- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07745582
Improving Parent Sign-Up for a Children's Stroke Awareness Program
Behavioral Insights for Public Health Engagement: A Four-Arm School-Level Comparative Study on Parental Registration in FAST Heroes
Study Overview
Status
Conditions
Detailed Description
FAST Heroes is a school-based education programme that teaches kindergarten-aged children and their families to recognize stroke symptoms (using the FAST acronym: Face, Arms, Speech, Time) and to call emergency services promptly. A key component of the programme requires parents to complete online registration, but registration rates have historically been low. This study was conducted to identify communication strategies that could improve parental registration.
Eligible schools were those that had implemented the FAST Heroes programme during the prior school year (2023-2024) with zero parental registrations recorded. From the pool of eligible schools, participating schools were allocated at the school level to one of four conditions using a pre-specified, non-random balanced allocation procedure intended to achieve comparability across conditions in pupil numbers and school settlement category (urban versus non-urban, per the 2021 Greek Census classification): (1) a printed letter sent home with pupils; (2) an email sent directly to parents; (3) an email combined with weekly teacher-delivered reminders to parents for five weeks; and (4) an email combined with weekly teacher reminders plus an automated chatbot (delivered via a messaging app chatbot) sending parents reminders over the same five-week period.
The primary outcome was the proportion of parents who completed online registration within eight weeks of the initial prompt in their assigned condition. Because schools (not individual pupils) were the unit of allocation while registration was assessed at the level of individual pupils/families, the primary analysis used mixed-effects logistic regression with a random intercept for school to account for clustering within schools. Exploratory analyses examined whether the effect of condition varied by school settlement category (urban vs. non-urban) and by class size.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Thessaloniki, Greece, 54636
- University of Macedonia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- School was implementing the FAST Heroes stroke awareness programme during the 2023-2024 school year
- Zero parental registrations recorded for the school prior to the start of the study (2024-2025 school year)
- School and/or parents provided informed consent to participate
Exclusion criteria:
- Schools with one or more parental registrations already recorded prior to the study period
- Schools that did not provide consent to participate
- Schools not located in Greece
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Printed Letter
Schools in this condition received a printed letter sent home with pupils inviting parents to complete online registration for the FAST Heroes programme.
|
A printed letter sent home with pupils, inviting parents to complete online registration for the FAST Heroes stroke awareness programme.
|
|
Experimental: E-mail
Schools in this condition received an email sent directly to parents inviting them to complete online registration for the FAST Heroes programme.
|
An e-mail sent directly to parents inviting them to complete online registration for the FAST Heroes stroke awareness programme.
|
|
Experimental: E-mail Plus Teacher Feedback
Schools in this condition received an email invitation to register, followed by weekly teacher-delivered reminders to parents for five weeks.
|
An e-mail invitation to register, followed by weekly reminders delivered by teachers to parents over a five-week period.
|
|
Experimental: E-mail Plus Teacher Feedback Plus Chatbot
Schools in this condition received an email invitation to register, weekly teacher-delivered reminders, and an automated chatbot sending weekly reminders to parents over the same five-week period.
|
An e-mail invitation to register, weekly teacher-delivered reminders, and an automated chatbot sending weekly reminders to parents, all over the same five-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Registration Rate
Time Frame: Within 8 weeks of the initial registration prompt
|
Proportion of parents who completed online registration for the FAST Heroes stroke awareness programme, calculated per school condition.
|
Within 8 weeks of the initial registration prompt
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Baskini, PhD, Aristotle University Of Thessaloniki
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/15.06.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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