NCT06152016

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
Last Updated

October 3, 2024

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

November 13, 2023

Last Update Submit

October 1, 2024

Conditions

Keywords

BE-FASTFAST

Outcome Measures

Primary Outcomes (1)

  • 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.

    60 minutes

Secondary Outcomes (6)

  • Retention Rate Symptom

    30 days

  • Recall Rate Symptom

    30 days

  • Recall Participant Percentage

    30 days

  • Patrial Recall Participant Percentage

    30 days

  • Common Recall Participant Percentage

    30 days

  • +1 more secondary outcomes

Study Arms (2)

BE-FAST

OTHER
Other: BE-FAST

FAST

OTHER
Other: FAST

Interventions

BE-FASTOTHER

This intervention includes those randomized to the education with the BE-FAST mnemonic.

BE-FAST
FASTOTHER

This intervention includes those randomized to the education with the FAST mnemonic.

FAST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ziad Darkhabani, MD

    Aurora Baycare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 30, 2023

Study Start

November 20, 2021

Primary Completion

May 18, 2023

Study Completion

June 23, 2023

Last Updated

October 3, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations