Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02121340 |
Date of registration:
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21/04/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Collaborative Care for Depression and Diabetic Retinopathy in African Americans
CC-DDR |
Scientific title:
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Collaborative Care for Depression and Diabetic Retinopathy in African Americans |
Date of first enrolment:
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May 2014 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02121340 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Robin Casten, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson University |
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Name:
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Barry Rovner, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Diabetic Retinopathy
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Intervention(s)
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Behavioral: Behavioral Activation
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Primary Outcome(s)
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Hemoglobin A1c
[Time Frame: 12 months]
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Secondary ID(s)
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R34EY024299
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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