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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02121340
Date of registration: 21/04/2014
Prospective Registration: Yes
Primary sponsor: Thomas Jefferson University
Public title: Collaborative Care for Depression and Diabetic Retinopathy in African Americans CC-DDR
Scientific title: Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Date of first enrolment: May 2014
Target sample size: 40
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02121340
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Robin Casten, PhD
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Name:     Barry Rovner, MD
Address: 
Telephone:
Email:
Affiliation:  Thomas Jefferson University
Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diabetic Retinopathy
Intervention(s)
Behavioral: Behavioral Activation
Primary Outcome(s)
Hemoglobin A1c [Time Frame: 12 months]
Secondary Outcome(s)
Secondary ID(s)
R34EY024299
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Wills Eye
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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