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AzTrials

StrokeNCT00390286

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

An observational study of Stroke, run by University of California, San Diego at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2016to Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute stroke patients

Who may be able to join

  • 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

Who cannot join

  • Deficits known to be due to non-stroke etiology
  • Time of onset less than 3 hours
  • Patients unable to give consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSD Stroke Center

    San Diego, California, 92103-8466

Other trials in United States

About this study

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.

Read the 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.

Conditions
Stroke
Keywords
Telemedicine
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of trials participant is enrolled into

    Counting how many patients are enrolled into OTHER clinical trials using a telemedicine technique

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionMar 2020 (estimated)

Why it stopped: no funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390286
Sponsor's protocol ID
051010
Status last verified
Oct 2016
First submitted
18 Oct 2006
Last updated
26 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Meyer BC, Lyden PD, Al-Khoury L, Cheng Y, Raman R, Fellman R, Beer J, Rao R, Zivin JA. Prospective reliability of the STRokE DOC wireless/site independent telemedicine system. Neurology. 2005 Mar 22;64(6):1058-60. doi: 10.1212/01.WNL.0000154601.26653.E7.

    PubMed 15781827

  • LaMonte MP, Bahouth MN, Hu P, Pathan MY, Yarbrough KL, Gunawardane R, Crarey P, Page W. Telemedicine for acute stroke: triumphs and pitfalls. Stroke. 2003 Mar;34(3):725-8. doi: 10.1161/01.STR.0000056945.36583.37. Epub 2003 Jan 30.

    PubMed 12624298

  • Levine SR, Gorman M. "Telestroke" : the application of telemedicine for stroke. Stroke. 1999 Feb;30(2):464-9. doi: 10.1161/01.str.30.2.464.

    PubMed 9933289

  • Audebert HJ, Kukla C, Clarmann von Claranau S, Kuhn J, Vatankhah B, Schenkel J, Ickenstein GW, Haberl RL, Horn M; TEMPiS Group. Telemedicine for safe and extended use of thrombolysis in stroke: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria. Stroke. 2005 Feb;36(2):287-91. doi: 10.1161/01.STR.0000153015.57892.66. Epub 2004 Dec 29.

    PubMed 15625294

  • Wiborg A, Widder B; Telemedicine in Stroke in Swabia Project. Teleneurology to improve stroke care in rural areas: The Telemedicine in Stroke in Swabia (TESS) Project. Stroke. 2003 Dec;34(12):2951-6. doi: 10.1161/01.STR.0000099125.30731.97. Epub 2003 Nov 20.

    PubMed 14631092

  • Wang S, Gross H, Lee SB, Pardue C, Waller J, Nichols FT 3rd, Adams RJ, Hess DC. Remote evaluation of acute ischemic stroke in rural community hospitals in Georgia. Stroke. 2004 Jul;35(7):1763-8. doi: 10.1161/01.STR.0000131858.63829.6e. Epub 2004 May 27.

    PubMed 15166386

  • Meyer BC, Raman R, Chacon MR, Jensen M, Werner JD. Reliability of site-independent telemedicine when assessed by telemedicine-naive stroke practitioners. J Stroke Cerebrovasc Dis. 2008 Jul-Aug;17(4):181-6. doi: 10.1016/j.jstrokecerebrovasdis.2008.01.008.

    PubMed 18589337

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of trials participant is enrolled into (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00390286, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.

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