Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

Stroke Clinical Trial

Official title:

Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00390286
• Other study ID #: 051010
• Status: Withdrawn
• Phase: Phase 1
• First received: October 18, 2006
• Last updated: October 24, 2016
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: October 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United States	UCSD Stroke Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (6)

Audebert HJ, Kukla C, Clarmann von Claranau S, Kühn 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. Epub 2004 Dec 29. — View 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. Epub 2003 Jan 30. — View Citation

Levine SR, Gorman M. "Telestroke" : the application of telemedicine for stroke. Stroke. 1999 Feb;30(2):464-9. Review. — View 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. — View 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. Epub 2004 May 27. — View 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. Epub 2003 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of trials participant is enrolled into	Counting how many patients are enrolled into OTHER clinical trials using a telemedicine technique	5 years	No