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Completed

NCT Number: NCT02121340

Collaborative Care for Depression and Diabetic Retinopathy in African Americans

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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About this study

The Specific Aims are:

  • To develop the CC-DDR treatment protocol. This will involve:
  • Creating an initial version of the CC-DDR treatment protocol.
  • 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.
  • Developing a tool to assess interventionist treatment adherence and competence.
  • 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:
  • Evaluate the feasibility of CC-DDR.
  • Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel.
  • 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.
  • 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.
  • To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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

Treatment and study plan

Behavioral Activation

Behavioral

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 12 months

    Change in hemoglobin A1c from baseline to 12 months

Other outcomes

  1. Depression

    Time frame: 12 months

    Improvement in depressive symptoms from baseline to 12 months

  2. Progression of diabetic retinopathy

    Time frame: Baseline to 12 months

  3. Diabetes self management

    Time frame: 12 months

    Improvement from baseline to 12 months

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Wills Eye

Registry information

Acronym: CC-DDR

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 23, 2014
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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