Clinical trial NCT02121340: Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Official title: Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Depression
Health disparities
African American
Geriatric
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Wills Eye
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Depression
timeFrame: 12 months
measure: Progression of diabetic retinopathy
timeFrame: Baseline to 12 months
measure: Diabetes self management
timeFrame: 12 months
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Barry Rovner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Robin Casten, PhD
role: STUDY_DIRECTOR
References: