Collaborative Care for Depression and Diabetic Retinopathy in African Americans



Status:Completed
Conditions:Depression, Depression, Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology, Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:2/23/2019
Start Date:May 2014
End Date:December 2018

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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:

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.

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
We found this trial at
2
sites
Philadelphia, Pennsylvania 19107
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Barry Rovner, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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