Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001962224
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
5/12/2018
Date last updated
5/12/2018
Date data sharing statement initially provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Early management mild traumatic brain injury
Scientific title
Efficacy of providing early interdisciplinary treatment in mild traumatic brain injury on participation and quality of life
Secondary ID [1] 296767 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMMBIRS (Early Management Mild Brain Injury Rehabilitation Service)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Brain Injury 310656 0
Concussion 310657 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309366 309366 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Uncomplicated Concussion managed in CONCUSSION CLINIC
These clients will have sustained an injury resulting in post concussive injury but with no significant radiological signs and a Post Traumatic Amnesia Score (PTA) of less than 1. Current usual care which includes assessment, provision of information and advice will be provided to these individuals. They will normally be discharged from the clinic within 8 weeks according to reduction or cessation of symptoms.

If significant symptoms remain at 8 weeks they will be referred to the mild TBI Clinic for ongoing management.
2. Complicated Concussion/mildTBI managed in BRAIN INJURY mTBI EARLY REHABILITATION PROGRAM.
EMMBIRS will commence early after injury (on referral) and be offered up to 6 months post-accident. It will have a remedial focus on the treating of participant’s specific symptoms and /or impairments that may be acting as barriers to the person returning to their pre-existing roles and activities.
Intervention will be primarily impairment focused, designed according to each individuals needs and may include
o Management of emotional, cognitive and behavioural issues resulting from frontal lobe or other damage
o Management of subtle memory, cognitive-communication difficulties and activities of daily living
o Vestibular rehabilitation
o Metabolic and physiologic rehabilitation to support physiological recovery from mild TBI.
The delivery of the intervention to the program will include use of technology whenever appropriate. Tele-rehabilitation (including provision of tablets) and use of therapeutic apps (standard and rehabilitation specific) and use of low cost, off the shelf and bespoke rehabilitation software will be trialed and evaluated.
The intervention team will consist of a Rehabilitation Physician or doctor experienced in working with patients following an ABI, Occupational Therapist, Physiotherapist, Social Worker, Speech Pathologist and Psychologist. Patients will be seen 1-4 times a week (in person or via telerehabilitation) depending on need and up to 6 months depending on progression towards reaching their goals. Rehabilitation will be provided according to each patients' individual needs and according to best practice principles. This is a pragmatic trial; however records of all interventions will be kept in terms of type, content and duration.
Telerehabilitation will be accessed by Cisco Jabber for videoconferencing. Therapy apps will be provided according to need and what is available at the time; therapy apps change and are updated frequently and hence so will the type of apps provided. Apps used will be those that are freely available to public but assessed by the therapy team regarding usefulness and according to level of security provided.
Intervention code [1] 313078 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308321 0
Mayo-Portland Adaptability Inventory

Timepoint [1] 308321 0
Baseline, 8 weeks, 16 weeks, 6 months, 12 months, 18 months
Primary outcome [2] 308322 0
Family Outcome Measure.
Timepoint [2] 308322 0
Baseline, 8 weeks, 16 weeks, 6 months, 12 months, 18 months.
Primary outcome [3] 308323 0
Depression Anxiety Stress Scale short form (DASS21).
Timepoint [3] 308323 0
Baseline, 8 weeks, 16 weeks, 6 months, 12 months, 18 months.
Secondary outcome [1] 354608 0
The EuroQol 5 (EQ-5D-5L )
Timepoint [1] 354608 0
Baseline, 8 weeks, 16 weeks, 6 months, 12 months, 18 months.
Secondary outcome [2] 354609 0
Indepth composite information will be collected. Interviews will be offered to participants at the completion of their rehabilitation to gain their perceptions of the program they received and again at 18 months to investigate how they have been able to reintegrate into their previous lifestyle or how successfully they have been able to adapt to any changes. They will be asked their perception of the timing of the intervention, the type of intervention, the way in which the intervention was provided, their recovery journey, long-term sustainability of any improvements and any problems that have caused ongoing issues to their ability to return to their preferred roles and activities.
Timepoint [2] 354609 0
Completion of rehabilitation (up to 6 months) and 18 months

Eligibility
Key inclusion criteria
All participants who have suffered a concussion or mild TBI due to any type of accident while utilising any mode of transport, either on road or off, in registrable or non registrable vehicle.
They will enter mild TBI clinic through one of 2 pathways
1. Directly to the mild TBI Clinic, as they meet the criteria of an abnormality on MRI or CT, or a PTA between 1-7. OR
2. From the Concussion Clinic, if the advice and care offered in that clinic does not resolve ongoing issues at 8 weeks post injury.
They will enter Concussion Clinic if their injury is not serious enough to attend mild TBI clinic. ie no abnormal imaging, PTA less than 1 but have some ongoing issues after incident that are attributable to a concussion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A Concussion or Mild TBI as a result of accident while not utilising any mode of transport.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/12/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12620 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 25038 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 301346 0
Government body
Name [1] 301346 0
Lifetime Support Authority
Country [1] 301346 0
Australia
Primary sponsor type
Hospital
Name
South Australia Brain Injury Rehabilitation Services
Address
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country
Australia
Secondary sponsor category [1] 301013 0
None
Name [1] 301013 0
Address [1] 301013 0
Country [1] 301013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302083 0
Central Adelaide Local Health Network
Ethics committee address [1] 302083 0
CALHN Research Office
Level 3 Roma Mitchell House
136 North Terrace Adelaide SA 5000
Ethics committee country [1] 302083 0
Australia
Date submitted for ethics approval [1] 302083 0
Approval date [1] 302083 0
05/10/2018
Ethics approval number [1] 302083 0
HREC/18/CALHN/365

Summary
Brief summary
Firstly, this project will investigate the number of people in South Australia who experience difficulties after sustaining a concussion/mild traumatic brain injury following a vehicular accident.
In addition, these individuals will be provided assessment and intervention according to best practice guidelines and changes over time will be recorded. In addition, costs for the service will be evaluated and cost drivers determined. This analysis will then let us understand whether the early intervention is effective in preventing long term sequelae, in particular recognising and managing frontal lobe injury syndromes, and evaluating whether the costs incurred are worthwhile.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 89070 0
Dr Maggie Killington
Address 89070 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 89070 0
Australia
Phone 89070 0
+61 8 400061204
Fax 89070 0
Email 89070 0
[email protected]
Contact person for public queries
Name 89071 0
Dr Maggie Killington
Address 89071 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 89071 0
Australia
Phone 89071 0
+61 8 400061204
Fax 89071 0
Email 89071 0
[email protected]
Contact person for scientific queries
Name 89072 0
Dr Maggie Killington
Address 89072 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 89072 0
Australia
Phone 89072 0
+61 8 400061204
Fax 89072 0
Email 89072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Dissemination of data will need to be approved at the time of request by the funding body, LSA.


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.