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

This study has been withdrawn prior to enrollment.
(no funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390286
First Posted: October 19, 2006
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brett Meyer, University of California, San Diego
  Purpose
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.

Condition Phase
Stroke Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

Further study details as provided by Brett Meyer, University of California, San Diego:

Primary Outcome Measures:
  • Number of trials participant is enrolled into [ Time Frame: 5 years ]
    Counting how many patients are enrolled into OTHER clinical trials using a telemedicine technique


Enrollment: 0
Study Start Date: November 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute stroke patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390286


Locations
United States, California
UCSD Stroke Center
San Diego, California, United States, 92103-8466
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brett C. Meyer, MD UCSD Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brett Meyer, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00390286     History of Changes
Other Study ID Numbers: 051010
First Submitted: October 18, 2006
First Posted: October 19, 2006
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Brett Meyer, University of California, San Diego:
Telemedicine