NCT00283868

Brief Summary

The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 19, 2009

Completed
Last Updated

June 3, 2015

Status Verified

September 1, 2009

Enrollment Period

3.6 years

First QC Date

January 26, 2006

Results QC Date

March 27, 2009

Last Update Submit

June 2, 2015

Conditions

Stroke

Keywords

strokedigital videoSPOTRIAS

Outcome Measures

Primary Outcomes (1)

  • Appropriateness of Decision to Treat or Not Treat With Thrombolytics

    This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset. Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was "appropriate" to give or not give rt-PA.

    potentially within 3 hours of symptom onset

Secondary Outcomes (4)

  • Percentage of Participants With Intracerebral Hemorrhage (ICH)

    36 hours

  • Percentage of Total Thrombolytic Administrations

    potentially within 3 hours of symptom onset

  • Time to Treatment Decision for Administration of Thrombolytics

    potentially within 3 hours of symptom onset

  • Percentage of Evaluations With Technical Observations

    Time of consultation

Study Arms (2)

Telemedicine

Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine

Telephone

Patients randomized to this group were evaluated using telephone only and no use of the digital observation camera or DICOM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute Stroke Patients

You may qualify if:

  • years of age or older
  • Symptoms consistent with acute stroke (ischemic or hemorrhagic)
  • Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

You may not qualify if:

  • Unlikely to complete study through 90-day follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pioneers Memorial Hospital

Brawley, California, United States

Location

El Centro Regional Medical Center

El Centro, California, United States

Location

University of California San Diego

San Diego, California, United States

Location

Twin Cities Community Hospital

San Luis Obispo, California, United States

Location

Related Publications (11)

  • 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.

    PMID: 15781827BACKGROUND

  • Crome O, Bahr M. Editorial comment--Remote evaluation of acute ischemic stroke: a reliable tool to extend tissue plasminogen activator use to community and rural stroke patients? Stroke. 2003 Oct;34(10):e191-2. doi: 10.1161/01.STR.0000095163.28915.B9. Epub 2003 Sep 18. No abstract available.

    PMID: 14500919BACKGROUND

  • Patterson V. Teleneurology. J Telemed Telecare. 2005;11(2):55-9. doi: 10.1258/1357633053499840.

    PMID: 15829048BACKGROUND

  • 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.

    PMID: 12624298BACKGROUND

  • Schwamm LH, Rosenthal ES, Hirshberg A, Schaefer PW, Little EA, Kvedar JC, Petkovska I, Koroshetz WJ, Levine SR. Virtual TeleStroke support for the emergency department evaluation of acute stroke. Acad Emerg Med. 2004 Nov;11(11):1193-7. doi: 10.1197/j.aem.2004.08.014.

    PMID: 15528584BACKGROUND

  • 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.

    PMID: 15625294BACKGROUND

  • 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.

    PMID: 14631092BACKGROUND

  • 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.

    PMID: 15166386BACKGROUND

  • Demaerschalk BM, Raman R, Ernstrom K, Meyer BC. Efficacy of telemedicine for stroke: pooled analysis of the Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) and STRokE DOC Arizona telestroke trials. Telemed J E Health. 2012 Apr;18(3):230-7. doi: 10.1089/tmj.2011.0116. Epub 2012 Mar 8.

    PMID: 22400970DERIVED

  • Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6.

    PMID: 18676180DERIVED

  • 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.

    PMID: 18589337DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Brett C. Meyer, MD
Organization
University of California, San Diego
bcmeyer@ucsd.edu
619-543-7760

Study Officials

  • Brett Meyer, MD

    UCSD Stroke Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

January 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 3, 2015

Results First Posted

November 19, 2009

Record last verified: 2009-09

Locations

US(4)