NCT01226862

Brief Summary

This study will promote the development and economic sustainability of telemedicine for acute stroke treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

2.4 years

First QC Date

October 20, 2010

Last Update Submit

December 4, 2013

Conditions

Keywords

StrokeTelemedicineTelestroke

Outcome Measures

Primary Outcomes (1)

  • IV tPA administration

    Correctness of decisions regarding IV tPA administration in acute stroke

    Day 7/Discharge

Secondary Outcomes (1)

  • Multiple Study Assessments

    Day 7 and/or Day 30 and/or Day 90 and/or at discharge

Study Arms (3)

Hub Hospital

Hub Hospital Cohort: Joint Commission-certified Primary Stroke Centers where patients are treated using hospital-based stroke teams and pathways; these hospital personnel also provide telemedicine consultation to satellite hospitals.

Spoke Hospital

Spoke Hospital Cohort: non-stroke center certified sites, where patients are treated at an in-network telestroke community hospital using telemedicine technology with consultation provided by physicians from a hub hospital.

Control Hospital

Control Hospital Cohort: non-stroke center certified sites with no telemedicine services.

Eligibility Criteria

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

600 subjects meeting inclusion and exclusion criteria will be enrolled consecutively over approximately 12 months and followed for 90 days post-stroke.

You may qualify if:

  • Age greater than or equal to 18 years old
  • Acute ischemic stroke within 12 hours of stroke onset

You may not qualify if:

  • Life expectancy less than 90 days
  • Patient unwilling to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gene Sung, MD, MPH

    University of Southern California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations