial is active, not recruiting.
|Sponsor||Thomas Jefferson University|
|Start date||May 2014|
|End date||December 2016|
|Trial size||40 participants|
|Trial identifier||NCT02121340, R34EY024299|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
time frame: 12 months
Male or female participants at least 65 years old.
Inclusion Criteria: 1. African-American race 2. age ≥ 65 years 3. type 2 diabetes 4. mild or moderate nonproliferative DR with or without macular edema 5. depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5) 6. HbA1C ≥ 7.0% Exclusion Criteria: 1. treated proliferative DR 2. global cognitive impairment (i.e., Mini Mental Status score ≤ 20) 3. psychiatric diagnosis other than depression 4. treatment for depression started in the previous 3 months 5. life expectancy under 2 years
|Official title||Collaborative Care for Depression and Diabetic Retinopathy in African Americans|
|Principal investigator||Barry Rovner, MD|
|Description||The Specific Aims are: 1. To develop the CC-DDR treatment protocol. This will involve: 1. Creating an initial version of the CC-DDR treatment protocol. 2. Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans. 3. Developing a tool to assess interventionist treatment adherence and competence. 2. 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: 1. Evaluate the feasibility of CC-DDR. 2. Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel. 3. Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel. 4. Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR. 3. To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.|
Call for more information