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| ID | Type | Description | Link |
|---|---|---|---|
| P50NS044148 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | potentially within 3 hours of symptom onset |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Acute Stroke Patients
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| Name | Affiliation | Role |
|---|---|---|
| Brett Meyer, MD | UCSD Stroke Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pioneers Memorial Hospital | Brawley | California | United States | |||
| El Centro Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15781827 | Background | Meyer BC, Lyden PD, Al-Khoury L, Cheng Y, Raman R, Fellman R, Beer J, Rao R, Zivin JA. Prospective reliability of the STRokE DOC wireless/site independent telemedicine system. Neurology. 2005 Mar 22;64(6):1058-60. doi: 10.1212/01.WNL.0000154601.26653.E7. | |
| 14500919 | Background | Crome O, Bahr M. Editorial comment--Remote evaluation of acute ischemic stroke: a reliable tool to extend tissue plasminogen activator use to community and rural stroke patients? Stroke. 2003 Oct;34(10):e191-2. doi: 10.1161/01.STR.0000095163.28915.B9. Epub 2003 Sep 18. No abstract available. |
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There were 11 initial "run-in" patients used to validate the system but these patients were excluded from the final analysis. There was also 1 patient removed from analysis because of a protocol violation (age < 18) so this patient was excluded rom any analysis (Initial patients=234. 11 Run in=223. 1 removed=222. This accounts for final numbers)
Recruitment completed in 4/07
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine | Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine |
| FG001 | Telephone | Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine | Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine |
| BG001 | Telephone | Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone. | Posted | Number | percentage of participants | potentially within 3 hours of symptom onset |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett C. Meyer, MD | University of California, San Diego | 619-543-7760 | bcmeyer@ucsd.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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. | 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 of consultation |
| 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 |
| 15829048 | Background | Patterson V. Teleneurology. J Telemed Telecare. 2005;11(2):55-9. doi: 10.1258/1357633053499840. |
| 12624298 | Background | LaMonte MP, Bahouth MN, Hu P, Pathan MY, Yarbrough KL, Gunawardane R, Crarey P, Page W. Telemedicine for acute stroke: triumphs and pitfalls. Stroke. 2003 Mar;34(3):725-8. doi: 10.1161/01.STR.0000056945.36583.37. Epub 2003 Jan 30. |
| 15528584 | Background | Schwamm LH, Rosenthal ES, Hirshberg A, Schaefer PW, Little EA, Kvedar JC, Petkovska I, Koroshetz WJ, Levine SR. Virtual TeleStroke support for the emergency department evaluation of acute stroke. Acad Emerg Med. 2004 Nov;11(11):1193-7. doi: 10.1197/j.aem.2004.08.014. |
| 15625294 | Background | Audebert HJ, Kukla C, Clarmann von Claranau S, Kuhn J, Vatankhah B, Schenkel J, Ickenstein GW, Haberl RL, Horn M; TEMPiS Group. Telemedicine for safe and extended use of thrombolysis in stroke: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria. Stroke. 2005 Feb;36(2):287-91. doi: 10.1161/01.STR.0000153015.57892.66. Epub 2004 Dec 29. |
| 14631092 | Background | Wiborg A, Widder B; Telemedicine in Stroke in Swabia Project. Teleneurology to improve stroke care in rural areas: The Telemedicine in Stroke in Swabia (TESS) Project. Stroke. 2003 Dec;34(12):2951-6. doi: 10.1161/01.STR.0000099125.30731.97. Epub 2003 Nov 20. |
| 15166386 | Background | Wang S, Gross H, Lee SB, Pardue C, Waller J, Nichols FT 3rd, Adams RJ, Hess DC. Remote evaluation of acute ischemic stroke in rural community hospitals in Georgia. Stroke. 2004 Jul;35(7):1763-8. doi: 10.1161/01.STR.0000131858.63829.6e. Epub 2004 May 27. |
| 22400970 | Derived | Demaerschalk BM, Raman R, Ernstrom K, Meyer BC. Efficacy of telemedicine for stroke: pooled analysis of the Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) and STRokE DOC Arizona telestroke trials. Telemed J E Health. 2012 Apr;18(3):230-7. doi: 10.1089/tmj.2011.0116. Epub 2012 Mar 8. |
| 18676180 | Derived | Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6. |
| 18589337 | Derived | Meyer BC, Raman R, Chacon MR, Jensen M, Werner JD. Reliability of site-independent telemedicine when assessed by telemedicine-naive stroke practitioners. J Stroke Cerebrovasc Dis. 2008 Jul-Aug;17(4):181-6. doi: 10.1016/j.jstrokecerebrovasdis.2008.01.008. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 |
| Telemedicine |
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine |
| OG001 | Telephone | Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM |
|
|
| Secondary | 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. | Posted | Number | Percentage of participants | 36 hours |
|
|
|
| Secondary | 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. | Posted | Number | Percentage of participants | potentially within 3 hours of symptom onset |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Minutes | potentially within 3 hours of symptom onset |
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|
|
| Secondary | 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. | Posted | Number | Percentage of Evaluations | Time of consultation |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |