F.A.S.T.-BE FAST Stroke Warning Signs Study

F.A.S.T.-BE FAST Consumer Stroke Warning Signs Study

The goal of this randomized controlled trial is to learn whether the BE FAST (Balance, Eyes, Face, Arm, Speech, and Time) acronym works at least as well or better than the F.A.S.T. (Face drooping, Arm weakness, Speech difficulty, Time to call 911) acronym in helping participants learn and remember the warning signs of a stroke. The main questions it aims to answer are:

• Does the BE FAST acronym increase understanding among participants that calling 911 is the right first step they should take if a stroke is suspected?
• Does the BE FAST acronym perform as well as or better than the F.A.S.T. acronym in helping participants remember stroke warning signs on a letter-aided open-ended basis? Researchers will compare the BE FAST acronym to the F.A.S.T. acronym to see if the BE FAST acronym works at least as well as the F.A.S.T. acronym in teaching participants about the warning signs of a stroke and the importance of calling 911 if they suspect a stroke.

Participants will:

• Take a survey about their knowledge of stroke and its symptoms
• Watch a short video about one of the acronyms and then answer more questions about what they learned
• Take another survey after 30 days about the acronym they learned about

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: BE FAST Educational video; Other: F.A.S.T. Educational Video

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • American Heart Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able and willing to provide written informed consent;
• Have access to a computer, tablet or mobile device with internet services;
• Proficient in reading and writing the English language; and
• Reside outside a medical facility.

Exclusion Criteria:

• Not able to provide written informed consent;
• Do not have access to a computer, tablet or mobile device with internet;
• Not proficient in reading and writing in English language; or
• Reside in a medical facility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BE FAST Group; The experimental BE FAST acronym education messaging, including 5 stroke warning signs and a call-to-action to call 911, will be shown to the participants using a brief video.	Other: BE FAST Educational video; A 1-minute educational video format using BE FAST. Each acronym will be visually displayed in the video and audio voice over of each letter and corresponding phrase will be audible in English. The look, feel, and messaging in each video will be the same except for the acronyms.
Active Comparator: F.A.S.T. Group; The comparator F.A.S.T. acronym education messaging, including 3 stroke warning signs and a call-to-action to call 911, will be shown to the participants using a brief video.	Other: F.A.S.T. Educational Video; A 1-minute educational video format using F.A.S.T. Each acronym will be visually displayed in the video and audio voice over of each letter and corresponding phrase will be audible in English. The look, feel, and messaging in each video will be the same except for the acronyms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intent to Call 911 30-Days Post Education	The identification of calling 9-1-1 as the accurate immediate action to stroke being suspected at 30-days post-educational intervention. Outcome is not being reported on a scale. We are using dichotomous coding of correct or incorrect response, with the response of "Call 9-1-1" being the correct response from the pick list.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Warning Signs Net Positive Accuracy Score 30-Days Post Education	Net positive accuracy score on the common letters (symptoms) in both acronyms on a letter-aided open-ended basis at 30-days post-educational intervention. Outcome is not being reported on a scale. We are using dichotomous coding for the letters in each acronym, where 0 = completely incorrect and 1 = fully correct (i.e. higher scores mean a better outcome).	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intent to Call 911 Immediately Post-Education	The identification of calling 9-1-1 as the accurate immediate action to stroke being suspected immediately following the educational intervention. Outcome is not being reported on a scale. We are using dichotomous coding of correct or incorrect response, with the response of "Call 9-1-1" being the correct response from the pick list.	Immediately after intervention
Change in Warning Signs Net Positive Accuracy Score Immediately Post-Education	Net positive accuracy score on the common letters (symptoms) in both acronyms on a letter-aided open-ended basis immediately following the educational intervention. Outcome is not being reported on a scale. We are using dichotomous coding for the letters in each acronym, where 0 = completely incorrect and 1 = fully correct (i.e. higher scores mean a better outcome).	Immediately after intervention

Collaborators and Investigators

• Sponsor: American Heart Association
• Investigators: Study Chair: Opeolu Adeoye, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Pro00077822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No