StrokeBFFNCT06152016
BE FAST vs. FAST: A Study in the General Public.
A study testing BE-FAST and FAST in people with Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- BE-FAST and FAST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 23 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject 18 years of age or older
- Subject speaks English (Does not need interpreter)
- Subject able to read English
- Subject willing to provide a phone number for future follow up
- Subject willing and agreeable to up to 2 phone follow up calls
- Subject willing to provide verbal consent to participate
Who cannot join
- Subject non-English speaking (needs interpreter)
- Subject has visual or hearing impairment
- Subject has history of Dementia or a learning disability
- Subject had stroke education within the past year
- Subject had a previous stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
About this study
Official title: BE FAST vs. FAST: A Randomized Trial Comparing Retention of Stroke Symptoms Between Two Mnemonics in the General Public.
A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals.
- Conditions
- Stroke
- Being tested
- BE-FAST, FAST
- Keywords
- BE-FAST, FAST
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BE-FASTOther
This intervention includes those randomized to the education with the BE-FAST mnemonic.
FASTOther
This intervention includes those randomized to the education with the FAST mnemonic.
| Study group | Role | What they receive |
|---|---|---|
| BE-FAST | Other | Not described Receives: Other: BE-FAST |
| FAST | Other | Not described Receives: Other: FAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall Visit 1
Number/percentage of participants in the FAST and BE-FAST groups at Visit 1 who accurately recall the mnemonic they were taught during the education session.
Measured: 60 minutes
Secondary outcomes (6)
Retention Rate Symptom
Retention rate of each stroke symptom in the mnemonic
Measured: 30 days
Recall Rate Symptom
Total number of stroke symptoms that were accurately recalled by the participants
Measured: 30 days
Recall Participant Percentage
Number/percentage of participants able to recall all the symptoms included in the mnemonic
Measured: 30 days
Patrial Recall Participant Percentage
Number/percentage of participants able to recall 2 or more symptoms of the FAST mnemonic or 3 or more of the BE-FAST mnemonic.
Measured: 30 days
Common Recall Participant Percentage
Number/percentage of participants able to recall the more common symptoms of each mnemonic (Facial weakness, arm weakness and speech difficulties)
Measured: 30 days
Retention per Professional Background
Compare participants with medical vs. non-medical professional backgrounds and explore whether there are any group differences in retention rates.
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 posted30 Nov 2023
- Study start20 Nov 2021
- Primary completion18 May 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- BayCare Health System, Aurora BayCare Medical Center
- Responsible party
- Sponsor
- Investigators
- Ziad Darkhabani, MD, Principal investigator, Aurora Baycare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152016
- Sponsor's protocol ID
- 19-807
- Acronym
- BFF
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darkhabani MZ, Homa-Bonell JK, Thoreson L, Bobholz JA, Spaulding D, Engebose M. BE FAST Versus FAST: A Randomized Pilot Trial Comparing Retention of Stroke Symptoms Between 2 Mnemonics. J Am Heart Assoc. 2024 Oct;13(19):e035696. doi: 10.1161/JAHA.123.035696. Epub 2024 Sep 18.
PubMed 39291473
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE FAST vs. FAST: A Randomized Trial Comparing Retention of Stroke Symptoms Between Two Mnemonics in the General Public.
- ClinicalTrials.gov ID
- NCT06152016
- Acronym / sponsor ID
- BFF / 19-807
- Conditions
- Stroke
- Keywords
- BE-FAST, FAST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- BayCare Health System, Aurora BayCare Medical Center
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 30 Nov 2023 (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.
A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BE-FAST | Other | Other: BE-FAST |
| FAST | Other | Other: FAST |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject 18 years of age or older
- Subject speaks English (Does not need interpreter)
- Subject able to read English
- Subject willing to provide a phone number for future follow up
- Subject willing and agreeable to up to 2 phone follow up calls
Key exclusion criteria (5 listed)
- Subject non-English speaking (needs interpreter)
- Subject has visual or hearing impairment
- Subject has history of Dementia or a learning disability
- Subject had stroke education within the past year
- Subject had a previous stroke
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-FASTThis intervention includes those randomized to the education with the BE-FAST mnemonic. | Other | BE-FAST |
| FASTThis intervention includes those randomized to the education with the FAST mnemonic. | Other | FAST |
Primary outcome
Recall Visit 1
Time frame: 60 minutes
Number/percentage of participants in the FAST and BE-FAST groups at Visit 1 who accurately recall the mnemonic they were taught during the education session.
6 secondary outcomes
Retention Rate Symptom
Time frame: 30 days
Recall Rate Symptom
Time frame: 30 days
Recall Participant Percentage
Time frame: 30 days
Patrial Recall Participant Percentage
Time frame: 30 days
Common Recall Participant Percentage
Time frame: 30 days
Retention per Professional Background
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 39291473Darkhabani MZ, Homa-Bonell JK, Thoreson L, Bobholz JA, Spaulding D, Engebose M. BE FAST Versus FAST: A Randomized Pilot Trial Comparing Retention of Stroke Symptoms Between 2 Mnemonics. J Am Heart Assoc. 2024 Oct;13(19):e035696. doi: 10.1161/JAHA.123.035696. Epub 2024 Sep 18.
- 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.
Ziad Darkhabani, MD principal investigator
Aurora Baycare
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 and FAST in people with Stroke, run by Wake Forest University Health Sciences 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recall Visit 1 (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152016, which also lists 1 linked publication.
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 Oct 2024.