Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00283868
First received: January 26, 2006
Last updated: November 18, 2009
Last verified: September 2009

January 26, 2006
November 18, 2009
January 2004
August 2007   (final data collection date for primary outcome measure)
Appropriateness of Decision to Treat or Not Treat With Thrombolytics [ Time Frame: potentially within 3 hours of symptom onset ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00283868 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Intracerebral Hemorrhage (ICH) [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
  • Percentage of Total 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 ]
  • Percentage of Evaluations With Technical Observations [ Time Frame: Time of consultation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Stroke Team Remote Evaluation Using a Digital Observation Camera
A Prospective Study to Evaluate the Efficacy of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Acute Stroke Patients

Stroke
Not Provided
  • Telemedicine
    Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
  • Telephone
    Patients randomized to this group were evaluated using telephone only and no use of the digital observation camera or DICOM

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283868
P50NS44148MEYER, P50NS44148
Yes
Brett C. Meyer, MD, UCSD Department of Neurology, UCSD Stroke Center
University of California, San Diego
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Brett Meyer, MD UCSD Stroke Center
University of California, San Diego
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP