The Stroke Warning Information and Faster Treatment Study (SWIFT)

This study has been terminated.
(Approval lapse)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00415389
First received: December 21, 2006
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: interactive educational program
Behavioral: usual medical care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Stroke Warning Information and Faster Treatment Study (SWIFT)

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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. [ Time Frame: at one month and one year post stroke event ] [ Designated as safety issue: No ]

Enrollment: 1635
Study Start Date: February 2005
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
interactive educational program
Behavioral: interactive educational program
2-session interactive stroke educational program
Active Comparator: 2
usual medical care
Behavioral: usual medical care
standard educational materials and usual care

Detailed Description:

Rapid diagnosis and treatment of acute ischemic stroke is critical to reduce disability and death caused by stroke. While recombinant tissue plasminogen activator, or rt-PA, is the only approved treatment for acute ischemic stroke, less than 2-3 percent of individuals with stroke actually receive treatment. The inability to capture acute ischemic stroke cases within 3 hours of symptom onset is one critical factor. Populations at highest risk for stroke are significantly undereducated about the need for rapid, intervention upon onset of stroke symptoms. This is especially true among vulnerable populations including African Americans, Hispanics, and the poor.

The purpose of this study is to evaluate the effectiveness of a 2-session, culturally-sensitive, interactive stroke educational program compared to standard educational materials and usual care. In this study, the scientists will determine if the interactive program increases knowledge about stroke, and results in earlier arrival to the emergency room in the case of stroke.

The study will enroll 1400 individuals who have had a stroke or transient ischemic attack (TIA). Participants will be randomized to receive usual medical care——which includes standard educational information on stroke, stroke warning signs and risk factors——or usual medical care plus a 2-session interactive stroke educational program. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. In additional, participants will be contacted every 12 months to check health status and document new stroke events associated with emergency room arrival time.

The SWIFT study is part of the Specialized Program for Translational Research in Acute Stroke (SPOTRIAS), which seeks to understand why certain people may be at increased risk for stroke. The goal of the study is to increase stroke knowledge, change behavior, and improve emergency room arrival times upon onset of stroke symptoms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with cerebral infarction/TIA hospitalized at New York Presbyterian Hospital (Milstein Hospital and Allen Pavilion)
  • 18 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415389

Locations
United States, New York
Neurological Institute, 710 W 168th Street, 6th Floor, Room 640
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Bernadette Boden-Albala, DrPH Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00415389     History of Changes
Other Study ID Numbers: AAAA9948, P50NS049060
Study First Received: December 21, 2006
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Stroke
interactive educational program
acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014