An interventional study of Educational video in Helmet Use, Cyclists and Video Information, sponsored by Erasmus Medical Center. Active, not recruiting at 3 sites in Netherlands. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention
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.
The present study is a multicenter randomized controlled trial designed to evaluate whether a brief online educational intervention delivered after an ED visit can increase helmet use among older adults. Eligible participants are patients aged 60 years or older who were not wearing a helmet at the time of their bicycle, e-bike, or moped accident and who present to one of the participating emergency departments.
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 moped-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.
The primary objective is to determine whether exposure to the educational video results in a higher proportion of helmet users six months after the index ED visit compared with standard care alone. Helmet use at six months will be assessed through a structured telephone interview.
Secondary objectives include evaluating the association between helmet use at six months and symptoms of anxiety and depression, as measured using the Hospital Anxiety and Depression Scale (HADS). In addition, demographic characteristics, accident characteristics (including accident location and weather conditions), injury characteristics (including injury type, anatomical injury location, and presence of multiple injuries), and patient characteristics (including age, educational level, and intoxication status) will be collected to describe the study population and explore factors associated with subsequent helmet use.
Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive standard emergency care alone without the educational video.
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.
Helmet use
Self-reported helmet use (single-item survey question, yes/no), assessed 6 months after ED visit.
Time frame: 6 months
Patient attitude towards helmet use
Patients' attitude towards helmet use was assessed across three questions, using a study-specific questionnaire administered at follow-up: (1) Has your opinion regarding bicycle helmet use changed following your accident? (More positive/more negative/no changes) 2) Would you advise other cyclists to wear a bicycle helmet? (yes/no) 3) If bicycle helmet use was made mandatory, would you consider this an appropriate public health- and safety measure? (yes/no)
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be entered and managed via Castor. Investigators will be able to review pseudo-anonymized data after 2-step-verification log-in.
Started Sep 2022 (actual). Primary completion is estimated for Sep 2026, 48 months after the start.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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