Clinical trial NCT00390286: Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC
Official title: Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Keywords: Telemedicine
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute stroke patients

Brief summary: This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a telemedicine system for performing research in a remote hospital system.

Detailed description: The UCSD Telemedicine system is a digital video camera system, which can transfer video and audio images from a clinic or emergency room to a remote place where a physician can review images in real time (as they happen). The system uses site independent software to access the camera system from multiple locations. This research study will determine if it is feasible to obtain informed consent for various types of research trials (hypothetical, non-invasive, invasive trails) via telemedicine. Inpatient assessments on participants to complete clinical research case report forms by telemedicine will also by performed.

Eligibility criteria: Inclusion Criteria:

* Male/Female, age 18 years or older
* Clinical neurological focal deficits consistent with stroke
* Time of onset 3-24 hours and with stable neurological deficit
* Signed Informed Consent

Exclusion Criteria:

* Deficits known to be due to non-stroke etiology
* Time of onset less than 3 hours
* Patients unable to give consent

Primary outcomes:
measure: Number of trials participant is enrolled into
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Stroke Center
state: California
Study officials:
affiliation: UCSD Medical Center
name: Brett C. Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer BC, Lyden PD, Al-Khoury L, Cheng Y, Raman R, Fellman R, Beer J, Rao R, Zivin JA. Prospective reliability of the STRokE DOC wireless/site independent telemedicine system. Neurology. 2005 Mar 22;64(6):1058-60. doi: 10.1212/01.WNL.0000154601.26653.E7.
citation: LaMonte MP, Bahouth MN, Hu P, Pathan MY, Yarbrough KL, Gunawardane R, Crarey P, Page W. Telemedicine for acute stroke: triumphs and pitfalls. Stroke. 2003 Mar;34(3):725-8. doi: 10.1161/01.STR.0000056945.36583.37. Epub 2003 Jan 30.
citation: Levine SR, Gorman M. "Telestroke" : the application of telemedicine for stroke. Stroke. 1999 Feb;30(2):464-9. doi: 10.1161/01.str.30.2.464.
citation: Audebert HJ, Kukla C, Clarmann von Claranau S, Kuhn J, Vatankhah B, Schenkel J, Ickenstein GW, Haberl RL, Horn M; TEMPiS Group. Telemedicine for safe and extended use of thrombolysis in stroke: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria. Stroke. 2005 Feb;36(2):287-91. doi: 10.1161/01.STR.0000153015.57892.66. Epub 2004 Dec 29.
citation: Wiborg A, Widder B; Telemedicine in Stroke in Swabia Project. Teleneurology to improve stroke care in rural areas: The Telemedicine in Stroke in Swabia (TESS) Project. Stroke. 2003 Dec;34(12):2951-6. doi: 10.1161/01.STR.0000099125.30731.97. Epub 2003 Nov 20.
citation: Wang S, Gross H, Lee SB, Pardue C, Waller J, Nichols FT 3rd, Adams RJ, Hess DC. Remote evaluation of acute ischemic stroke in rural community hospitals in Georgia. Stroke. 2004 Jul;35(7):1763-8. doi: 10.1161/01.STR.0000131858.63829.6e. Epub 2004 May 27.
citation: Meyer BC, Raman R, Chacon MR, Jensen M, Werner JD. Reliability of site-independent telemedicine when assessed by telemedicine-naive stroke practitioners. J Stroke Cerebrovasc Dis. 2008 Jul-Aug;17(4):181-6. doi: 10.1016/j.jstrokecerebrovasdis.2008.01.008.