|- candidate number||23263|
|- NTR Number||NTR5465|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-okt-2015|
|- Secondary IDs||MEC-2015-546 Medische Ethische Commissie|
|- Public Title||Mild traumatic brain injury and Outcomes with VIsual patient Education (MOVIE), a randomised controlled trial.|
|- Scientific Title||Mild traumatic brain injury and Outcomes with VIsual patient Education (MOVIE), a randomised controlled trial.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Mild traumatic brain injury|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2015|
|- planned closingdate||1-mrt-2017|
|- Target number of participants||1152|
|- Interventions||An online video with discharge instructions will be shown, and/or a link to the video will be provided in the leaflet. |
|- 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)
|- Timepoints||1 week and 3 months|
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES||MD Amber. E. Hoek|
|- CONTACT for SCIENTIFIC QUERIES||MD Amber. E. Hoek|
|- Sponsor/Initiator ||Erasmus Medical Center, Medical Center Haaglanden, Sint Franciscus Gasthuis, Westfriesgasthuis Hoorn|
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||25-okt-2015 - 23-dec-2015|