The Stroke Warning Information and Faster Treatment Study (SWIFT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1635 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

interactive educational program

Group Type ACTIVE_COMPARATOR

interactive educational program

Intervention Type BEHAVIORAL

2-session interactive stroke educational program

2

usual medical care

Group Type ACTIVE_COMPARATOR

usual medical care

Intervention Type BEHAVIORAL

standard educational materials and usual care

Interventions

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interactive educational program

2-session interactive stroke educational program

Intervention Type BEHAVIORAL

usual medical care

standard educational materials and usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No