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Completed

NCT Number: NCT00283868

Stroke Team Remote Evaluation Using a Digital Observation Camera

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pioneers Memorial Hospital, Brawley, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study 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

Acronym: STRokE DOC

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 30, 2006
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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