Randomized Trial of Telemedicine for Diabetes Care - Full Text View

Sponsors and Collaborators:	Columbia University State University of New York - Upstate Medical University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00271739

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	Procedure: Telemedicine diabetes case management

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Informatics for Diabetes Education and Telemedicine (IDEATel)

Further study details as provided by Columbia University:

Primary Outcome Measures:

Hemoglobin A1c levels
Blood pressure levels
Serum lipids levels

Secondary Outcome Measures:

Cost-effectiveness
Acceptablity of telemedicine

Estimated Enrollment:	1665
Study Start Date:	December 2000
Estimated Study Completion Date:	February 2008

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 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:

Criteria for inclusion were 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, and fluency in either English or Spanish.

Exclusion Criteria:

Exclusions were moderate or severe cognitive, visual, or physical impairment, or the presence of severe comorbid 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

study website This link exits the ClinicalTrials.gov site

Publications of Results:

Shea S, Weinstock RS, Starren J, Teresi J, Palmas W, Field L, Morin P, Goland R, Izquierdo RE, Wolff LT, Ashraf M, Hilliman C, Silver S, Meyer S, Holmes D, Petkova E, Capps L, Lantigua RA. A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus. J Am Med Inform Assoc. 2006 January-February;13(1):40-51. Epub 2005 Oct 12.

Other Publications:

Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, Palmas W, Field L, Goland R, Tuck C, Hripcsak G, Capps L, Liss D. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):49-62.

Starren J, Hripcsak G, Sengupta S, Abbruscato CR, Knudson PE, Weinstock RS, Shea S. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) project: technical implementation. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):25-36.

Publications indexed to this study:

Shea S; IDEATel Consortium. The Informatics for Diabetes and Education Telemedicine (IDEATel) project. Trans Am Clin Climatol Assoc. 2007;118:289-304.

Trief PM, Teresi JA, Izquierdo R, Morin PC, Goland R, Field L, Eimicke JP, Brittain R, Starren J, Shea S, Weinstock RS. Psychosocial outcomes of telemedicine case management for elderly patients with diabetes: the randomized IDEATel trial. Diabetes Care. 2007 May;30(5):1266-8. Epub 2007 Feb 26. No abstract available.

Study ID Numbers:	CMS 95-C-90998
Study First Received:	December 30, 2005
Last Updated:	October 3, 2007
ClinicalTrials.gov Identifier:	NCT00271739
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Telemedicine
Diabetes Mellitus

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009