The Effect of Visual Patient Education on Helmet Use Behaviour in Elderly Patients After a Bicycle, E-bike, or Moped Accident
HelmED RCT
1 other identifier
interventional
228
1 country
3
Brief Summary
This is a multicenter randomized controlled trial (RCT) targeting individuals aged 60 and older who present to the emergency department following an accident. The study examines the effect of watching an educational video on helmet use specifically, whether it leads to increased helmet usage in the future. Individuals aged 60 or older who were not wearing a helmet while riding a bicycle, e-bike, or (e)-moped at the time of the accident are eligible for inclusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
3 active sites
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
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 12, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
CompletedAugust 19, 2026
August 1, 2026
4 years
August 12, 2026
August 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Helmet use
Self-reported helmet use (single-item survey question, yes/no), assessed 6 months after ED visit.
6 months
Secondary Outcomes (1)
Patient attitude towards helmet use
6 months
Study Arms (2)
Educational video
EXPERIMENTALParticipants assigned to the intervention group will receive standard emergency care in addition to a short online educational video promoting helmet use.
Control Group
NO INTERVENTIONParticipants in the control group will receive standard emergency care alone without the educational video.
Interventions
The video is designed to provide evidence-based information regarding the burden of bicycle- and scooter-related head injuries, the protective effects of helmet use, and the potential health benefits of wearing a helmet during future rides.
Eligibility Criteria
You may qualify if:
- Age ≥60 years
- Attending the ED after a (electric) bicycle or scooter traffic accident
- Signed informed consent by patient
- Maximum points (15) on Glasgow Coma Scale
You may not qualify if:
- Linguistic barrier
- Illiteracy or blindness
- Helmet use during the accident
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Leiden University Medical Center
Leiden, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
August 12, 2026
First Posted
August 19, 2026
Study Start
September 1, 2022
Primary Completion
September 1, 2026
Study Completion
September 1, 2026
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
Data will be entered and managed via Castor. Investigators will be able to review pseudo-anonymized data after 2-step-verification log-in.