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
  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 University of California, San Diego:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 105
Study Start Date: December 2014
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390286

Contacts
Contact: Brett C Meyer, MD 619-543-6867 bcmeyer@ucsd.edu

Locations
United States, California
UCSD Stroke Center Not yet recruiting
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:
Additional 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
Study First Received: October 18, 2006
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Telemedicine

ClinicalTrials.gov processed this record on October 19, 2014