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

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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Stroke
Enrollment 234
Recruitment Details Recruitment completed in 4/07
Pre-assignment Details 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)
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Period Title: Overall Study
Started 111 111
Completed 104 103
Not Completed 7 8
Reason Not Completed
Lost to Follow-up             7             8
Arm/Group Title Telemedicine Telephone Total
Hide Arm/Group Description Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM Total of all reporting groups
Overall Number of Baseline Participants 111 111 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 222 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
38
  34.2%
36
  32.4%
74.0
>=65 years
73
  65.8%
75
  67.6%
148.0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 111 participants 222 participants
70.4  (14.5) 69  (14.9) 69.7  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 222 participants
Female
57
  51.4%
57
  51.4%
114.0
Male
54
  48.6%
54
  48.6%
108.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 111 participants 222 participants
111 111 222
1.Primary Outcome
Title Appropriateness of Decision to Treat or Not Treat With Thrombolytics
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Number of Participants Analyzed 104 103
Measure Type: Number
Unit of Measure: percentage of participants
98 82
2.Secondary Outcome
Title Percentage of Participants With Intracerebral Hemorrhage (ICH)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Number of Participants Analyzed 104 103
Measure Type: Number
Unit of Measure: Percentage of participants
7 8
3.Secondary Outcome
Title Percentage of Total Thrombolytic Administrations
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Number of Participants Analyzed 104 103
Measure Type: Number
Unit of Measure: Percentage of participants
28 23
4.Secondary Outcome
Title Time to Treatment Decision for Administration of Thrombolytics
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Number of Participants Analyzed 104 103
Mean (Standard Deviation)
Unit of Measure: Minutes
32  (17) 23  (24)
5.Secondary Outcome
Title Percentage of Evaluations With Technical Observations
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telemedicine Telephone
Hide Arm/Group Description:
Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Number of Participants Analyzed 104 103
Measure Type: Number
Unit of Measure: Percentage of Evaluations
0 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brett C. Meyer, MD
Organization: University of California, San Diego
Phone: 619-543-7760
EMail: bcmeyer@ucsd.edu
Publications:
Layout table for additonal information
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
P50NS044148 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: March 27, 2009
Results First Posted: November 19, 2009
Last Update Posted: June 3, 2015