Collaborative Care for Depression and Diabetic Retinopathy in African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
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.
详细描述
The Specific Aims are:
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To develop the CC-DDR treatment protocol. This will involve:
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Creating an initial version of the CC-DDR treatment protocol.
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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.
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Developing a tool to assess interventionist treatment adherence and competence.
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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:
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Evaluate the feasibility of CC-DDR.
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Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel.
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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.
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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.
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To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
Usual Care
Usual Care
Behavioral Activation
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.
干预措施: Behavioral Activation (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 12 months
Change in hemoglobin A1c from baseline to 12 months
次要结局
未报告次要终点