|- candidate number||15220|
|- NTR Number||NTR4100|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2013|
|- Secondary IDs||P12.156 METC LUMC |
|- Public Title||Brain Power: functioning after traumatic brain injury|
|- Scientific Title||Brain Power: functioning after traumatic brain injuryin adolescents and young adults: a comparison with orthopedic injuries and healthy peers|
|- ACRONYM||Brain Power|
|- hypothesis||Youth and young adults with traumatic brain injury more often have fatigue, anxiety, depression and are less physically active than youths with an orthopedic injury or healthy peers.|
|- Healt Condition(s) or Problem(s) studied||Traumatic brain injury, Fatigue, Anxiety, Depression, Physical activity, Sleepproblems|
|- Inclusion criteria||All consecutive patients aged 12-25 years registered with the diagnosis traumatic brain and/or head injury between March 2012 and March 2013. All consecutive patients aged 12-25 years registered with an orthopaedic injuries (fracture to the upper or lower extremities) with no head injury at time of trauma or surgical intervention.
The healthy group will consist of peers selected by the TBI group with no history of orthopaedic or traumatic brain injury in the past year.
|- Exclusion criteria||Excluded are patients with multiple visits in the same year to the ER for other head injuries or orthopaedic injuries; patients with other medical conditions with an impact on functioning (such as congenital disorders, rheumatic disease, chronic fatigue syndrome, epilepsy); patients who are not fluent in Dutch or patients having an intellectual level whereby they cannot independently fill out the questionnaires (IQ < 70). |
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2013|
|- planned closingdate||31-dec-2013|
|- Target number of participants||400|
|- Interventions||internet questionnaire|
|- Primary outcome||fatigue, depression, anxiety, sleep disorders, physical activity, |
|- Secondary outcome||quality of live|
|- Timepoints||one time questionnaire 6 to 18 months after injury|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Frederieke Markus, van|
|- CONTACT for SCIENTIFIC QUERIES|| Frederieke Markus, van|
|- Sponsor/Initiator ||Sophia Rehabilitation Centre|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Traumatic brain injury (TBI) is the leading cause of disability in youths today. The symptoms include impairments in motor skills, cognition, behaviour and social-emotional development. The incidence of these symptoms in youth in The Netherlands is not known. There is a delay in recognition of these symptoms leading to long term insufficient knowledge of the relationship of symptoms to the original injury. The disabilities are broad and often vague. They lead to limitations in activities and participation.
Objective: To establish the incidence and consequences (impairments op body functions, limitations in participation) of traumatic brain injury in children and youth in a region of The Netherlands as well as the incidence of the same symptoms in a group of children and youth with an orthopaedic injury and a group of healthy peers.|
Study design: Cross-sectional, multicenter study.
Study population: All consecutive patients aged 12-25 years registered with the diagnosis traumatic brain injury and trauma capitas between 6 and 18 months post injury (approximately October 2010 and October 2011 in one of two hospitals in The Hague. In the same period a cohort of 100 orthopaedic patients as well as 200 healthy peers will be used as the control group.
Main study parameters/endpoints: The main study parameters are questionnaires assessing body functions (fatigue: Checklist Individual Strength; headaches, depression and anxiety: YSR/ASR; sleep disturbances: Holland Sleep Disorder List; level of physical activity: SQUASH); overall quality of life: TAAQOL/TACQOL and a general questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants will fill out questionnaires (paper version or digital/online). The total time to complete the questionnaires should be limited to 45-60 minutes. The benefit for the patient is that through a better understanding of long term consequences of TBI better treatment protocols can be developed. Through a better understanding of the consequences after trauma secondary prevention can be initiated earlier after injury.
|- Main changes (audit trail)|
|- RECORD||31-jul-2013 - 16-sep-2013|