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Randomized Trial of Telemedicine for Diabetes Care (IDEATel)

This study has been completed.
Sponsor:
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Steven J. Shea, Columbia University
ClinicalTrials.gov Identifier:
NCT00271739
First received: December 30, 2005
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Informatics for Diabetes Education and Telemedicine (IDEATel)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Additional 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
Study First Received: December 30, 2005
Results First Received: February 28, 2011
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Telemedicine
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on May 23, 2013