Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000139279
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
30/01/2018
Date last updated
24/02/2022
Date data sharing statement initially provided
5/02/2020
Date results information initially provided
24/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing rehabilitation services and quality of life for Aboriginal Australians after brain injury: Healing Right Way
Scientific title
Enhancing rehabilitation services and quality of life for Aboriginal Australians after brain injury: Healing Right Way
Secondary ID [1] 293736 0
None
Universal Trial Number (UTN)
U1111-1207-3561
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brain injury 306104 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305232 305232 0 0
Other physical medicine / rehabilitation
Neurological 305354 305354 0 0
Other neurological disorders
Injuries and Accidents 305355 305355 0 0
Other injuries and accidents
Stroke 305356 305356 0 0
Haemorrhagic
Stroke 305357 305357 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of two components:

i) Cultural Security Training for hospital staff surrounding brain injury, including culturally appropriate educational and treatment resources,

The 3 hour face to face education session(s) will be delivered in a workshop format and will be predominately interactive and experiential. These sessions will consist of the sharing and discussion of information regarding the hospital’s local Aboriginal community and protocols, will address unique issues related to the experience of brain injury by Aboriginal people, and will explore authentic clinical situations and strategies to promote culturally secure brain injury care. The workshop will include information sharing; small and large group discussion, video case studies and activities to promote reflective practice. Creating a dialogue between non-Aboriginal health professionals and Aboriginal staff will be a key component of the training in order to model communication and problem solving from a ‘two-way’ perspective. Some content will vary across sites in order to align with local history, customs, language, and relevant cultural practices. The option of delivering the face to face component of the study's cultural security training to participating staff via online platforms has been added to accommodate this possibility under potential general health recommendations during the global pandemic. This component of the training remains group-based.

The three online modules will constitute approximately 3 hours of study and also contain case study material related to Aboriginal brain injury survivors and their family. Participating staff will undertake short quizzes and write personal reflections related to the case studies. They will be provided with relevant readings regarding cultural security in hospital settings in particular and links to relevant websites.

The three hour face to face training element of the cultural security training will be co-facilitated by a local Aboriginal cultural security trainer and a member of the research team. It will be undertaken with 20 staff at each of the study hospital sites. Relevant staff from neurology and neurosurgery/trauma/rehabilitation wards in metropolitan hospitals and general wards in regional hospitals will be nominated by discipline and service heads. A cross section of disciplines (including nursing, medical, and allied health staff) and levels of seniority is required at each site. The training will occur at least once at each site and will be offered every 6 months thereafter to address the issue of changing/rotating staff. Staff will be encouraged to disseminate knowledge gained through the training, and distribute resources as appropriate. The training will be delivered over a maximum period of three weeks at each site. The training will be undertaken to suit the individual site with alternative deliveries being one three hour block or 3 x 1 hour sessions. The face to face sessions must be completed before beginning the online modules.

The online component must be completed within 3-4 weeks of completion of the face to face component. The online modules will be accessed through a secure site based at Edith Cowan University. Staff will log in to the training, and record their name, date of module engagement, and completion of each module.

The face to face training will be group-based. The online training is undertaken individually.

ii) The introduction of an Aboriginal Brain Injury Coordinator (ABIC) at each site. The ABIC will see the participants in hospital and up till 26 weeks post injury, providing education, support, liaison, and advocacy services to the participants and their families.

The ABIC"s role includes:
- Together with hospital staff, supporting the participant/family/carer to source correct information and guidance to make informed decisions which will impact on their access to rehabilitation services and overall wellbeing.
- Providing up to date information, education, support and advocacy to the participants and their carers in the areas of brain injury and rehabilitation.
- Ensuring all activities are aimed at enhancing access to rehabilitation services and promotion of participant wellbeing.
- Facilitating communication between the participant and the hospital team regarding discharge plans and plans for medical and allied health follow-up after discharge. This will be done in collaboration with the medical and allied health teams.
- Facilitating access to rehabilitation services and aiming to improve the health and wellbeing of participants by collaborating with general practitioners, Aboriginal Medical Services, specialists, hospital services, allied health professionals, support agencies and the Neurological Council of Western Australia (Inc.) (NCWA) as well as any other relevant support agencies as appropriate.
- Becoming a clear link between agencies and the participants.
- Monitoring the support needs of the participants following discharge from hospital, including as necessary, referrals and follow up with relevant organisations, endeavouring always to provide continuity of care.

The ABIC will visit each participant within five working days of the completion of the baseline assessment and the visits will continue on a regular basis for 26 weeks post stroke/TBI.

The ABIC will be in contact with the participant and/or a member of their family/carer a minimum of six times across this period, with contact made at least once every four weeks. There is no maximum number of contacts between the ABIC and the participant, with the ABIC providing services in line with variable health and support needs and time available. If it is not possible to visit the person within their home the ABIC will maintain contact with the participant through regular phone calls or video-teleconference facilities. Contacts will be approximately 30 minutes in duration.

An Aboriginal person will be employed for one day/week at each of the project sites as an Aboriginal Brain Injury Coordinator (ABIC). The ABIC will see the participants in hospital and up till 26 weeks post injury onset and provide education, support, liaison, and advocacy services to the participants and their families. A minimum qualification of a Certificate 3 in a relevant health or community care subject of study will be required. Qualifications and experiences as an Enrolled or Registered Nurse or in Aboriginal Health Work will be highly desirable.

The ABIC will receive 12 hours of training from the Neurological Council of Western Australia (NCWA) (a key project partner) and the research team. Each ABIC will be located either in the hospital, the local community controlled Aboriginal Medical Service (AMS), or offices of the NCWA as part of their community neurological nursing service, depending on the preference of each site. This person will be supported by the local AMS, the NCWA community nursing service, and the research project manager.


The original online modules are not offered through the Indigenous HealthInfoNet as originally planned, but are still administered by Edith Cowan University.
Intervention code [1] 299990 0
Rehabilitation
Comparator / control treatment
A stepped wedge cluster randomised control trial (CRCT) design will be used, with individual healthcare sites functioning as clusters. Twenty-six weeks of baseline control data (usual care) will be obtained prior to implementation of the intervention, which will be introduced sequentially to all sites at 26-week intervals. Control data will continue to be collected at each site until the intervention commences. Aboriginal patients recruited to the study after brain injury will receive Usual Care as the control group prior to the intervention being introduced at their site.

In the context of this health service study, ‘usual care’ is defined as the contacts between the participant and the healthcare staff and cultural support services during the acute hospital stay through to 26 weeks post injury. The engagement between the participant’s treating medical, nursing and allied health team at the hospital and the participant’s family and community health and support services constitute usual care. Usual care will vary across sites due to variation in local service delivery models. Usual care will be mapped through a file audit process Each hospital context for usual care will be mapped as part of the process evaluation component of the trial .
Control group
Active

Outcomes
Primary outcome [1] 304387 0
Quality of Life. To be assessed using the Euro QOL–5D-3L VAS.
Timepoint [1] 304387 0
The Week 26 follow-up time frame was extended to 26 weeks post injury (+28 days).
Secondary outcome [1] 341786 0
Service delivery (rehabilitation related occasions of service). To be measured through file audit.
Timepoint [1] 341786 0
12 and 26 weeks post brain injury
Secondary outcome [2] 341787 0
Service delivery (the hospital’s compliance with minimum process of care indicators). To be assessed through file audit.
Timepoint [2] 341787 0
12 and 26 weeks post brain injury
Secondary outcome [3] 341788 0
Level of disability. To be assessed using the Modified Rankin Scale – mRS.
Timepoint [3] 341788 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [4] 341789 0
Carer burden. To be assessed using the Modified Caregiver Strain Index.
Timepoint [4] 341789 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [5] 341790 0
Brain injury survivor anxiety. To be assessed by the Hospital Anxiety and Depression Scale.
Timepoint [5] 341790 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [6] 342194 0
Brain injury survivor depression. To be assessed by the Hospital Anxiety and Depression Scale.
Timepoint [6] 342194 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [7] 342195 0
Cost-effectiveness of the intervention. To be determined by measuring the incremental costs and benefits of the intervention (i.e. Quality Adjusted Life Years [QALYs] gained derived from EQ5D results) compared to control and expressed as a ratio by dividing by the net benefits for the outcomes of interest.
Timepoint [7] 342195 0
26 weeks post injury.
Secondary outcome [8] 342196 0
Acceptability of the Cultural Security Training to health professionals. To be assessed through an online questionnaire designed specifically for this study.
Timepoint [8] 342196 0
At completion of Cultural Security Training.
Secondary outcome [9] 342197 0
Acceptability of hospital care to Aboriginal participants. To be assessed through a questionnaire designed specifically for this study and administered by the trial assessor.
Timepoint [9] 342197 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [10] 342198 0
Acceptability of the Aboriginal Brain Injury Coordinator service to Aboriginal participants in relation to the Aboriginal Brain Injury Coordinator role and Aboriginal participants and their families. To be assessed through a questionnaire designed specifically for this study and administered by the trial assessor.
Timepoint [10] 342198 0
The Week 12 follow-up time frame was extended to 26 weeks post injury (+/- 14 days).

The Week 26 follow-up time frame was extended to 26 weeks (+28/-14 days).
Secondary outcome [11] 342199 0
Feasibility of the Aboriginal Brain Injury Coordinator role. To be assessed through the percentage of participants for whom the ABIC was able to undertake the role activities as per protocol.
Timepoint [11] 342199 0
26 weeks.
Secondary outcome [12] 406784 0
Level of independence. To be assessed using the Functional Independence Measure - FIM
Timepoint [12] 406784 0
The FIM will be administered at 12 weeks post injury (+/- 14 days) and at 26 weeks post injury (+28 days)

Eligibility
Key inclusion criteria
• Identification as Aboriginal (from medical file or through self-identification via personal communication with staff)
• 18 years or older
• Acute ischaemic or haemorrhagic stroke defined as “an acute episode of focal dysfunction of the brain lasting longer than 24 hours, or of any duration if imaging (CT or MRI) shows focal infarction or haemorrhage relevant to the symptoms”
• Acute traumatic brain injury defined as 1) a head trauma severe enough to cause traumatic brain injury and causing neurological symptoms (including headache and nausea) lasting at least 1 week and 2) at least one of the following: loss of consciousness for at least 1 minute, posttraumatic amnesia for at least 30 minutes, neurological symptoms (excluding headache and nausea) during the first 3 days after the injury, or neuroradiological findings suggesting traumatic brain injury (e.g., skull fracture, intracerebral haemorrhage)
• Neurological deficit present as reflected in NIHSS34 > 0
• Able to benefit from rehabilitation as determined by the medical and allied health team within the first four weeks post injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• TIA (defined as “focal dysfunction of less than 24 hours duration and with no imaging evidence of infarction” )
• Glasgow Coma Scale (GCS)35 severity score <8
• Concurrent progressive neurological disorder(s)
• Pre-existing clinical diagnosis of dementia with patient fulfilling ICD 10 criteria for dementia
• Documented pre-existing psychosis
• For palliative care and not likely to survive to primary endpoint i.e. 26 weeks
• Participation in other intervention trial

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All clusters will be identified and recruited to the study prior to randomisation. Each cluster will be allocated a number and randomised by computer by the trial statistician who will be unaware of the identity/location of the clusters involved. In order to plan the roll-out of the intervention across clusters in the stepped wedge design, the local principal investigators will be advised (just prior to the initial baseline control period) of which year the intervention will be introduced at their site. Specific times will be advised six months prior to the intervention commencing in order to assist with site organisation. Baseline assessors who recruit individual participants to the trial may be aware of the allocation in smaller regional sites where concealment may not be possible due to the nature of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be assigned to a particular intervention commencement time through the use of computer-generated sequence of random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The study design is a stepped wedge cluster randomised control trial (CRCT) design with individual healthcare sites functioning as clusters. Twenty-six weeks of baseline control data will be obtained prior to implementation of the intervention, which will be introduced sequentially to all sites at 26-week intervals. Control data will continue to be collected at each site until the intervention commences. The intervention will continue within each cluster until the last clusters have received the intervention for a 52 week period. Participants in the cluster control periods will not receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was estimated using GPower 3.1, and adjusted for the design effect of the stepped-wedge design using the method described in Woertman et al. Based on the literature, the mean difference between stroke and non-stroke populations on the Euro QOL–5D VAS is approximately 25 points with a standard deviation of 25. We anticipate that the intervention will result in an improvement of 15 points on the Euro QOL–5D VAS (with a standard deviation 25). This equates to a medium-large effect size of d=0.6. GPower estimated that we would require a total of 90 participants to detect this difference with 80% power at the 5% significance level. To adjust for the design effect, we assumed a conservative intraclass correlation of 0.08. After adjusting for the design effect for a 4-step stepped-wedge design with one baseline measurement and one follow-up measurement, we estimate that we will need to recruit 13 patients at each site in every time period. This equates to a total sample size of 312 patients.

The primary analysis will be performed on an intention to treat basis with each participant allocated to the site at which he/she was originally recruited.
Primary outcome analysis
The primary hypothesis (H1) will be analysed using a mixed effects linear regression model, which controls for the effects of secular trends over time. The model will be designed to assess the effect of the intervention on Euro QOL–5D-3L VAS score at 26 weeks post injury. Differences in baseline characteristics will be included in the model.

Secondary outcomes analyses
A mixed effects logistic regression model will be used to assess the impact of the intervention on the odds of achievement of the minimum processes of care [H2a]. The outcome variable will be a binary variable: minimum processes of care received by patient in the first 26 weeks post brain injury versus minimum processes of care not received by patient in the first 26 weeks post brain injury. Time will be included as a fixed effect in the model to control for the effects of secular trends. Site will be included as a random effect in the model.
A linear mixed effects regression model will be used to assess the impact of the intervention on the occasions of service [H2b]. The outcome variable will be the count of the occasions of service in the first six months post brain injury. Type and severity of the brain injury will be controlled for in the model. Time will be included as a fixed effect in the model to control for the effects of secular trends. Site will be included as a random effect in the model.
To examine the secondary outcomes of effects of the intervention on stroke/TBI disability and independence after injury [H3], the mRS score will be dichotomised into good outcome (mRS 0-2) and poor outcome (mRS 3-6). A logistic generalized linear mixed model will be developed to assess the impact of the intervention on mRS at baseline, 12 and 26 weeks after injury. Within-cluster effects will be controlled for in the model and deviations from the protocol caused by changes in care site will be included as random effects.
A longitudinal linear mixed model will be used to assess the impact of the intervention on carer burden [H4]. The outcome variable will be the Modified Caregiver Strain Index at 12 and 26 weeks post brain injury. Type and severity of the brain injury will be controlled for in the model. Time period will be included as a fixed effect in the model to control for the effects of secular trends. Site will be included as a random effect in the model.
A longitudinal linear mixed model will be used to assess the impact of the intervention on anxiety and depression [H4]. The outcome variable will be the Hospital Anxiety and Depression Scale at 12 and 26 weeks post brain injury. Type and severity of the brain injury will be controlled for in the model. Time period will be included as a fixed effect in the model to control for the effects of secular trends. Site will be included as a random effect in the model.
1. Safety
Adverse events are expected to have a Poisson or negative binomial distribution. The distribution will be examined and the appropriate regression models will be used to compare counts of serious adverse events between conditions. Logistic regression will be used to compare binary adverse events (e.g. death). Risk ratios will be adjusted as per primary analysis with age, and mRS included as covariates.
2. Demographics
Baseline demographic characteristics will be tabulated. Between condition differences in continuous/ordinal measures will be assessed using one-way ANOVA or the Kruskal-Wallis test. Chi-square tests will be used to assess differences in categorical variables.
3. Blinding
All assessors will be independent of the researchers involved in the intervention or the trial. However, because of the study design involving site allocation to the intervention, baseline assessors in rural areas will most likely be aware of whether their local hospital is in intervention or control phase. Hence it may not be possible to blind these assessors, patients or most investigators on whether the patients received intervention or not. However, follow-up assessors will be blinded to the baseline assessment of any given participant and to the intervention allocation. All analyses will be carried out by a statistician who is blinded to the randomization of sites and allocation of individual patients to intervention or control. Assessor blinding will be examined according to CONSORT guidelines at 12 weeks. The James blinding index will be used to assess the effectiveness of the blinding.
4. Post hoc analyses
The relationship between amount of services received, baseline stroke and traumatic brain injury severity and recovery are likely to be part of post hoc analyses given their clinical relevance.
5. Interim analyses
The DSMC will review interim data for adverse events and serious adverse events. The DSMC will use the Haybittle-Peto boundary with a difference of at least 3 standard errors in the analysis of serious adverse events (e.g. death from all causes, aspiration pneumonia within the first 50 days post injury) needed to justify halting, or modifying the study before the planned completed recruitment. There will be no interim analyses for efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2018
Actual
7/02/2018
Date of last participant enrolment
Anticipated
31/01/2021
Actual
31/07/2021
Date of last data collection
Anticipated
31/07/2021
Actual
31/01/2022
Sample size
Target
312
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9704 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 9705 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 9706 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 9711 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [5] 9712 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [6] 9713 0
Broome Hospital - Broome
Recruitment hospital [7] 9714 0
Kalgoorlie Hospital - Kalgoorlie
Recruitment hospital [8] 9715 0
Geraldton Hospital - Geraldton
Recruitment hospital [9] 9760 0
Hedland Health Campus - South Hedland
Recruitment postcode(s) [1] 18474 0
6000 - Perth
Recruitment postcode(s) [2] 18475 0
6009 - Nedlands
Recruitment postcode(s) [3] 18476 0
6150 - Murdoch
Recruitment postcode(s) [4] 18482 0
6160 - Fremantle
Recruitment postcode(s) [5] 18483 0
6056 - Midland
Recruitment postcode(s) [6] 18484 0
6725 - Broome
Recruitment postcode(s) [7] 18485 0
6430 - Kalgoorlie
Recruitment postcode(s) [8] 18486 0
6530 - Geraldton
Recruitment postcode(s) [9] 18538 0
6722 - South Hedland

Funding & Sponsors
Funding source category [1] 298350 0
Government body
Name [1] 298350 0
National Health and Medical Research Council
Country [1] 298350 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup. Western Australia. 6027.
Country
Australia
Secondary sponsor category [1] 297472 0
None
Name [1] 297472 0
Address [1] 297472 0
Country [1] 297472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299345 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 299345 0
Level 5, Colonial House
Royal Perth Hospital
Wellington Street, PERTH WA 6000
Ethics committee country [1] 299345 0
Australia
Date submitted for ethics approval [1] 299345 0
17/05/2017
Approval date [1] 299345 0
05/09/2017
Ethics approval number [1] 299345 0
RGS0000000125
Ethics committee name [2] 299355 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 299355 0
450 Beaufort Street
Highgate
Western Australia 6003
Ethics committee country [2] 299355 0
Australia
Date submitted for ethics approval [2] 299355 0
17/05/2017
Approval date [2] 299355 0
28/06/2017
Ethics approval number [2] 299355 0
WAAHEC HREC Project Reference: 794
Ethics committee name [3] 299356 0
St John of God Healthcare Human Research Ethics Committee
Ethics committee address [3] 299356 0
Suite 304, 25 McCourt St
Subiaco
Western Australia 6008
Ethics committee country [3] 299356 0
Australia
Date submitted for ethics approval [3] 299356 0
05/07/2017
Approval date [3] 299356 0
14/07/2017
Ethics approval number [3] 299356 0
Ref 1198
Ethics committee name [4] 299357 0
Edith Cowan Human Research Ethics Committee
Ethics committee address [4] 299357 0
270 Joondalup Drive
Joondalup
Western Australia 6027
Ethics committee country [4] 299357 0
Australia
Date submitted for ethics approval [4] 299357 0
12/09/2017
Approval date [4] 299357 0
15/09/2017
Ethics approval number [4] 299357 0
17291

Summary
Brief summary
This project involves implementation of the first culturally secure intervention package for Aboriginal survivors of brain impairment in Australia. Aboriginal Australians experience stroke up to three times more frequently than non-Aboriginal Australians, with traumatic brain injury due to assault occurring up to 21 times more often. Yet Aboriginal people remain under-represented in rehabilitation programs. The proposed project follows on from the team's Missing Voices study (NHMRC ID#1046228) that investigated the extent and impact of communication disorders after brain injury in Aboriginal people across Western Australia. Findings suggested significant changes in service delivery are warranted and wanted by Aboriginal brain injury survivors, their families and health service providers. The project aims to improve accessibility to rehabilitation services for all Aboriginal people post brain injury in Western Australia, improve health outcomes for this
population, and establish an economic model for the above which will contribute to sustainability and planning of future services. Utilising a stepped wedge cluster randomised control design, the study will involve a complex intervention consisting of a) cultural security training for hospital staff tailored to the delivery of services to Aboriginal people with brain injury, b) use of culturally appropriate educational materials, and c) introduction of a specialist Aboriginal Brain Injury Coordinator to provide an in-reach service to participating hospitals as well as coordination of care and advocacy after hospital discharge. The service and costing models developed in the project will provide a basis for future planning of brain injury services as well as services for a variety of other conditions in WA and nationally.
Trial website
Trial related presentations / publications
Armstrong, E., Coffin, J., Hersh, D., Katzenellenbogen, J. M, Thompson, S. C., Ciccone, N., Flicker, L., Woods, D., Hayward, C., & McAllister, M. (2019). Aboriginal Australian experiences of brain injury and ways forward in culturally secure rehabilitation. Australasian Society for the Study of Brain Impairment/New Zealand Rehabilitation Association Inaugural Trans-Tasman Conference, Wellington, NZ, May.

Armstrong, E., Coffin, J., Hersh, D., Ciccone, N., Mcallister, M., Katzenellenbogen, J., Thompson, S., Flicker, L., Rai, T., Cadilhac, D., Godecke, E., Drew, N., Hanke, G., Hayward, C., Woods, D. & Lin, I. (2018). Healing Right Way: An RCT designed to improve quality of life of Aboriginal Australians after brain injury. Paper presented at Aphasiology Symposium of Australasia, Sunshine Coast, November.

Armstrong, E., Hersh, D., Ciccone, N., McAllister, M., Katzenellenbogen, J., Thompson, S., Flicker, L., Coffin, J., Rai, T., Cadilhac, D., Godecke, E., Drew, N., Hanke, G., Hayward, C., Woods, D. & Lin, I. (2018). Healing Right Way: Progress to date on an RCT involving Aboriginal Australians after acquired brain injury. Paper presented at the Stroke Society of Australasia Conference, Sydney, August.

Armstrong, E., Hersh, D., Katzenellenbogen, J., Thompson, S., Ciccone, N., Flicker, L., Coffin, J., Rai, T., Cadilhac, D., Godecke, E., Hayward, C., Woods, D., Hankey, G., Lin, I., Drew, N. & McAllister, M. (2018). Enhancing rehabilitation services for Aboriginal Australians after brain injury. Speech Pathology Australia Conference, May, Adelaide.

Armstrong, E., Hersh, D., Ciccone, N., McAllister, M., Katzenellenbogen, K., Thompson, S., Coffin, J., Flicker, L., Hayward, C., & Woods, D. (2017). Stories informing services for Aboriginal Australians after brain injury. NHMRC/Lowitja Translation Symposium, November, Brisbane.

Armstrong, E., Hersh, D., Katzenellenbogen, J., Thompson, S., Ciccone, N., Flicker, L., Coffin, J., Rai, T., Cadilhac, D., & Godecke, E. (2017). Enhancing rehabilitation services for Aboriginal Australians after brain injury. Presentation at Stroke Society of Australasia Rehabilitation Workshop, Stroke Society of Australasia 27th Annual Scientific Meeting, Queenstown, New Zealand, August.
Public notes
Attachments [1] 2365 2365 0 0
/AnzctrAttachments/374267-170906_Royal Perth Hospital Human Research Ethics Committee (EC00270)_Ethics Approved - HREC.pdf (Ethics approval)
Attachments [2] 2367 2367 0 0
/AnzctrAttachments/374267-WAAHEC HREC 794 Approval Letter.pdf (Ethics approval)
Attachments [3] 2368 2368 0 0
/AnzctrAttachments/374267-SJOG#1198 Ethical Approval 14Jul2017.pdf (Ethics approval)
Attachments [4] 2369 2369 0 0
/AnzctrAttachments/374267-Master Participant PICF Version 3_clean_09112017.doc (Participant information/consent)
Attachments [5] 2370 2370 0 0
/AnzctrAttachments/374267-Master Participant Assent Version 2_clean_09112017.doc (Participant information/consent)
Attachments [6] 2371 2371 0 0
/AnzctrAttachments/374267-Master Person responsible PICF Version 4_clean_version_09112017.doc (Participant information/consent)
Attachments [7] 2372 2372 0 0
/AnzctrAttachments/374267-Master Next of Kin PICF Version 3_clean_ 09112017.doc (Participant information/consent)
Attachments [8] 2373 2373 0 0
/AnzctrAttachments/374267-Master Cultural Security Training PICF Version 3_clean_09112017.docx (Participant information/consent)
Attachments [9] 2374 2374 0 0
/AnzctrAttachments/374267-Master ABIC PICF Version 4_clean version_09112017.doc (Participant information/consent)
Attachments [10] 2375 2375 0 0
/AnzctrAttachments/374267-ECU_17291 Multicentre Approval_September 2017.pdf (Ethics approval)

Contacts
Principal investigator
Name 80126 0
Prof Elizabeth Armstrong
Address 80126 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 80126 0
Australia
Phone 80126 0
+61 8 6304 2769
Fax 80126 0
Email 80126 0
[email protected]
Contact person for public queries
Name 80127 0
Ms Meaghan McAllister
Address 80127 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 80127 0
Australia
Phone 80127 0
+61 8 6304 5468
Fax 80127 0
Email 80127 0
[email protected]
Contact person for scientific queries
Name 80128 0
Prof Elizabeth Armstrong
Address 80128 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country 80128 0
Australia
Phone 80128 0
+61 8 6304 2769
Fax 80128 0
Email 80128 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 have no ethical approval for data sharing at this point.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6784Study protocol    374267-(Uploaded-05-02-2021-13-21-14)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a prospective process evaluation of a culturally secure rehabilitation programme for Aboriginal Australians after brain injury: The Healing Right Way project.2021https://dx.doi.org/10.1136/bmjopen-2020-046042
EmbaseHealing Right Way: Study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury.2021https://dx.doi.org/10.1136/bmjopen-2020-045898
Dimensions AIStatistical analysis plan for the stepped wedge clinical trial Healing Right Way—enhancing rehabilitation services for Aboriginal Australians after brain injury2022https://doi.org/10.1186/s13063-022-06800-0
N.B. These documents automatically identified may not have been verified by the study sponsor.