Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera

NCT00623350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-05-12

No results posted yet for this study

Summary

Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.

Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.

60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)

Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)

Conditions

  • Stroke, Acute

Interventions

OTHER

Telephone

Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.

OTHER

Two way audio/video telemedicine consult

Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.

Sponsors & Collaborators

  • Arizona Department of Health Services

    collaborator OTHER_GOV
  • Yuma Regional Medical Center

    collaborator OTHER
  • Kingman Regional Medical Center

    collaborator OTHER
  • University of California, San Diego

    collaborator OTHER
  • Mayo Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623350 on ClinicalTrials.gov