NCT00415389

Brief Summary

The purposes of this study are to determine the effectiveness of an interactive stroke educational program compared to standard educational materials and usual care, to increase stroke knowledge, and to improve emergency room arrival times upon onset of stroke symptoms.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,635

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

7.7 years

First QC Date

December 21, 2006

Last Update Submit

February 15, 2013

Conditions

Stroke

Keywords

Strokeinteractive educational programacute ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Surveillance methodologies will measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one month and one year post stroke event.

    at one month and one year post stroke event

Study Arms (2)

1

ACTIVE COMPARATOR

interactive educational program

Behavioral: interactive educational program

2

ACTIVE COMPARATOR

usual medical care

Behavioral: usual medical care

Interventions

interactive educational programBEHAVIORAL

2-session interactive stroke educational program

1
usual medical careBEHAVIORAL

standard educational materials and usual care

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with cerebral infarction/TIA hospitalized at New York Presbyterian Hospital (Milstein Hospital and Allen Pavilion)
  • year-old and older at onset of the stroke
  • Self-identified as of White, Black or Hispanic race-ethnicity
  • Living in a household with a telephone

You may not qualify if:

  • Patients unable to give informed consent
  • Discharged to nursing home or requiring 24 hour care.
  • A Modified Rankin score \> 4 at baseline
  • Severe aphasia or severe cognitive impairment limiting comprehension
  • Pre-stroke dementia history
  • Patients with end stage cancer, or other medical conditions resulting in mortality \</= 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurological Institute, 710 W 168th Street, 6th Floor, Room 640

New York, New York, 10032, United States

Location

Related Publications (3)

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

    PMID: 34813082DERIVED

  • Boden-Albala B, Stillman J, Roberts ET, Quarles LW, Glymour MM, Chong J, Moats H, Torrico V, Parides MC. Comparison of Acute Stroke Preparedness Strategies to Decrease Emergency Department Arrival Time in a Multiethnic Cohort: The Stroke Warning Information and Faster Treatment Study. Stroke. 2015 Jul;46(7):1806-12. doi: 10.1161/STROKEAHA.114.008502. Epub 2015 Jun 11.

    PMID: 26069259DERIVED

  • Kerns JM, Heidmann D, Petty M, Prabhakaran S. Optimizing public health strategies for stroke education: need for a controlled trial. Am J Ther. 2011 Jan;18(1):81-90. doi: 10.1097/MJT.0b013e3181e123cd.

    PMID: 20634684DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bernadette Boden-Albala, DrPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

February 1, 2005

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)