Randomized Trial of Telemedicine for Diabetes Care

NCT ID: NCT00271739

Last Updated: 2023-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Telemedicine Unit (HTU)

Intervention Type DEVICE

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.

Usual care

usual care by primary care provider

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

usual diabetes care, as provided by primary care providers

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

usual care

usual diabetes care, as provided by primary care providers

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HTU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York - Upstate Medical University

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven J. Shea

Hamilton Southworth Professor of Medicine and Professor of Epidemiology (in Biomedical Informatics); Senior Vice Dean , College of Physicians and Surgeons

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Shea, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1136/jamia.2002.0090049.

Reference Type BACKGROUND
PMID: 11751803 (View on PubMed)

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. doi: 10.1136/jamia.2002.0090025.

Reference Type BACKGROUND
PMID: 11751801 (View on PubMed)

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 Jan-Feb;13(1):40-51. doi: 10.1197/jamia.M1917. Epub 2005 Oct 12.

Reference Type RESULT
PMID: 16221935 (View on PubMed)

Palta P, Golden SH, Teresi J, Palmas W, Weinstock RS, Shea S, Manly JJ, Luchsinger JA. Mild cognitive dysfunction does not affect diabetes mellitus control in minority elderly adults. J Am Geriatr Soc. 2014 Dec;62(12):2363-8. doi: 10.1111/jgs.13129. Epub 2014 Nov 29.

Reference Type DERIVED
PMID: 25439094 (View on PubMed)

Shea S, Kothari D, Teresi JA, Kong J, Eimicke JP, Lantigua RA, Palmas W, Weinstock RS. Social impact analysis of the effects of a telemedicine intervention to improve diabetes outcomes in an ethnically diverse, medically underserved population: findings from the IDEATel Study. Am J Public Health. 2013 Oct;103(10):1888-94. doi: 10.2105/AJPH.2012.300909. Epub 2013 Mar 14.

Reference Type DERIVED
PMID: 23488491 (View on PubMed)

Trief PM, Izquierdo R, Eimicke JP, Teresi JA, Goland R, Palmas W, Shea S, Weinstock RS. Adherence to diabetes self care for white, African-American and Hispanic American telemedicine participants: 5 year results from the IDEATel project. Ethn Health. 2013;18(1):83-96. doi: 10.1080/13557858.2012.700915. Epub 2012 Jul 5.

Reference Type DERIVED
PMID: 22762449 (View on PubMed)

Remler DK, Teresi JA, Weinstock RS, Ramirez M, Eimicke JP, Silver S, Shea S. Health care utilization and self-care behaviors of Medicare beneficiaries with diabetes: comparison of national and ethnically diverse underserved populations. Popul Health Manag. 2011 Feb;14(1):11-20. doi: 10.1089/pop.2010.0003. Epub 2011 Jan 17.

Reference Type DERIVED
PMID: 21241171 (View on PubMed)

Weinstock RS, Brooks G, Palmas W, Morin PC, Teresi JA, Eimicke JP, Silver S, Izquierdo R, Goland R, Shea S. Lessened decline in physical activity and impairment of older adults with diabetes with telemedicine and pedometer use: results from the IDEATel study. Age Ageing. 2011 Jan;40(1):98-105. doi: 10.1093/ageing/afq147. Epub 2010 Nov 16.

Reference Type DERIVED
PMID: 21081539 (View on PubMed)

Homenko DR, Morin PC, Eimicke JP, Teresi JA, Weinstock RS. Food insecurity and food choices in rural older adults with diabetes receiving nutrition education via telemedicine. J Nutr Educ Behav. 2010 Nov-Dec;42(6):404-9. doi: 10.1016/j.jneb.2009.08.001.

Reference Type DERIVED
PMID: 21070978 (View on PubMed)

West SP, Lagua C, Trief PM, Izquierdo R, Weinstock RS. Goal setting using telemedicine in rural underserved older adults with diabetes: experiences from the informatics for diabetes education and telemedicine project. Telemed J E Health. 2010 May;16(4):405-16. doi: 10.1089/tmj.2009.0136.

Reference Type DERIVED
PMID: 20507198 (View on PubMed)

Robinson KS, Morin PC, Shupe JA, Izquierdo R, Ploutz-Snyder R, Meyer S, Teresi JA, Starren J, Shea S, Weinstock RS. Use of three computer training methods in elderly underserved rural patients enrolled in a diabetes telemedicine program. Comput Inform Nurs. 2010 May-Jun;28(3):172-7. doi: 10.1097/NCN.0b013e3181d785d5.

Reference Type DERIVED
PMID: 20431360 (View on PubMed)

Palmas W, Shea S, Starren J, Teresi JA, Ganz ML, Burton TM, Pashos CL, Blustein J, Field L, Morin PC, Izquierdo RE, Silver S, Eimicke JP, Lantigua RA, Weinstock RS; IDEATel Consortium. Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel). J Am Med Inform Assoc. 2010 Mar-Apr;17(2):196-202. doi: 10.1136/jamia.2009.002592.

Reference Type DERIVED
PMID: 20190064 (View on PubMed)

Morin PC, Wolff LT, Eimicke JP, Teresi JA, Shea S, Weinstock RS. Record media used by primary care providers in medically underserved regions of upstate New York was not pivotal to clinical result in the Informatics for Diabetes Education and Telemedicine (IDEATel) project. Inform Prim Care. 2009;17(2):103-12. doi: 10.14236/jhi.v17i2.722.

Reference Type DERIVED
PMID: 19807952 (View on PubMed)

Sandberg J, Trief PM, Izquierdo R, Goland R, Morin PC, Palmas W, Larson CD, Strait JG, Shea S, Weinstock RS. A qualitative study of the experiences and satisfaction of direct telemedicine providers in diabetes case management. Telemed J E Health. 2009 Oct;15(8):742-50. doi: 10.1089/tmj.2009.0027.

Reference Type DERIVED
PMID: 19780691 (View on PubMed)

Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.

Reference Type DERIVED
PMID: 19390093 (View on PubMed)

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

Reference Type DERIVED
PMID: 18528511 (View on PubMed)

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. doi: 10.2337/dc06-2476. Epub 2007 Feb 26. No abstract available.

Reference Type DERIVED
PMID: 17325261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMS 95-C-90998

Identifier Type: OTHER

Identifier Source: secondary_id

AAAA5372

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telenhealth and Adherence to Stains
NCT05872919 COMPLETED NA