NCT00271739

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,665

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

August 10, 2011

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

6.4 years

First QC Date

December 30, 2005

Results QC Date

February 28, 2011

Last Update Submit

August 29, 2023

Conditions

Diabetes Mellitus

Keywords

TelemedicineDiabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin A1c Levels

    5 years

  • Blood Pressure Levels

    5 years

  • Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol

    5 years

Study Arms (2)

Telemedicine case management

EXPERIMENTAL

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)

Usual care

ACTIVE COMPARATOR

usual care by primary care provider

Other: usual care

Interventions

Telemedicine Unit (HTU)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.

Also known as: HTU
Telemedicine case management
usual careOTHER

usual diabetes care, as provided by primary care providers

Usual care

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate or severe cognitive, visual, or physical impairment
  • The presence of severe co-morbid disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (17)

  • 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.

    PMID: 11751803BACKGROUND

  • 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.

    PMID: 11751801BACKGROUND

  • 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.

    PMID: 16221935RESULT

  • 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.

    PMID: 25439094DERIVED

  • 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.

    PMID: 23488491DERIVED

  • 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.

    PMID: 22762449DERIVED

  • 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.

    PMID: 21241171DERIVED

  • 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.

    PMID: 21081539DERIVED

  • 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.

    PMID: 21070978DERIVED

  • 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.

    PMID: 20507198DERIVED

  • 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.

    PMID: 20431360DERIVED

  • 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.

    PMID: 20190064DERIVED

  • 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.

    PMID: 19807952DERIVED

  • 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.

    PMID: 19780691DERIVED

  • 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.

    PMID: 19390093DERIVED

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

    PMID: 18528511DERIVED

  • 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.

    PMID: 17325261DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Walter Palmas, M.D.
Organization
Columbia University
wp56@columbia.edu
212-305-3163

Study Officials

  • Steven Shea, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hamilton Southworth Professor of Medicine and Professor of Epidemiology (in Biomedical Informatics); Senior Vice Dean , College of Physicians and Surgeons

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

December 1, 2000

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 18, 2023

Results First Posted

August 10, 2011

Record last verified: 2023-08

Locations

US(2)