No registrations found.
ID
Source
Brief title
Health condition
Mild Traumatic Brain Injury (MTBI)
Licht traumatische Hoofd-/Hersenletsel (LTH)
Sponsors and support
Medical Centre Haaglanden
Sint Franciscus Vlietland Groep
Westfriesgasthuis
Intervention
Outcome measures
Primary outcome
The occurence and severity of post-concussion symptoms measured by the ‘Rivermead Post-Concussion Questionnaire’ at 1 week and 3 months
Secondary outcome
- Return to usual activities (absence of work questionnaire).
- Return visit to the ED/visit to GP/outpatient clinic.
- Understanding of diagnosis by 3 questions about MTBI
- Anxiety and Depression in patients with MTBI according to HADS questionnaire
- Patient satisfaction on a 10-point scale
- Quality of life by Short Form-36 Health Survey (SF-36)
- Costs of intervention and productivity costs (costs of absence from work and reduced productivity while at work)
Background summary
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.
Study objective
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.
Study design
1 week and 3 months
Intervention
An online video with discharge instructions will be shown, and/or a link to the video will be provided in the leaflet.
Amber. E. Hoek
P.O. Box 2040,
Rotterdam 3000 CA
The Netherlands
+3110-7039222
a.e.hoek@erasmusmc.nl
Amber. E. Hoek
P.O. Box 2040,
Rotterdam 3000 CA
The Netherlands
+3110-7039222
a.e.hoek@erasmusmc.nl
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,
- Post-traumatic loss of consciousness less than 30 minutes,
- and Post-traumatic amnesia not more than 24 hours
Exclusion criteria
- Intracranial abnormality on CT-scan
- Focal Neurological deficit
- Language barrier
- No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5355 |
| NTR-old | NTR5465 |
| Other | Medische Ethische Commissie : MEC-2015-546 |