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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000004460
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The ENhAnCe trial: Evaluating Neuropsychological Assessment to enhance Clinical outcomes for people with brain conditions
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Scientific title
The ENhAnCe trial: Evaluating Neuropsychological Assessment to enhance Clinical outcomes for people with brain conditions
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Secondary ID [1]
312774
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None
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Universal Trial Number (UTN)
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Trial acronym
ENhAnCe trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative disorder
334825
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Psychiatric disorder
334826
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Acquired brain injury
335983
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Mild cognitive impairment
335986
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Condition category
Condition code
Neurological
331384
331384
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0
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Epilepsy
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Mental Health
331382
331382
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0
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Depression
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Neurological
331379
331379
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0
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Neurodegenerative diseases
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Injuries and Accidents
331812
331812
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0
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Other injuries and accidents
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Neurological
331380
331380
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0
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Other neurological disorders
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Mental Health
331383
331383
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0
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Other mental health disorders
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Mental Health
331381
331381
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention Condition: Neuropsychological evaluation
This will involve an individualised comprehensive neuropsychological assessment and invitation to a feedback session, to which family members/support persons may also be invited. The assessments and feedback sessions will be conducted by registered clinical neuropsychologists/clinical neuropsychology registrars employed at the clinical site and provisional psychologists under supervision by registered clinical neuropsychologists.
The neuropsychological assessments will be conducted using a flexible evaluation approach, which involves adjustment of the neuropsychology test battery on the basis of suspected cognitive impairments, differential diagnoses, and the specific referral question. Where clinically indicated all major cognitive domains will be assessed as well as measures of performance validity. Major cognitive domains include attention, memory, language, visuospatial abilities and executive function.
Because this is an intervention that follows a flexible evaluation approach, the length of the neuropsychological assessment can vary from a minimum 90 minutes to a maximum of five hours. Feedback sessions typically last between 30 to 90 minutes. Typically a feedback session would include explanation of the participant's cognitive strengths and weaknesses, formulation of the underlying causes for any cognitive difficulties identified, and strategies and recommendations for how to manage those difficulties. A more detailed account of the typical content in neuropsychological feedback sessions can be found in Longley et al. (2023) and the Psychology Competency Assessment Tool - Feedback checklist (PsyCET-F; Wong et al., 2023), the latter of which will be utilised in this trial to assess intervention fidelity.
To establish adherence to the neuropsychological assessment intervention condition, this will be achieved by attendance at the neuropsychological appointment. The clinician will have needed to complete the Clinician PrONTo outcome measure, which will confirm that this has occurred. Adherence to the brief cognitive screen intervention condition will be established by attendance at the brief cognitive screen (MoCA) appointment and the generation of a score that is sent back to the referrer. Thus, adherence to the intervention will be assessed by attendance at these appointments plus the clinician's ratings on the PsyCET-F for a random subset of participants to ensure competency of delivered feedback.
Family members/support persons are not typically present for the full neuropsychological assessment, nor the brief cognitive screen, however they will be invited to attend the feedback session with the participant's consent.
References:
Longley, W. A., Tate, R. L., & Brown, R. F. (2023). The psychological benefits of neuropsychological assessment feedback as a psycho-educational therapeutic intervention: A randomized-controlled trial with cross-over in multiple sclerosis. Neuropsychological Rehabilitation, 33(5), 764-793.
Wong, D., Pinto, R., Price, S., Watson, L., & McKay, A. (2023). What does competently delivered neuropsychological assessment feedback look like? Development and validation of a competency evaluation tool. The Clinical Neuropsychologist, 38(1), 116-134.
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Intervention code [1]
329303
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Treatment: Other
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Comparator / control treatment
Active Control: Brief cognitive screen
The Montreal Cognitive Assessment (MoCA) is a single-paged test that can be administered in ten minutes and is scored out of 30 points. Cognitive impairment is indicated by a performance that is below the cut-off score of 26, with one-point added to the participant’s score if they have less than 12 years education. No feedback on the results of the MoCA will be provided to the participant/support person. The numerical results of the MoCA will be emailed to the referrer with a brief generic text interpretation of the score.
The brief cognitive screening condition will take the format of an active control, whereby participants allocated to the brief cognitive screening condition will still receive a neuropsychological assessment as part of their standard clinical care after the active phase of the trial. The timeline of the RCT protocol has thus been designed with consideration of the expected waitlist duration at the clinical site, to ensure that participants complete all aspects of the trial prior to reaching the top of the waitlist for neuropsychological assessment (i.e., not hindering their clinical care).
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in the participant/support person’s understanding of how to manage/cope with cognitive symptoms
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Assessment method [1]
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The Proximal Outcomes of Neuropsychology Tool (PrONTo): Pre- and post-versions, and self-report, support person and clinician versions
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Timepoint [1]
340083
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Baseline, two-weeks post intervention, and six-week follow-up.
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Primary outcome [2]
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Change in the participant/support person’s understanding of the participant’s difficulties.
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Assessment method [2]
339736
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The Proximal Outcomes of Neuropsychology Tool (PrONTo): Pre- and post-versions, and self-report, support person and clinician versions
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Timepoint [2]
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [1]
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Carer burden
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Assessment method [1]
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Change in score on the Zarit Burden Interview
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Timepoint [1]
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [2]
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Self-efficacy
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Assessment method [2]
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Change in self-efficacy on the the Memory-Loss Self-Efficacy Scale
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Timepoint [2]
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [3]
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Depression symptomatology
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Assessment method [3]
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Change in score on the short-form of the Depression Anxiety Stress Scale (DASS-21)
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Timepoint [3]
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [4]
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Referrer satisfaction
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Assessment method [4]
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Referrer satisfaction will be evaluated using a brief online survey adapted from Allott et al. (2011) and Temple et al. (2006). Questions will be related to whether the referral question was answered satisfactorily, as well as whether the assessment findings led to changes to the participant’s treatment plan. References Allott, K., Brewer, W., McGorry, P. D., & Proffitt, T. M. (2011). Referrers' perceived utility and outcomes of clinical neuropsychological assessment in an adolescent and young adult public mental health service. Australian Psychologist, 46(1), 15-24. https://doi.org/10.1111/j.1742-9544.2010.00002.x Temple, R. O., Carvalho, J., & Tremont, G. (2006). A national survey of physicians' use of and satisfaction with neuropsychological services. Archives of Clinical Neuropsychology, 21(5), 371-382. https://doi.org/10.1016/j.acn.2006.05.002
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Timepoint [4]
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End of the trial period (i.e., six-week follow-up)
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Secondary outcome [5]
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Acceptability rating
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Assessment method [5]
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Acceptability of the trial components will be rated on a 10-point scale (i.e., 1 = Not at all satisfied, 10 = Extremely satisfied) across two domains: a. Overall Satisfaction (“When thinking about your participation in the study, how satisfied have you been overall?”) b. Recommend to Others (“To what extent would you recommend participating in this study to others?”) Acceptability will be determined by a mean rating of greater than or equal to 80% (i.e., 8/10 or higher).
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Timepoint [5]
441030
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End of the trial period (i.e., six-week follow-up)
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Secondary outcome [6]
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Health-related quality of life
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Assessment method [6]
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Change in score on the WHOQOL-Bref
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Timepoint [6]
441033
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [7]
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Anxiety symptomatology
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Assessment method [7]
442589
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Change in score on the short-form of the Depression Anxiety Stress Scale (DASS-21)
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Timepoint [7]
442589
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Baseline, two-weeks post intervention, and six-week follow-up.
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Secondary outcome [8]
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Stress symptomatology
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Assessment method [8]
442590
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Change in score on the short-form of the Depression Anxiety Stress Scale (DASS-21)
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Timepoint [8]
442590
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Baseline, two-weeks post intervention, and six-week follow-up.
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Eligibility
Key inclusion criteria
Inclusion criteria will be that participants;
i) have been referred to the clinical site for a neuropsychological assessment to assist clinical management or diagnostic clarification,
ii) are able to provide informed consent to participate in research, and
iii) are able to complete the baseline and outcome measures.
One support person of each participant will also be invited to participate if they are willing and available. Inclusion criteria for the support person will be that they:
i) have known the participant for a minimum of 12 months (e.g., family member or paid carer),
ii) are able to provide informed consent to participate in the study,
iii) are aged 18 years or older, and
iv) able to complete the informant baseline and outcome assessment measures administered in English.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will include participants:
i) who do not meet the referral criteria for the Adult General Diagnostic program at the clinical site.
ii) who have been referred for a decision-making capacity assessment,
iii) who have been referred for a joint neuropsychological assessment and speech pathology assessment,
iv) who are unable to provide informed consent for themselves,
v) who require an urgent neuropsychological assessment (e.g., for discharge from an acute setting),
vi) who have severe communication difficulties (e.g., secondary to aphasia) or are not fluent in English, impacting their ability to complete the outcome measures in English,
vii) with acute risk of harm to self and/or others, and
viii) participants who have previously had a neuropsychological assessment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be concealed, whereby the allocation schedule will be generated and retained by an off-site independent researcher and kept hidden from all members of the research team. Each allocation will then be sealed in a consecutively numbered opaque envelope by the independent researcher and the set of envelopes will be given to the enrolling investigator. When the enrolling investigator seeks to enrol and randomise a new participant, the participant’s name will be written on the front of the next available envelope prior to opening the sealed envelope and retrieving the allocation from inside. The enrolling investigator will thus not be aware of the full sequence.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following enrolment and informed consent, individual randomisation to intervention condition will be completed using an online random sequence generator (randomizer.org). Randomisation will be stratified by suspected/established diagnostic group (i.e., neurodegenerative, acquired brain injury, general medicine, and psychiatric ) to ensure diagnostic category is balanced across intervention conditions. Group allocation will be via a covariate-adaptive randomisation to optimise the balance among groups with respect to diagnostic category (suspected or established), following the biased coin randomisation process.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
A sample size of 100 participants (50 in each condition) accords with recommended sample sizes for pilot studies (Eldridge et al., 2016; Sim & Lewis, 2012) and will allow us to robustly estimate the expected effect size parameters for a larger definitive trial.
Pairwise comparisons and linear mixed models will be used to investigate between-group differences at each time point in clinical outcomes. Group allocation will be via a covariate-adaptive randomisation to optimise the balance among groups with respect to diagnostic category (suspected or established), following the biased coin randomisation process. In line with this randomisation method, diagnostic category will be included in the analysis as covariates. Confidence intervals will be reported and the effect size of each intervention condition, defined as the magnitude of change from T1-T3, will be estimated with Cohen’s d based on output from regression models.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/01/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
317707
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Charities/Societies/Foundations
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Name [1]
317707
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Forrest Research Foundation PhD Scholarship
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Address [1]
317707
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Country [1]
317707
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Australia
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Funding source category [2]
317708
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Government body
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Name [2]
317708
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Insurance Commission of Western Australia Neurotrauma Research Program
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Address [2]
317708
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Country [2]
317708
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Australia
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Funding source category [3]
317207
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University
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Name [3]
317207
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Australian Government Research Training Program (RTP) Scholarship
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Address [3]
317207
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Country [3]
317207
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Australia
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Primary sponsor type
University
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Name
The University of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320028
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None
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Name [1]
320028
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Address [1]
320028
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Country [1]
320028
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316402
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
316402
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
316402
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Australia
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Date submitted for ethics approval [1]
316402
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29/05/2024
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Approval date [1]
316402
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01/07/2024
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Ethics approval number [1]
316402
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Ethics committee name [2]
315944
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North Metropolitan Area Mental Health Services Human Research Ethics Committee
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Ethics committee address [2]
315944
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https://www.nmahs.health.wa.gov.au/Research/Ethics/MH--REGO
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Ethics committee country [2]
315944
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Australia
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Date submitted for ethics approval [2]
315944
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28/01/2024
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Approval date [2]
315944
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16/05/2024
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Ethics approval number [2]
315944
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Summary
Brief summary
Cognitive impairments are common for individuals with brain conditions, however adequate assessment and intervention for such cognitive impairments continue to remain an area of high unmet need. In today’s era of resource-limited healthcare, it is becoming increasingly important to determine the value and impact of health services, including neuropsychology, through high quality clinical trial research to facilitate resourcing and allocation of such services. This trial therefore aims to evaluate the value and impact of neuropsychological assessment on improving outcomes for individuals with brain conditions and their families. Specifically, this project aims to evaluate whether comprehensive neuropsychological assessment with feedback, compared with brief cognitive screening with no feedback, results in: a. improved participant and/or support person understanding of the presenting cognitive and behavioural problems, and how to cope with and manage these problems; b. increased referrer satisfaction; c. more changes to clinical management; and/or more improvements to depression/anxiety symptomatology, self-efficacy, health-related quality of life, and carer burden.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Nicole Feast
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Address
136302
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School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
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Country
136302
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Australia
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Phone
136302
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+61 8 6488 1415
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Fax
136302
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Email
136302
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[email protected]
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Contact person for public queries
Name
136303
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Nicole Feast
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Address
136303
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School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
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Country
136303
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Australia
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Phone
136303
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+61 8 6488 1415
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Fax
136303
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Email
136303
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[email protected]
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Contact person for scientific queries
Name
136304
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Nicole Feast
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Address
136304
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School of Psychological Science, The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
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Country
136304
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Australia
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Phone
136304
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+61 8 6488 1415
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Fax
136304
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Email
136304
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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