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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283868
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : November 19, 2009
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of California, San Diego

Tracking Information
First Submitted Date January 26, 2006
First Posted Date January 30, 2006
Results First Submitted Date March 27, 2009
Results First Posted Date November 19, 2009
Last Update Posted Date June 3, 2015
Study Start Date January 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2015)
Appropriateness of Decision to Treat or Not Treat With Thrombolytics [ Time Frame: potentially within 3 hours of symptom onset ]
This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset. Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was "appropriate" to give or not give rt-PA.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00283868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 2, 2015)
  • Percentage of Participants With Intracerebral Hemorrhage (ICH) [ Time Frame: 36 hours ]
    Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.
  • Percentage of Total Thrombolytic Administrations [ Time Frame: potentially within 3 hours of symptom onset ]
    This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.
  • Time to Treatment Decision for Administration of Thrombolytics [ Time Frame: potentially within 3 hours of symptom onset ]
    time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.
  • Percentage of Evaluations With Technical Observations [ Time Frame: Time of consultation ]
    Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stroke Team Remote Evaluation Using a Digital Observation Camera
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
Brief Summary 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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Acute Stroke Patients
Condition Stroke
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2009)
234
Original Enrollment
 (submitted: January 26, 2006)
400
Actual Study Completion Date August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00283868
Other Study ID Numbers P50NS44148MEYER
P50NS044148 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Brett C. Meyer, MD, UCSD Department of Neurology, UCSD Stroke Center
Study Sponsor University of California, San Diego
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Brett Meyer, MD UCSD Stroke Center
PRS Account University of California, San Diego
Verification Date September 2009