University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change From Baseline in Hemoglobin A1c at 6 Months
研究概览
简要总结
In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.
详细描述
The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.
The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Latino men and women age 50 and older
- •Must speak English or Spanish
- •Hb A1c greater than or equal to 8%
- •Currently not taking medication for depression
- •A score of 5 or greater on the Geriatric Depression Scale (GDS)
排除标准
- •Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident
- •Do not have sufficient hearing or cognitive function
结局指标
主要结局
Change From Baseline in Hemoglobin A1c at 6 Months
时间窗: Baseline and 6 months
Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Change From Baseline in Depression Measures at 6 Months
时间窗: Baseline and 6 months
The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression. The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression.
次要结局
- Change From Baseline in Blood Pressure at 6 Months(Baseline and 6 months)
- Change From Baseline in Low Density Lipoprotein-C at 6 Months(Baseline and 6 months)
- Change From Baseline in EQ-5D at 6 Months(Baseline and 6 months)
- Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months(Baseline and 6 months)
- Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months(Baseline and 6 months)
研究者
Dr. Jeanne Miranda
Jeanne Miranda Ph.D.
University of California, Los Angeles