Randomized Trial of Telemedicine for Diabetes Care (IDEATel)

Columbia University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Telemedicine Unit (HTU); Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT00271739

CMS 95-C-90998 (Other Identifier)

AAAA5372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,665 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,665 participants in 2 patient groups

Telemedicine case management

Experimental group

Description:

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).

Treatment:

Device: Telemedicine Unit (HTU)

Usual care

Active Comparator group

Description:

usual care by primary care provider

Treatment:

Other: usual care