- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06152016
BE FAST vs. FAST: A Study in the General Public. (BFF)
October 1, 2024 updated by: Wake Forest University Health Sciences
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54311
- Aurora BayCare Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: BE-FAST
|
This intervention includes those randomized to the education with the BE-FAST mnemonic.
|
|
Other: FAST
|
This intervention includes those randomized to the education with the FAST mnemonic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention Rate Symptom
Time Frame: 30 days
|
Retention rate of each stroke symptom in the mnemonic
|
30 days
|
|
Recall Rate Symptom
Time Frame: 30 days
|
Total number of stroke symptoms that were accurately recalled by the participants
|
30 days
|
|
Recall Participant Percentage
Time Frame: 30 days
|
Number/percentage of participants able to recall all the symptoms included in the mnemonic
|
30 days
|
|
Patrial Recall Participant Percentage
Time Frame: 30 days
|
Number/percentage of participants able to recall 2 or more symptoms of the FAST mnemonic or 3 or more of the BE-FAST mnemonic.
|
30 days
|
|
Common Recall Participant Percentage
Time Frame: 30 days
|
Number/percentage of participants able to recall the more common symptoms of each mnemonic (Facial weakness, arm weakness and speech difficulties)
|
30 days
|
|
Retention per Professional Background
Time Frame: 30 days
|
Compare participants with medical vs. non-medical professional backgrounds and explore whether there are any group differences in retention rates.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ziad Darkhabani, MD, Aurora Baycare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2021
Primary Completion (Actual)
May 18, 2023
Study Completion (Actual)
June 23, 2023
Study Registration Dates
First Submitted
November 13, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 30, 2023
Study Record Updates
Last Update Posted (Actual)
October 3, 2024
Last Update Submitted That Met QC Criteria
October 1, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-807
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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