NCT Number: NCT07773545
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.
This study is active but is not currently recruiting participants.
Notify Me60 year and older
All sexes
Interventional
Not applicable
Leiden University Medical Center, Leiden, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Self-reported helmet use (single-item survey question, yes/no), assessed 6 months after ED visit.
Time frame: 6 months
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)
Erasmus Medical Center
Other
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
Acronym: HelmED RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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