Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001277134
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
16/09/2019
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Caring for Children After a Concussion using a Technology-Assisted Clinical Care Pathway
Scientific title
Standardizing care for children with concussion: Uptake, Outcomes, and Health Care Impacts of a Patient-Driven Technology-Assisted Clinical Care Pathway
Secondary ID [1] 299030 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 314042 0
Post-concussion syndrome 314043 0
Condition category
Condition code
Neurological 312427 312427 0 0
Other neurological disorders
Injuries and Accidents 312469 312469 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve a pre- and post- intervention design to evaluate the implementation of a mobile app eHealth tool. This intervention will guide participants through recovery after a concussion injury. In order to design an effective eHealth intervention, the following processes will be undertaken;
1.An audit of concussion presentations to the Queensland Children's Hospital (QCH) Emergency Department (ED) will provide demographic information and the number of paediatric concussion diagnoses in this location within a set period.
2. Semi-structured qualitative interviews will be conducted by the Research Assistant at the QCH, Centre for Children's Health Research, or via telephone or videoconferencing with the following groups;
i. Up to 10 patients/families who have sustained a concussion. Patients will be recruited from the Mild Traumatic Brain Injury service
ii. Up to 15 ED Health Care Professionals. These will be volunteers recruited via workplace newsletter and flyers.
iii. Up to 10 other important stakeholders involved the management of concussion within QCH and the community. eg. GPs, Trauma Service, physiotherapy. These participants will be recruited by directly approaching staff known within clinical networks.

Interviews with patients/families will include demonstration of a similar app, static website and information website to understand the type and format of e-information that patients and families would find useful during the recovery process. Information gained from all of these interviews will be used to modify and implement a post-concussion clinical pathway. The interviews will be done over a period of three months

The pre-intervention phase of the study will recruit 150 participants who register for the project on the study's informational website via the project flyer provided during their ED visit. The Research Assistant will initiate these surveys by entering participant's email address into REDCap.

The intervention phase of the study will commence once 150 participants have enrolled in the pre-intervention phase. 150 participants will register for the intervention phase via a specific project flyer provided during their ED visit which will include instructions on how to download a mobile app.

In both the pre-intervention and intervention phases, participants will complete surveys received either via email (pre-intervention) or on the app (intervention). These surveys will track and monitor their concussion symptoms and recovery for up to 3 months following enrolment. The surveys will include; fortnightly Post Concussion Symptom Inventory, one Satisfaction with Care survey, and two Quality of Life questionnaires. Adherence in both phases will the data collected on REDCap (from both survey completion and app engagement)
Intervention code [1] 315302 0
Rehabilitation
Comparator / control treatment
Participants in the pre-intervention phase will receive the same survey type and frequency as the intervention but via a different method. ie. electronic email surveys versus app survey completion. Although similar information on concussion will be available to both groups, the app will have the ability to provide tailored information based on the survey responses.
Control group
Active

Outcomes
Primary outcome [1] 321079 0
Time to symptom resolution (in days) will be assessed by calculating time from injury to symptom resolution. This will be based on when participants confirm they have returned to their pre-injury status
Timepoint [1] 321079 0
This will be done once during a three month period, based on response to the question 'have you returned to your pre-injury status?' This question will be asked every 2 weeks until the participant answers 'yes'.
Primary outcome [2] 321110 0
Satisfaction of care received during their ED visit for their concussion injury. This will be assessed by a Satisfaction with Care survey of 14 questions developed by the research team relevant to the study setting.
Timepoint [2] 321110 0
2 weeks post-enrolment
Secondary outcome [1] 373905 0
Post Concussion Symptom Inventory (PCSI) total score



Timepoint [1] 373905 0
Measured every two weeks for up to three months
Secondary outcome [2] 373906 0
Paediatric Quality of Life (PedsQL™)
Timepoint [2] 373906 0
One month and three months post-enrolment
Secondary outcome [3] 374026 0
Measurement of ED clinician uptake of the clinical pathway. This will be assessed by comparing the number of Fact Sheets issued to the number of patients diagnosed with concussion during study period.
Timepoint [3] 374026 0
Upon completion of study enrolment in the pre-intervention and intervention phase. This is expected to be twelve months from first enrolment.
Secondary outcome [4] 374032 0
Composite secondary outcome; uptake of webpage;
i. Number of patients enrolled compared to number of Information Sheets issued based on enrolment numbers as per REDCap database.
ii. Number of unique webpage hits from IP address compared to number of Fact Sheets issued. This will be done via website analytics
Timepoint [4] 374032 0
Upon completion of study enrolment in the pre-intervention and intervention phase. This is expected to be twelve months from first enrolment.

Eligibility
Key inclusion criteria
Children between the ages of 0-16 seen in Queensland Children's Hospital Emergency Department who have been diagnosed with a concussion injury and discharged home
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants over the age of 16
Participants admitted to hospital for their concussion injury
Patients not seen at Queensland Children's Hospital Emergency Department

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:. Between 15 and 30% of children remain symptomatic at 4 weeks (Barlow, 2015). A sample size of 51 to 126 per group is required. Power should be sufficient to detect a 5% decrease in survival of symptoms (i.e. 1 week earlier symptom resolution) over 4 weeks, with 80% power and type I error of 5%. Power will also be sufficient for secondary outcomes. A sample of 150 per group will allow for a 20% attrition rate.

Characteristics of patients will be summarized by exposure status (i.e., control versus intervention) to allow for consideration of selection biases. Relevant comparisons will include important patient characteristics, including age and sex. Primary analyses will involve comparisons of primary and secondary outcomes across periods prior to versus after the implementation intervention. This will be accomplished using survival curve analyses for time to symptom resolution. Other outcomes will be examined using generalized linear mixed models fixed effects for phase. Linear models will be used for continuous outcomes, and Poisson or logistic regression models for proportion and binary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/09/2019
Date of last participant enrolment
Anticipated
30/09/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
300
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14558 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 27573 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303565 0
Charities/Societies/Foundations
Name [1] 303565 0
Foundation for Children
Country [1] 303565 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Karen Barlow
Address
The University of Queensland Child Health Research Centre
Centre for Children's Health Research
Level 6, CCHR, Graham Street
South Brisbane, 4101, Queensland
Country
Australia
Secondary sponsor category [1] 303689 0
None
Name [1] 303689 0
Address [1] 303689 0
Country [1] 303689 0
Other collaborator category [1] 280913 0
Hospital
Name [1] 280913 0
Queensland Children's Hospital
Address [1] 280913 0
501 Stanley Street
South Brisbane, 4101, Queensland
Country [1] 280913 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304096 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 304096 0
Ethics committee country [1] 304096 0
Australia
Date submitted for ethics approval [1] 304096 0
16/05/2019
Approval date [1] 304096 0
16/07/2019
Ethics approval number [1] 304096 0
HREC/LNR/19/QCHQ/52434

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95798 0
A/Prof Karen Barlow
Address 95798 0
The University of Queensland Child Health Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane, 4101, Queensland
Country 95798 0
Australia
Phone 95798 0
+61 7 3069 4786
Fax 95798 0
Email 95798 0
k.barlow@uq.ed.au
Contact person for public queries
Name 95799 0
Karen Barlow
Address 95799 0
The University of Queensland Child Health Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane, 4101, Queensland
Country 95799 0
Australia
Phone 95799 0
+61 7 3069 4786
Fax 95799 0
Email 95799 0
k.barlow@uq.ed.au
Contact person for scientific queries
Name 95800 0
Karen Barlow
Address 95800 0
The University of Queensland Child Health Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane, 4101, Queensland
Country 95800 0
Australia
Phone 95800 0
+61 7 3069 4786
Fax 95800 0
Email 95800 0
k.barlow@uq.ed.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data;
- Demographic information
- Injury characteristics
- Outcome measures
When will data be available (start and end dates)?
Upon publication of the major outcome paper of the trial with no end date determine
Available to whom?
Researchers with a reasonable research question will be considered
Available for what types of analyses?
Any reasonable research question
How or where can data be obtained?
The data will be shared through mendeley data using a link from the Principal Investigator (A/Prof Karen Barlow) who can be contacted via email of k.barlow@uq.edu.au or uq_ABiC@uq.edu.au


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
No additional documents have been identified.