An observational study in Stroke, sponsored by University of California, San Diego. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-03.
Sponsored by University of California, San Diego · Observational
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 234 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acute Stroke Patients
Exclusion Criteria:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were evaluated using telephone only and no use of the digital observation camera or DICOM
Appropriateness of Decision to Treat or Not Treat With Thrombolytics
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.
Time frame: potentially within 3 hours of symptom onset
Percentage of Participants With Intracerebral Hemorrhage (ICH)
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.
Time frame: 36 hours
Percentage of Total Thrombolytic Administrations
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 frame: potentially within 3 hours of symptom onset
Time to Treatment Decision for Administration of Thrombolytics
time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.
Time frame: potentially within 3 hours of symptom onset
Percentage of Evaluations With Technical Observations
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.
Time frame: Time of consultation
Recruitment completed in 4/07
| Milestone | Telemedicine | Telephone |
|---|---|---|
| Started | 111 | 111 |
| Completed | 104 | 103 |
| Not completed | 7 | 8 |
| Withdrew: Lost to follow-up | 7 | 8 |
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.
| percentage of participants | Telemedicine | Telephone |
|---|---|---|
| Appropriateness of Decision to Treat or Not Treat With Thrombolytics | 98 | 82 |
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 participants | Telemedicine | Telephone |
|---|---|---|
| Percentage of Participants With Intracerebral Hemorrhage (ICH) | 7 | 8 |
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.
| Percentage of participants | Telemedicine | Telephone |
|---|---|---|
| Percentage of Total Thrombolytic Administrations | 28 | 23 |
time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.
| Minutes | Telemedicine | Telephone |
|---|---|---|
| Time to Treatment Decision for Administration of Thrombolytics | 32 ± 17 | 23 ± 24 |
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.
| Percentage of Evaluations | Telemedicine | Telephone |
|---|---|---|
| Percentage of Evaluations With Technical Observations | 0 | 12 |
| Age, Categorical(Participants) | Telemedicine | Telephone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0.0 |
| Between 18 and 65 years | 38 | 36 | 74.0 |
| >=65 years | 73 | 75 | 148.0 |
| Age, Continuous(years) | Telemedicine | Telephone | Total |
|---|---|---|---|
| Mean | 70.4 ± 14.5 | 69 ± 14.9 | 69.7 ± 14.7 |
| Sex: Female, Male(Participants) | Telemedicine | Telephone | Total |
|---|---|---|---|
| Female | 57 | 57 | 114.0 |
| Male | 54 | 54 | 108.0 |
| Region of Enrollment(participants) | Telemedicine | Telephone | Total |
|---|---|---|---|
| United States | 111 | 111 | 222.0 |
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Diego