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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00283868
First received: January 26, 2006
Last updated: June 2, 2015
Last verified: September 2009
Results First Received: March 27, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Stroke

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment completed in 4/07

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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)

Reporting Groups
  Description
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 only evaluated using telephone and were not evaluated using the digital observation camera or DICOM

Participant Flow:   Overall Study
    Telemedicine   Telephone
STARTED   111   111 
COMPLETED   104   103 
NOT COMPLETED   7   8 
Lost to Follow-up                7                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Total Total of all reporting groups

Baseline Measures
   Telemedicine   Telephone   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   111   222 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   38   36   74 
>=65 years   73   75   148 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.4  (14.5)   69  (14.9)   69.7  (14.7) 
Gender 
[Units: Participants]
     
Female   57   57   114 
Male   54   54   108 
Region of Enrollment 
[Units: Participants]
     
United States   111   111   222 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Appropriateness of Decision to Treat or Not Treat With Thrombolytics   [ Time Frame: potentially within 3 hours of symptom onset ]

2.  Secondary:   Percentage of Participants With Intracerebral Hemorrhage (ICH)   [ Time Frame: 36 hours ]

3.  Secondary:   Percentage of Total Thrombolytic Administrations   [ Time Frame: potentially within 3 hours of symptom onset ]

4.  Secondary:   Time to Treatment Decision for Administration of Thrombolytics   [ Time Frame: potentially within 3 hours of symptom onset ]

5.  Secondary:   Percentage of Evaluations With Technical Observations   [ Time Frame: Time of consultation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Brett C. Meyer, MD
Organization: University of California, San Diego
phone: 619-543-7760
e-mail: bcmeyer@ucsd.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 )
Study First Received: January 26, 2006
Results First Received: March 27, 2009
Last Updated: June 2, 2015