Stroke Team Remote Evaluation Using a Digital Observation Camera

NCT ID: NCT00283868

Last Updated: 2015-06-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.

Detailed Description

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The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) system is a digital video camera system that can transfer video and audio images from the clinic or emergency room to a distant (remote) place where a stroke specialist can review the images in real time (as they happen). This system uses site independent software to access the camera system from multiple locations. The study will determine if video consultation is superior to telephone consultation for remote evaluation or treatment of stroke patients, and the usefulness of this system in evaluating patients with suspected stroke symptoms. However, this method is being used in other fields of medicine for assistance in medical evaluations.

Participants will be randomly assigned to receive evaluation by either the video camera system or by telephone alone. For those assigned to the video camera system, the system will be activated and will record and transmit video and audio images to a stroke specialist located at a remote location. He/she may ask the participants questions relating to medical illnesses and current symptoms, and may also review laboratory tests and x-ray images using a computer, if available. The stroke specialist will also perform general physical and neurological examinations, which will take place by video camera with the assistance of a bedside physician who will perform the actual examinations.

For those participants assigned to the telephone-only consultation, the video system will not be activated, but the same procedure as above will be followed except the stroke specialist will not be able to see the participants or examine them using the video camera system. Participation in the study will last for the entire time the participants are in the hospital. Participants will be contacted by telephone by a study nurse 3 months post-stroke for a 10-minute interview regarding their current health. The total duration for individual participation is 3 months.

The study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Telemedicine

Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine

No interventions assigned to this group

Telephone

Patients randomized to this group were evaluated using telephone only and no use of the digital observation camera or DICOM

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Symptoms consistent with acute stroke (ischemic or hemorrhagic)
* Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

Exclusion Criteria

* Unlikely to complete study through 90-day follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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UCSD Stroke Center

Principal Investigators

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Brett Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Stroke Center

Locations

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Pioneers Memorial Hospital

Brawley, California, United States

Site Status

El Centro Regional Medical Center

El Centro, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

Twin Cities Community Hospital

San Luis Obispo, 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)

Crome O, Bahr M. Editorial comment--Remote evaluation of acute ischemic stroke: a reliable tool to extend tissue plasminogen activator use to community and rural stroke patients? Stroke. 2003 Oct;34(10):e191-2. doi: 10.1161/01.STR.0000095163.28915.B9. Epub 2003 Sep 18. No abstract available.

Reference Type BACKGROUND
PMID: 14500919 (View on PubMed)

Patterson V. Teleneurology. J Telemed Telecare. 2005;11(2):55-9. doi: 10.1258/1357633053499840.

Reference Type BACKGROUND
PMID: 15829048 (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)

Schwamm LH, Rosenthal ES, Hirshberg A, Schaefer PW, Little EA, Kvedar JC, Petkovska I, Koroshetz WJ, Levine SR. Virtual TeleStroke support for the emergency department evaluation of acute stroke. Acad Emerg Med. 2004 Nov;11(11):1193-7. doi: 10.1197/j.aem.2004.08.014.

Reference Type BACKGROUND
PMID: 15528584 (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)

Demaerschalk BM, Raman R, Ernstrom K, Meyer BC. Efficacy of telemedicine for stroke: pooled analysis of the Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) and STRokE DOC Arizona telestroke trials. Telemed J E Health. 2012 Apr;18(3):230-7. doi: 10.1089/tmj.2011.0116. Epub 2012 Mar 8.

Reference Type DERIVED
PMID: 22400970 (View on PubMed)

Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6.

Reference Type DERIVED
PMID: 18676180 (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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P50NS044148

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50NS44148MEYER

Identifier Type: -

Identifier Source: org_study_id

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