Clinical trial NCT00271739: Randomized Trial of Telemedicine for Diabetes Care
Official title: Informatics for Diabetes Education and Telemedicine (IDEATel)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Telemedicine
Diabetes Mellitus
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: State University of New York - Upstate Medical University
First posted: 2006-01-04
Enrollment: 1665
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Hemoglobin A1c Levels
timeFrame: 5 years
measure: Blood Pressure Levels
timeFrame: 5 years
measure: Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: Columbia University
name: Steven Shea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Shea S; IDEATel Consortium. The Informatics for Diabetes and Education Telemedicine (IDEATel) project. Trans Am Clin Climatol Assoc. 2007;118:289-304.
citation: 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.