Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC)
This study has been completed.
Sponsors and Collaborators: University of California, San Diego
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00283868
  Purpose

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.


Condition
Stroke

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: A Phase I, Prospective Study to Evaluate the Feasibility, Reliability, and Validity of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Appropriateness of decision to treat or not treat with thrombolytics [ Time Frame: potentially within 3 hours of symptom onset ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ICH rate (post rt-PA) [ Time Frame: potentially within 3 hours of symptom onset ] [ Designated as safety issue: Yes ]
  • Number of thrombolytic administrations [ Time Frame: potentially within 3 hours of symptom onset ] [ Designated as safety issue: No ]
  • Time to treatment decision for administration of thrombolytics [ Time Frame: potentially within 3 hours of symptom onset ] [ Designated as safety issue: No ]
  • Technical observations [ Time Frame: Time of consultation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: January 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283868

Locations
United States, California
University of California San Diego
San Diego, California, United States
Pioneers Memorial Hospital
Brawley, California, United States
El Centro Regional Medical Center
El Centro, California, United States
Twin Cities Community Hospital
San Luis Obispo, California, United States
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brett Meyer, MD UCSD Stroke Center
  More Information

Publications:
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.
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. Epub 2003 Sep 18. No abstract available.
Patterson V. Teleneurology. J Telemed Telecare 2005;11(2):55-59.
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.
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.
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. Epub 2004 Dec 29.
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.
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.

Publications indexed to this study:
Responsible Party: UCSD Stroke Center ( Brett Meyer, MD, UCSD Department of Neurology )
Study ID Numbers: P50NS44148MEYER, P50NS44148
Study First Received: January 26, 2006
Last Updated: December 26, 2007
ClinicalTrials.gov Identifier: NCT00283868  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke
digital video
SPOTRIAS

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009