The Stroke Warning Information and Faster Treatment Study (SWIFT)

Stroke Clinical Trial

Official title:

The Stroke Warning Information and Faster Treatment Study (SWIFT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00415389
• Other study ID #: AAAA9948
• Secondary ID: P50NS049060
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2006
• Last updated: February 15, 2013
• Start date: February 2005
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1635
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• interactive educational program
2-session interactive stroke educational program
• usual medical care
standard educational materials and usual care

Locations

Country	Name	City	State
United States	Neurological Institute, 710 W 168th Street, 6th Floor, Room 640	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No