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Randomized Trial of Telemedicine for Diabetes Care (IDEATel)

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ClinicalTrials.gov Identifier: NCT00271739
Recruitment Status : Completed
First Posted : January 4, 2006
Results First Posted : August 10, 2011
Last Update Posted : November 22, 2012
Sponsor:
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Steven J. Shea, Columbia University

December 30, 2005
January 4, 2006
February 28, 2011
August 10, 2011
November 22, 2012
December 2000
May 2007   (Final data collection date for primary outcome measure)
  • 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 ]
  • Hemoglobin A1c Levels
  • Blood Pressure Levels
  • Serum lipids levels
Complete list of historical versions of study NCT00271739 on ClinicalTrials.gov Archive Site
Not Provided
  • Cost-effectiveness
  • Acceptablity of telemedicine
Not Provided
Not Provided
 
Randomized Trial of Telemedicine for Diabetes Care
Informatics for Diabetes Education and Telemedicine (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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Diabetes Mellitus
  • 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
  • Other: usual care
    usual diabetes care, as provided by primary care providers
  • 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).
    Intervention: Device: Telemedicine Unit (HTU)
  • Active Comparator: Usual care
    usual care by primary care provider
    Intervention: Other: usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1665
Same as current
May 2007
May 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00271739
AAAA5372
CMS 95-C-90998 ( Other Identifier: protocol )
Yes
Not Provided
Not Provided
Steven J. Shea, Columbia University
Columbia University
State University of New York - Upstate Medical University
Principal Investigator: Steven Shea, MD Columbia University
Columbia University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP