Participatory Design of Patient-centered Depression and Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Depression: nine-item Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •a current diagnosis of Type 2 DM
- •current prescription for an oral hypoglycemic agent
- •able to communicate in English
- •willing to give informed consent
排除标准
- •acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately)
- •significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21)
- •markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)
结局指标
主要结局
Depression: nine-item Patient Health Questionnaire (PHQ-9)
时间窗: Baseline and 14 weeks
Glycemic control: hemoglobin A1c
时间窗: Baseline and 14 weeks
Adherence to oral hypoglycemic agents: Medication Event Monitoring System
时间窗: Over 14 weeks
次要结局
未报告次要终点
研究者
Hillary Bogner
Associate Professor
University of Pennsylvania