Helmet UseHelmED RCTNCT07773545
The Effect of Visual Patient Education on Helmet Use Behaviour in Elderly Patients After a Bicycle, E-bike, or Moped Accident
A study testing Educational video in people with Helmet Use and Cyclists, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helmet Use, Cyclists, Video Information
- What is being tested?
- Educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Sep 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Linguistic barrier
- Illiteracy or blindness
- Helmet use during the accident
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Leiden University Medical Center
Leiden
Erasmus University Medical Center
Rotterdam
Haaglanden Medical Center
The Hague
About this study
Official title: The Effect of Visual Patient Education on Helmet Use Behaviour in Elderly Patients After a Bicycle, E-bike, or Scooter Accident: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Helmet Use, Cyclists, Video Information
- Being tested
- Educational video
- Keywords
- Helmet use, Emergency Department, behavioral change, educational intervention, video intervention
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational video |
| Control Group | No intervention | Participants in the control group will receive standard emergency care alone without the educational video. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helmet use
Self-reported helmet use (single-item survey question, yes/no), assessed 6 months after ED visit.
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helmet UseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Atalik-Hoogeweij, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773545
- Sponsor's protocol ID
- MEC-2021-0457
- Acronym
- HelmED RCT
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be entered and managed via Castor. Investigators will be able to review pseudo-anonymized data after 2-step-verification log-in.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Patient Education on Helmet Use Behaviour in Elderly Patients After a Bicycle, E-bike, or Scooter Accident: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07773545
- Acronym / sponsor ID
- HelmED RCT / MEC-2021-0457
- Conditions
- Helmet Use, Cyclists, Video Information
- Keywords
- Helmet use, Emergency Department, behavioral change, educational intervention, video intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational video | Experimental | Behavioral: Educational videoParticipants assigned to the intervention group will receive standard emergency care in addition to a short online educational video promoting helmet use. |
| Control Group | No intervention | –Participants in the control group will receive standard emergency care alone without the educational video. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Linguistic barrier
- Illiteracy or blindness
- Helmet use during the accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoThe 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. | Behavioural | Educational video |
Primary outcome
Helmet use
Time frame: 6 months
Self-reported helmet use (single-item survey question, yes/no), assessed 6 months after ED visit.
1 secondary outcome
Patient attitude towards helmet use
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be entered and managed via Castor. Investigators will be able to review pseudo-anonymized data after 2-step-verification log-in.
Related trials for Helmet Use
Recruiting
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Substance Use Disorder (SUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Helmet Use and Cyclists, run by Erasmus Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helmet use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.