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
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

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: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 234
Study Start Date: January 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Sampling Method:   Probability Sample
Study Population

Acute Stroke Patients

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
Pioneers Memorial Hospital
Brawley, California, United States
El Centro Regional Medical Center
El Centro, California, United States
University of California San Diego
San Diego, 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:
Patterson V. Teleneurology. J Telemed Telecare 2005;11(2):55-59.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brett C. Meyer, MD, UCSD Department of Neurology, UCSD Stroke Center
ClinicalTrials.gov Identifier: NCT00283868     History of Changes
Other Study ID Numbers: P50NS44148MEYER, P50NS44148
Study First Received: January 26, 2006
Results First Received: March 27, 2009
Last Updated: November 18, 2009
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
stroke
digital video
SPOTRIAS

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 14, 2014