The Stroke Warning Information and Faster Treatment Study (SWIFT)

Terminated

Phase 2 Results

Trial Description

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.

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.

Trial Stopped: Approval lapse

Conditions

Interventions

  • Interactive Educational Program Behavioral
    Intervention Desc: 2-session interactive stroke educational program
    ARM 1: Kind: Experimental
    Label: 1
    Description: interactive educational program
  • Usual medical care Behavioral
    Intervention Desc: standard educational materials and usual care
    ARM 1: Kind: Experimental
    Label: 2
    Description: usual medical care

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to receive usual medical care (standard educational information on stroke, stroke warning signs and risk factors) or usual medical care plus a 3-session interactive stroke educational program. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. In addition, participants will be contacted every 12 months to check health status and document new stroke events associated with emergency room arrival time.

Outcomes

Type Measure Time Frame Safety Issue
Primary Pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys to 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.
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

Sponsors