Stroke, AcuteNCT06483165
F.A.S.T.-BE FAST Stroke Warning Signs Study
A study testing BE FAST Educational video and F.A.S.T. Educational Video in people with Stroke, Acute, run by American Heart Association at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- BE FAST Educational video and F.A.S.T. Educational Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Stroke, Acute
- Being tested
- BE FAST Educational video, F.A.S.T. Educational Video
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BE FAST Educational videoOther
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.
F.A.S.T. Educational VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BE FAST Group | Experimental | 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. Receives: Other: BE FAST Educational video |
| F.A.S.T. Group | Active comparator | 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. Receives: Other: F.A.S.T. Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start28 Mar 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized parallel 2-group design will be used to allow a rigorous assessment of the comparative efficacy of the two acronyms (BE FAST and F.A.S.T.) among English-speaking adults of diverse race and ethnicity.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Opeolu Adeoye, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483165
- Sponsor's protocol ID
- Pro00077822
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F.A.S.T.-BE FAST Consumer Stroke Warning Signs Study
- ClinicalTrials.gov ID
- NCT06483165
- Acronym / sponsor ID
- Pro00077822
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized parallel 2-group design will be used to allow a rigorous assessment of the comparative efficacy of the two acronyms (BE FAST and F.A.S.T.) among English-speaking adults of diverse race and ethnicity.
| Arm | Type | Receives |
|---|---|---|
| BE FAST Group | Experimental | Other: BE FAST Educational videoThe 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. |
| F.A.S.T. Group | Active comparator | Other: F.A.S.T. Educational VideoThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BE FAST Educational videoA 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. | Other | BE FAST Group |
| F.A.S.T. Educational VideoA 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. | Other | F.A.S.T. Group |
Primary outcome
Intent to Call 911 30-Days Post Education
Time frame: 30 days
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.
1 secondary outcome
Warning Signs Net Positive Accuracy Score 30-Days Post Education
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Opeolu Adeoye, MD study chair
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BE FAST Educational video and F.A.S.T. Educational Video in people with Stroke, Acute, run by American Heart Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intent to Call 911 30-Days Post Education (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.