Collaborative Care for Depression and Diabetic Retinopathy in African Americans

NCT02121340 | Completed

• 1 other identifier: R34EY024299
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Retinopathy

Keywords

Depression; Health disparities; African American; Geriatric

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Change in hemoglobin A1c from baseline to 12 months

  12 months

Other Outcomes (3)

• Depression

  12 months

• Progression of diabetic retinopathy

  Baseline to 12 months

• Diabetes self management

  12 months

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual Care

Interventions

Behavioral Activation BEHAVIORAL

Behavioral Activation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• African-American race
• age ≥ 65 years
• type 2 diabetes
• mild or moderate nonproliferative DR with or without macular edema
• depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5)
• HbA1C ≥ 7.0%

You may not qualify if:

• treated proliferative DR
• global cognitive impairment (i.e., Mini Mental Status score ≤ 20)
• psychiatric diagnosis other than depression
• treatment for depression started in the previous 3 months
• life expectancy under 2 years

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Wills Eye: collaborator

Study Sites (2)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Depression

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Barry Rovner, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Robin Casten, PhD

  Thomas Jefferson University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

US (2)