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

NCT ID: NCT00390286

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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Telemedicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Brett Meyer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brett C. Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Medical Center

Locations

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UCSD Stroke Center

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15781827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12624298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9933289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15625294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14631092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15166386 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18589337 (View on PubMed)

Other Identifiers

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051010

Identifier Type: -

Identifier Source: org_study_id