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

December 21, 2006
February 15, 2013
February 2005
October 2012   (final data collection date for primary outcome measure)
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 ]
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 year post event.
Complete list of historical versions of study NCT00415389 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Stroke Warning Information and Faster Treatment Study (SWIFT)
The Stroke Warning Information and Faster Treatment Study (SWIFT)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Stroke
  • Behavioral: interactive educational program
    2-session interactive stroke educational program
  • Behavioral: usual medical care
    standard educational materials and usual care
  • Active Comparator: 1
    interactive educational program
    Intervention: Behavioral: interactive educational program
  • Active Comparator: 2
    usual medical care
    Intervention: Behavioral: usual medical care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1635
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00415389
AAAA9948, P50NS049060
No
Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Bernadette Boden-Albala, DrPH Columbia University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP