Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001266550
Ethics application status
Approved
Date submitted
5/08/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating implementation and clinical outcomes for the Murdoch Childrens Research Institute Concussion Centre
Scientific title
The Concussion Clinic Trial: Evaluating implementation and clinical outcomes of a digital health application and individualised multimodal interventions in children aged 8-17 years with persistent concussion symptoms
Secondary ID [1] 312688 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up to the Concussion Essentials RCT Study (ACTRN12617000418370) also undertaken at Murdoch Childrens Research Institute from 2019-2024

Health condition
Health condition(s) or problem(s) studied:
Concussion 334689 0
Condition category
Condition code
Public Health 331256 331256 0 0
Health service research
Neurological 331257 331257 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 (less than 2 weeks post-injury):
Parents/participants who are less than 2 weeks at the time of recruitment/referral enrolment will:
1. Be asked to complete pre-treatment questionnaires and download the HeadCheck app. The HeadCheck app requires login details, which allows data entered in the app to be linked to the user. Parents/participants will be asked for consent to access their data from the HeadCheck app. Allowing the study to access this data will be optional. Data will be recorded as missing for parents/participants who do not consent to study access of this data.
2. Complete a phone review with a study staff member at 2-3 weeks (14-21 days) post-injury to monitor symptoms, recovery, and activity participation. A phone review form on REDCap, with prompts will be used to guide this conversation and determine need for further clinical input. Any clinical issues will be escalated to a study clinician who may make additional phone contact with the participant if necessary. A phone review is completed in Phase 1 as it is expected that ~70% of children and adolescents will recover and return to usual activities in the 2-3 weeks post-injury. A phone review will help to distinguish between those who have recovered and those who may benefit from further clinical intervention (i.e., Phase 2).
a. If the parent/guardian reports (i) a complete recovery, (ii) the participant has successfully returned to all usual activities without symptoms, and (iii) family have no concerns, they will be discharged from the service and sent completion questionnaires to complete via REDCap. If the questionnaires are not completed within 1-week of discharge from the service, they will receive two reminder emails/text messages and two reminder phone calls before being considered lost to follow up. REDCap is its own app/database which utilises easily accessible online surveys for research purposes. It is separate to HeadCheck
b. If the parent/guardian reports persisting symptoms and/or does not meet the criteria outlined above, the participant will enter Phase 2.
Phase 2 (>2 weeks to 3 months post-injury):
Parents/participants who are >2 weeks to 3 months post-injury at the time of recruitment/referral enrolment will:
1. Book an initial appointment within the clinic. A link to complete pre-treatment questionnaires will be sent to participants with their appointment email.
2. Complete an initial appointment with the trial team (from 21-days post-injury). This initial appointment will be up to 1.5 hours long and may take up to 2 hours.
3. Continue with the CE/CE+ intervention (until symptom resolution, target discharge date by 8-weeks for those <3 months post-injury, target discharge date by 12-weeks for those >3 months post-injury).
CE and CE+ refer to the names of a three-module intervention for early (CE) and chronic (CE+) persisting post-concussion symptoms. These interventions share the same three treatment modules (Education + Strategies - 'Concussion Essentials', Physiotherapy, Psychology). The key differences between these two interventions are (i) the length of time they were delivered (CE = up to 8 session intervention, CE+ = up to 12 session intervention), and (ii) the psychological treatment adopted (CE = Cognitive Behavioural Therapy, CE+ = Acceptance and Commitment Therapy). The CE/CE+ intervention provide individualised, symptom-targeted treatment. This means that the order and number of modules provided will differ from participant to participant. Every participant completes an initial session, which is interdisciplinary (physio and psychologist present) and includes an education + strategies module and physiotherapy module. Ongoing treatment decisions are made in weekly multi-disciplinary meetings, guided by clinician impression and symptom ratings. Participants and their families will largely complete intervention sessions via face-to-face consultations but where appropriate, will be provided the option to complete sessions via telehealth (e.g. Psychology modules).

Education + Strategies - 'Concussion Essentials' module: Participants will receive education, strategies, and recommendations to manage various common symptoms following concussion, including headaches, fatigue, and sleep difficulties. Return to school and return to physical activity support is also provided within this module.

Physiotherapy module: Participants will receive treatment targeting physiological, vestibular, ocular-motor, and cervicogenic systems, as required. This includes supported graded return to aerobic exercise. Participant may also receive a high-level return to play session dependent on the sport that they are returning to. This treatment is delivered by a physiotherapist and/or exercise physiologist with specific experience and training in concussion management.
Physiotherapy exercises may include cervical, ocular, physiological, vestibular, or sport-specific drills/exercises. Treatment approaches of these physical systems are outlined below:
• Physiological treatment: gradual increase in sub symptom cardiovascular exercise. A daily program of cardiovascular exercise (walk, run, bike, circuit etc.) may be prescribed at 85% of the treadmill sub-maximal test heart rate cut-off (monitored by heart rate monitors). Advice will be given on gradual exercise progression.
• Cervicogenic treatment: Manual therapy may be administered at the clinic reviews. Home program may include sensorimotor training, strengthening, motor control exercises.
• Ocular-motor treatment: Treatment involves ocular motor retraining. Daily home program may include the following ocular exercises: saccades, vergence, and smooth pursuit.
• Vestibular treatment: Treatment will focus on simple vestibular exercises which will progress to more complex tasks. Daily home program may be prescribed which could include balance exercises, and motion sensitivity exercises. (NB. If participants have significant impairment in the cervical and ocular modules they will not be able to commence vestibular management until their other systems normalise.)
• Return to sport: Specific return to sport drills incorporating the systems above may be prescribed to facilitate appropriate return to sport. Note that there will be slightly different protocols dependent on sports.

Psychology module: Participants will receive evidence-based treatment based on principles of cognitive behaviour therapy (CBT) and/or Acceptance and Commitment Therapy (ACT). This module targets psychological symptoms (e.g., anxiety, depression, stress, avoidance) and is delivered by psychologists with specific experience and training in concussion management.
a. Intervention sessions will be delivered weekly.
b. Sessions may range from 30-to-90-minutes in length and include one or two of the available treatment modules.
c. Specialist medical consultation will be available, if required (e.g., RCH rehab medicine, RCH psychiatry).
d. Discharge - refer to discharge information.
4. Following discharge from the service, families will be sent completion questionnaires and complete an optional semi-structured interview.
Intervention code [1] 329215 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339027 0
Acceptability
Timepoint [1] 339027 0
Conducted post discharge from intervention – timeframe will differ for each participant depending on amount of intervention needed. Participants are offered up to a maximum of 16-weeks of the CE/CE+ intervention.
Primary outcome [2] 339129 0
Adoption
Timepoint [2] 339129 0
Administrative data will be collected ongoing during participation period of the study for each individual participant.

Semi-structured interviews will be conducted post discharge from the study at resolution of symptoms or referral to another specialist health service.
Primary outcome [3] 339130 0
Appropriateness
Timepoint [3] 339130 0
Semi-structured interviews will be conducted post discharge from the study at resolution of symptoms or referral to another specialist health service.

Clinical focus groups to be conducted at 6 and then 12 months after beginning of the study.
Secondary outcome [1] 438302 0
Change in post-concussive symptoms
Timepoint [1] 438302 0
Collected weekly during participation period of the study for each individual participant, up to a maximum of 16 weeks post-intervention commencement.
Secondary outcome [2] 438303 0
Return to school
Timepoint [2] 438303 0
Collected weekly during participation period of the study for each individual participant, up to a maximum of 16 weeks post-intervention commencement.
Secondary outcome [3] 438304 0
Accessibility of the Sports Concussion Office Assessment Tool (SCOAT) 6 (child and parent)
Timepoint [3] 438304 0
The Child SCOAT6 and SCOAT6 are assessment tools that will be administered once, on entry to the treatment phase of the concussion clinic (i.e., Phase 2). Questionnaires that are included in the SCOAT assessment will be re-administered at discharge from the intervention.
Secondary outcome [4] 438669 0
Feasibility (additional primary outcome)
Timepoint [4] 438669 0
Collected ongoing during individuals participation in the study.

Target and actual discharge date will be recorded in REDCap. Date of referral and date of first appointment will also be recorded in REDCap.
Secondary outcome [5] 438670 0
Fidelity (additional primary outcome)
Timepoint [5] 438670 0
At the conclusion of the study
Secondary outcome [6] 438671 0
Implementation costs (additional primary outcome)
Timepoint [6] 438671 0
Staff costs will be assessed at the conclusion of the study.

Individual participant consumer costs will be collected at discharge from study.
Secondary outcome [7] 438676 0
Return to sport/leisure
Timepoint [7] 438676 0
Collected weekly during participation period of the study for each individual participant, up to a maximum of 16 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
• Age between 8-17 years (or 18 year olds who are still in high school)
• Diagnosis of concussion, confirmed by:
o Evidence of a blow to the head or impulsive force transmitted to the head, and
o One or more of the following:
Symptoms
• Somatic (e.g., headaches)
• Cognitive (e.g., feeling like in a fog)
• Emotional symptoms (e.g., lability)
Physical signs
• Loss of consciousness
• Amnesia
- Balance impairment (e.g., gait unsteadiness)
- Behavioural changes (e.g., irritability)
- Cognitive impairment (e.g., slowed reaction times)
- Sleep/wake disturbance (e.g., somnolence, drowsiness)
o No abnormalities on CT or MRI brain imaging, if performed
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of any comorbidity that clinicians deem will be more appropriate for exclusive treatment within another health service/department (e.g., a patient with Functional Neurological Disorder (FND) may be referred to the FND team within the Victorian Paediatric Rehabilitation Service at Monash Health; or a patient with severe psychiatric diagnosis may be referred to RCH Psychiatry).

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)
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
Other
Other design features
Phase 1 (HeadCheck) is for any potential study participant referred via ED or other source with a concussion who uses the app. Phase 2 (the intervention) is for participants with concussion who have persistent symptoms (PCS).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our previous research suggests that an achievable recruitable rate of approximately 260 children per year. This number is both financially and logistically feasible. With N=260, we will have accuracy of 0.12 standard deviations (SD) around mean estimates, and 2% to 6% for proportions (depending on base rate).
In order to achieve this sample size, we found an attrition rate of 18.75%. Using a more conservative 20%, N=325 will be approached and consented into the trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
325
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26902 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 42960 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 317120 0
Government body
Name [1] 317120 0
Victorian Government Department of Health in partnership with Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 317120 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Australia
Secondary sponsor category [1] 319379 0
None
Name [1] 319379 0
Address [1] 319379 0
Country [1] 319379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315874 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315874 0
Ethics committee country [1] 315874 0
Australia
Date submitted for ethics approval [1] 315874 0
05/08/2024
Approval date [1] 315874 0
02/10/2024
Ethics approval number [1] 315874 0

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

Contacts
Principal investigator
Name 136054 0
Prof Vicki Anderson
Address 136054 0
Murdoch Childrens Research Institute, 50 Flemington Rd, Parkville, VIC, 3052
Country 136054 0
Australia
Phone 136054 0
+61 408347240
Fax 136054 0
Email 136054 0
[email protected]
Contact person for public queries
Name 136055 0
Nick Anderson
Address 136055 0
Murdoch Childrens Research Institute, 50 Flemington Rd, Parkville, VIC, 3052
Country 136055 0
Australia
Phone 136055 0
+61421920612
Fax 136055 0
Email 136055 0
[email protected]
Contact person for scientific queries
Name 136056 0
Nick Anderson
Address 136056 0
Murdoch Childrens Research Institute, 50 Flemington Rd, Parkville, VIC, 3052
Country 136056 0
Australia
Phone 136056 0
+61421920612
Fax 136056 0
Email 136056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices)
When will data be available (start and end dates)?
Available for 5 years after completion of study
Available to whom?
Researchers from MCRI whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI’s conditions for access
Available for what types of analyses?
For secondary analysis of pre-post intervention treatment data.
How or where can data be obtained?
As data will be shared within MCRI, data will be available to access from secure MCRI data severs with permission from the study PI Vicki Anderson ([email protected](


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.