Collaborative Care for Depression and Diabetic Retinopathy in African Americans

Diabetic Retinopathy Clinical Trial

— CC-DDR  

Official title:

Collaborative Care for Depression and Diabetic Retinopathy in African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121340
• Other study ID #: R34EY024299
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Behavioral:
• Behavioral Activation

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Improvement in depressive symptoms from baseline to 12 months	12 months
Other	Progression of diabetic retinopathy		Baseline to 12 months
Other	Diabetes self management	Improvement from baseline to 12 months	12 months
Primary	Hemoglobin A1c	Change in hemoglobin A1c from baseline to 12 months	12 months