Randomized Trial of Telemedicine for Diabetes Care (IDEATel)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Informatics for Diabetes Education and Telemedicine (IDEATel)|
- Hemoglobin A1c Levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Blood Pressure Levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2000|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Telemedicine case management
Telemedicine visits conducted by a registered nurse (RN) with remote monitoring of blood pressure (BP) and blood glucose through the use of a telemedicine home unit (HTU).
Device: Telemedicine Unit (HTU)
This study involves the deployment of a home telemedicine unit (HTU). The HTU provides 3 critical functions for patients: videoconferencing, access to information resources and e-mail through a web-enabled workstation, and medical data acquisition through an electronic device interface. The HTUs also included a glucometer and a blood pressure cuff interfaced directly with the HTU.
Other Name: HTU
Active Comparator: Usual care
usual care by primary care provider
Other: usual care
usual diabetes care, as provided by primary care providers
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271739
|United States, New York|
|New York, New York, United States, 10032|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Steven Shea, MD||Columbia University|