NCT07773545

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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

4 years

First QC Date

August 12, 2026

Last Update Submit

August 15, 2026

Conditions

Keywords

Helmet useEmergency Departmentbehavioral changeeducational interventionvideo intervention

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

EXPERIMENTAL

Participants assigned to the intervention group will receive standard emergency care in addition to a short online educational video promoting helmet use.

Behavioral: Educational video

Control Group

NO INTERVENTION

Participants 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.

Educational video

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Haaglanden Medical Center

The Hague, Netherlands

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Following informed consent and completion of a brief baseline questionnaire, participants will be randomly allocated to either the intervention group or the control group. Participants assigned to the intervention group will receive standard emergency care in addition to a short online educational video promoting helmet use. 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. Participants in the control group will receive standard emergency care alone without the educational video.
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.

Locations