Collaborative Care for Depression and Diabetic Retinopathy in African Americans (CC-DDR)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Behavioral: Behavioral Activation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: 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.	Behavioral: Behavioral Activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Change in hemoglobin A1c from baseline to 12 months	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Improvement in depressive symptoms from baseline to 12 months	12 months
Progression of diabetic retinopathy		Baseline to 12 months
Diabetes self management	Improvement from baseline to 12 months	12 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Wills Eye
• Investigators: Principal Investigator: Barry Rovner, MD, Thomas Jefferson University; Study Director: Robin Casten, PhD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Depression; African American; Geriatric; Health disparities
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Depression; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: R34EY024299 (U.S. NIH Grant/Contract)