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Randomized Trial of Telemedicine for Diabetes Care (IDEATel)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271739
First Posted: January 4, 2006
Last Update Posted: November 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Steven J. Shea, Columbia University
  Purpose
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.

Condition Intervention
Diabetes Mellitus Device: Telemedicine Unit (HTU) Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Informatics for Diabetes Education and Telemedicine (IDEATel)

Further study details as provided by Steven J. Shea, Columbia University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1665
Study Start Date: December 2000
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271739


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Columbia University
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Steven Shea, MD Columbia University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00271739     History of Changes
Other Study ID Numbers: AAAA5372
CMS 95-C-90998 ( Other Identifier: protocol )
First Submitted: December 30, 2005
First Posted: January 4, 2006
Results First Submitted: February 28, 2011
Results First Posted: August 10, 2011
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by Steven J. Shea, Columbia University:
Telemedicine
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases