Informatics for Diabetes Education and Telemedicine (IDEATel)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Columbia University
- Enrollment
- 1665
- Locations
- 2
- Primary Endpoint
- Hemoglobin A1c Levels
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Moderate or severe cognitive, visual, or physical impairment
- •The presence of severe co-morbid disease.
Outcomes
Primary Outcomes
Hemoglobin A1c Levels
Time Frame: 5 years
Blood Pressure Levels
Time Frame: 5 years
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
Time Frame: 5 years