Our hypothesis is that receiving written and audio-visual patient information will reduce the frequency and severity of post-concussion symptoms in patients with MTBI.
ID
Bron
Verkorte titel
Aandoening
Mild Traumatic Brain Injury (MTBI)
Licht traumatische Hoofd-/Hersenletsel (LTH)
Ondersteuning
Medical Centre Haaglanden
Sint Franciscus Vlietland Groep
Westfriesgasthuis
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The occurence and severity of post-concussion symptoms measured by the ‘Rivermead Post-Concussion Questionnaire’ at 1 week and 3 months
Achtergrond van het onderzoek
Rationale: Mild traumatic brain injury (MTBI) is a common diagnosis at the Emergency department (ED). It is estimated that approximately 85,000 patients in the Netherlands suffer from MTBI each year, of whom 12,580 patients are seen at the ED of Dutch hospitals. In the first weeks to months after MTBI 17-78% of patients suffer from post-concussion symptoms. Previous studies indicate that knowledge and understanding of post-concussion symptoms by the patient may reduce incidence and/or severity of such complaints.
Objective: Our main objective is to study the effect of patient information on occurrence and severity of post-concussion symptoms in patients with MTBI.
Study design: A multi-centre prospective study will be conducted in two phases. Phase 1 is measurement of standard care. Phase 2 is a Randomized Controlled Trial (RCT), comparing standard management, with two intervention groups.
Study population: All patients >18 years with MTBI attending the ED may be eligible for inclusion.
Intervention (if applicable): Patients will receive a printed folder (written information) in the first intervention group, and in the second intervention group patients will receive written information and they will be asked to watch a video explaining the course of posttraumatic symptoms.
Main study parameters/endpoints: The primary outcome will be the occurrence and severity of post-concussion symptoms at one week and three months after attending the ED.
Doel van het onderzoek
Our hypothesis is that receiving written and audio-visual patient information will reduce the frequency and severity of post-concussion symptoms in patients with MTBI.
Onderzoeksopzet
1 week and 3 months
Onderzoeksproduct en/of interventie
An online video with discharge instructions will be shown, and/or a link to the video will be provided in the leaflet.
Publiek
Amber. E. Hoek
P.O. Box 2040,
Rotterdam 3000 CA
The Netherlands
+3110-7039222
a.e.hoek@erasmusmc.nl
Wetenschappelijk
Amber. E. Hoek
P.O. Box 2040,
Rotterdam 3000 CA
The Netherlands
+3110-7039222
a.e.hoek@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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,
- Post-traumatic loss of consciousness less than 30 minutes,
- and Post-traumatic amnesia not more than 24 hours
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Intracranial abnormality on CT-scan
- Focal Neurological deficit
- Language barrier
- No informed consent
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5355 |
NTR-old | NTR5465 |
Ander register | Medische Ethische Commissie : MEC-2015-546 |