NCT02121340

Collaborative Care for Depression and Diabetic Retinopathy in African Americans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Activation

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-04-23
• Last updated: 2019-02-21

Locations

2 sites across 1 country: United States