Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Brett Meyer, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00390286
First received: October 18, 2006
Last updated: October 1, 2014
Last verified: October 2014

October 18, 2006
October 1, 2014
December 2014
December 2019   (final data collection date for primary outcome measure)
Number of trials participant is enrolled into [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Counting how many patients are enrolled into OTHER clinical trials using a telemedicine technique
Not Provided
Complete list of historical versions of study NCT00390286 on ClinicalTrials.gov Archive Site
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Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC
Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a telemedicine system for performing research in a remote hospital system.

The UCSD Telemedicine system is a digital video camera system, which can transfer video and audio images from a clinic or emergency room to a remote place where a physician can review images in real time (as they happen). The system uses site independent software to access the camera system from multiple locations. This research study will determine if it is feasible to obtain informed consent for various types of research trials (hypothetical, non-invasive, invasive trails) via telemedicine. Inpatient assessments on participants to complete clinical research case report forms by telemedicine will also by performed.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Acute stroke patients

Stroke
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
105
March 2020
December 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male/Female, age 18 years or older
  • Clinical neurological focal deficits consistent with stroke
  • Time of onset 3-24 hours and with stable neurological deficit
  • Signed Informed Consent

Exclusion Criteria:

  • Deficits known to be due to non-stroke etiology
  • Time of onset less than 3 hours
  • Patients unable to give consent
Both
18 Years and older
No
Contact: Brett C Meyer, MD 619-543-6867 bcmeyer@ucsd.edu
United States
 
NCT00390286
051010
No
Brett Meyer, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Brett C. Meyer, MD UCSD Medical Center
University of California, San Diego
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP