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

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ClinicalTrials.gov Identifier: NCT00390286
Recruitment Status : Withdrawn (no funding)
First Posted : October 19, 2006
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Phase
Stroke Phase 1

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.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: October 19, 2006    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

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