Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000316505
Ethics application status
Approved
Date submitted
19/03/2015
Date registered
7/04/2015
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Date results information initially provided
11/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identification of clinical data useful to predict the development of prolonged symptoms after a concussion, at the time of initial assessment in the Emergency Department.
Scientific title
For children who have sustained a concussion, what are the factors that predict which children will develop post-concussive syndrome?
Secondary ID [1] 286340 0
Nil
Universal Trial Number (UTN)
U1111-1168-1919
Trial acronym
Take CARe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Concussion 294456 0
Post-Concussive Syndrome 294457 0
Condition category
Condition code
Injuries and Accidents 294765 294765 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
We will examine factors that predict post-concussive syndrome in children aged 5-18. We will assess children at presentation to the emergency department and again at 1-4 days, 2-weeks, 1- month, and 3-months post-injury.

We will be observing post-concussive symptoms at each time point. This can include a broad range of symptoms, such as: somatic (eg, headache, vomiting); cognitive (eg, feeling like in fog); emotional (eg, lability); Physical signs (eg, loss of consciousness, amnesia); Behavioural changes (eg, irritability); Cognitive impairment (eg, slowed reaction times); Sleep disturbance (eg, insomnia).

Intervention code [1] 291394 0
Not applicable
Comparator / control treatment
The comparator group will be children aged 5-18 who have sustained a concussion and do NOT develop post-concussive syndrome. The observational period for ALL participants will be 3-months post-injury.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294519 0
The presence of post-concussive symptoms at 2-weeks post-injury. This will be assessed by the Post Concussive Symptom Inventory (PCSI), a reliable and validated measure of post-concussive symptoms for both children and adults.
Timepoint [1] 294519 0
2-weeks post-injury
Secondary outcome [1] 313552 0
Longitudinal recovery trajectories for PCS and main symptoms. Post-concussive symptoms will be assessed at each time point using the PCSI. We will also track daily symptoms by providing patients/parents with a PCSI diary for them to fill out every day between time point 1 (1-4 days post injury) and time point 2 (2-weeks post-injury). This can be extended if they continue to be symptomatic at time point 2.
Timepoint [1] 313552 0
1-4 days, 2-weeks, 1-month, and 3-months post-injury
Secondary outcome [2] 313553 0
Presence of post concussive brain dysfunction (composite outcome combining symptoms, neurocognitive tests and balance-coordination examination results). This will be assessed using the Sports Concussion Assessment Tool, 3rd edition (SCAT3) and Cogsport, a computerized neurocognitive assessment tool specifically developed for concussion assessment.
Timepoint [2] 313553 0
1-4 days, 2-weeks, 1-month and 3-months post-injury
Secondary outcome [3] 313554 0
Presence of post traumatic symptoms, which will be measured using the Child Post-Traumatic Stress Scale (CPSS).
Timepoint [3] 313554 0
1-4 days, 2-weeks, 1-month, and 3-months post-injury
Secondary outcome [4] 313555 0
A measure of quality of life, which is measured using the Pediatric Quality of Life Inventory (PedsQL).
Timepoint [4] 313555 0
1-4 days, 1-month, and 3-months post-injury
Secondary outcome [5] 313875 0
Problematic behavior, which will be measured using the Child Behavior Checklist (CBCL)
Timepoint [5] 313875 0
2-weeks, one-month, and three-months
Secondary outcome [6] 313876 0
Parental mental health, which will be assessed using the Kessler Psychological Distress Scale (K10).
Timepoint [6] 313876 0
2-weeks, one-month, and 3-months
Secondary outcome [7] 313877 0
Fatigue will be measured using the PedsQL Multidemensional Fatigue Scale.
Timepoint [7] 313877 0
1-4 days, one-month, and three-months
Secondary outcome [8] 313878 0
We will measure family burden. To do this, we will collect data on number of school days missed (participants), sports activities missed (participants), school days missed (participants), work days missed (parents), additional carers required (parents).
Timepoint [8] 313878 0
one-month and 3-months

Eligibility
Key inclusion criteria
Patients aged 5-18 years who present to the ED for a concussion sustained in the previous 48 hours
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intubated patients on arrival to the ED

Need of neurosurgical operative intervention or general anaesthesia for injury management

Presence of structural/haemorrhagic intracranial injury on CT scan brain

Clinical evidence of CSF leak

Intellectual disability with inability to complete the testing measures.

Injury resulting from child abuse or assault

Alcohol or drug intoxication at time of presentation to the ED

Insufficient understanding of English as per assessment by the treating physician/research assistant in the ED

Multiple trauma

No clear history of trauma as primary event (eg, seizure, syncope or migraine as primary event)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The expected number of 200 patients for this study has been estimated based on data from the current ongoing Australasian Prospective Head Injury Study (APHIRST) at the Royal Children's Hospital Emergency Department (i.e., the possibility of patients’ recruitment during daytime (from 8 am to 10 pm) and the seasonal variation in sport-related concussions).

Categorical variables will be described as percentages and 95% confidence intervals. Continuous variables will be described as mean and standard deviation or median and interquartile range, according to their parametric or non-parametric distribution, respectively. Comparisons will be performed by means of Chi-square test for categorical variables. T-test will be used to compare continuous variables with parametric-distribution, while Mann-Whitney test will be used to compare those with non-parametric distribution.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/08/2013
Date of last participant enrolment
Anticipated
31/12/2016
Actual
23/06/2017
Date of last data collection
Anticipated
Actual
28/09/2017
Sample size
Target
200
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3559 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 9364 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 290915 0
Charities/Societies/Foundations
Name [1] 290915 0
Royal Children's Hospital Foundation
Country [1] 290915 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Franz Babl
Address
Murdoch Childrens Research Institute
50 Flemington Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 289595 0
Individual
Name [1] 289595 0
Professor Vicki Anderson
Address [1] 289595 0
Murdoch Childrens Research Institute
50 Flemington Road, Parkville VIC 3052
Country [1] 289595 0
Australia
Secondary sponsor category [2] 289596 0
Individual
Name [2] 289596 0
Dr. Silvia Bressan
Address [2] 289596 0
Murdoch Childrens Research Institute
50 Flemington Road, Parkville VIC 3052
Country [2] 289596 0
Australia
Secondary sponsor category [3] 289597 0
Individual
Name [3] 289597 0
Dr. Michael Takagi
Address [3] 289597 0
Murdoch Childrens Research Institute
50 Flemington Road, Parkville VIC 3052
Country [3] 289597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292517 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 292517 0
Royal Children's Hospital
50 Flemington Road, Parkville VIC 3052
Ethics committee country [1] 292517 0
Australia
Date submitted for ethics approval [1] 292517 0
Approval date [1] 292517 0
02/07/2013
Ethics approval number [1] 292517 0
33122

Summary
Brief summary
The Predictors of Post Concussive Syndrome Protocol that we are developing concerns a study on the derivation and validation of a clinical prediction rule for PCS in children aged 5 to 18 years, who present to the ED for concussion.

In order to assist clinicians in identifying patients at high risk of PCS, who will benefit from a closer follow up and early referral to a dedicated concussion clinic, we set out to derive and validate a clinical prediction rule based on pre-injury and injury-related data to be used in the ED.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55694 0
Dr Michael Takagi
Address 55694 0
Murdoch Childrens Research Institute
Emergency Medicine Research Group
50 Flemington Road, Parkville VIC 3052
Country 55694 0
Australia
Phone 55694 0
+613 9345 4901
Fax 55694 0
Email 55694 0
[email protected]
Contact person for public queries
Name 55695 0
Dr Michael Takagi
Address 55695 0
Murdoch Childrens Research Institute
Child Neuropsychology Research Group
50 Flemington Road, Parkville VIC 3052
Country 55695 0
Australia
Phone 55695 0
+613 9345 4901
Fax 55695 0
Email 55695 0
[email protected]
Contact person for scientific queries
Name 55696 0
Dr Michael Takagi
Address 55696 0
Murdoch Childrens Research Institute
Child Neuropsychology Research Group
50 Flemington Road, Parkville VIC 3052
Country 55696 0
Australia
Phone 55696 0
+613 9345 4901
Fax 55696 0
Email 55696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share individual study participants data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a prospective, longitudinal, cohort study of postconcussive symptoms in children: The Take C.A.Re (Concussion Assessment and Recovery Research) study.2016https://dx.doi.org/10.1136/bmjopen-2015-009427
EmbaseProtocol for a prospective, longitudinal, cohort study of recovery pathways, acute biomarkers and cost for children with persistent postconcussion symptoms: The Take CARe Biomarkers study.2019https://dx.doi.org/10.1136/bmjopen-2018-022098
N.B. These documents automatically identified may not have been verified by the study sponsor.