Collaborative Care for Depression and Diabetic Retinopathy in African Americans

NCT ID: NCT02121340

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral Activation

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.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral Activation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wills Eye

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Rovner, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Robin Casten, PhD

Role: STUDY_DIRECTOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R34EY024299

Identifier Type: NIH

Identifier Source: org_study_id

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