Informatics for Diabetes Education and Telemedicine (IDEATel)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,665
- 试验地点
- 3
- 主要终点
- Hemoglobin A1c Levels
研究概览
简要总结
The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.
详细描述
The project is designed as a randomized controlled trial with approximately 750 subjects receiving a telemedicine intervention and approximately 750 receiving usual care. Eligibility requires having diabetes, being a Medicare beneficiary, and living in a medically underserved area. The project is conducted in New York City, in northern Manhattan (urban component), and in rural upstate New York through a consortion of participating institutions based at the State University of New York (SUNY) Upstate Medical University at Syracuse (rural component). Subjects are randomized to receive telemedicine case management or usual care for diabetes. The intervention utilizes a home telemedicine unit (HTU). The HTU is a specially designed, web-enabled device with a data port connected to a home glucometer and home blood pressure cuff whereby measurements obtained with these devices can be directly uploaded to a computer database. A diabetes nurse case manager interacts regularly with intervention participants through videoconference via the HTU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 years or greater
- •Being a current Medicare beneficiary (verified by the Centers for Medicare and Medicaid Services)
- •Having diabetes mellitus as defined by a physician's diagnosis and being on treatment with diet, an oral hypoglycemic agent, or insulin
- •Residence in a federally designated medically underserved area (either of two federal designations, Medically Underserved Area [MUA] or Health Manpower Shortage Area [HPSA]) in New York Sate
- •Fluency in either English or Spanish
排除标准
- •Moderate or severe cognitive, visual, or physical impairment
- •The presence of severe co-morbid disease.
结局指标
主要结局
Hemoglobin A1c Levels
时间窗: 5 years
Blood Pressure Levels
时间窗: 5 years
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
时间窗: 5 years
次要结局
未报告次要终点
研究者
Steven J. Shea
Hamilton Southworth Professor of Medicine and Professor of Epidemiology (in Biomedical Informatics); Senior Vice Dean , College of Physicians and Surgeons
Columbia University