Mild traumatic brain injury and Outcomes with VIsual patient Education (MOVIE), a randomised controlled trial.
Not yet recruiting
- Conditions
- Mild Traumatic Brain Injury (MTBI)Licht traumatische Hoofd-/Hersenletsel (LTH)
- Registration Number
- NL-OMON26501
- Lead Sponsor
- Erasmus Medical CenterMedical Centre HaaglandenSint Franciscus Vlietland Groep Westfriesgasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1152
Inclusion Criteria
Patients attending the ED of the participating centres with MTBI according to the definition of the Dutch institute for healthcare improvement (CBO):
- Every trauma to the head with a Glasgow Coma Scale score at first examination greater than 13,
Exclusion Criteria
- Intracranial abnormality on CT-scan
- Focal Neurological deficit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurence and severity of post-concussion symptoms measured by the ‘Rivermead Post-Concussion Questionnaire’ at 1 week and 3 months
- Secondary Outcome Measures
Name Time Method - Return to usual activities (absence of work questionnaire). <br /><br>- Return visit to the ED/visit to GP/outpatient clinic. <br /><br>- Understanding of diagnosis by 3 questions about MTBI<br /><br>- Anxiety and Depression in patients with MTBI according to HADS questionnaire<br /><br>- Patient satisfaction on a 10-point scale<br /><br>- Quality of life by Short Form-36 Health Survey (SF-36)<br /><br>- Costs of intervention and productivity costs (costs of absence from work and reduced productivity while at work)