Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001126202
Ethics application status
Approved
Date submitted
19/06/2018
Date registered
10/07/2018
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Computerised Cognitive Training as an intervention for participants with Mild Cognitive Impairment with Sleep Disturbance
Scientific title
Investigating the effect of Computerised Cognitive Training on global cognition in participants with MCI with Sleep Disturbance
Secondary ID [1] 295246 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment (MCI) 308413 0
Sleep disturbance 308414 0
Condition category
Condition code
Neurological 307403 307403 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computerise Cognitive Training (CCT) is a cognitive intervention that uses computerised platforms including audiovisual stimuli, videogames or virtual reality. It involves repeated exercises on one or multiple cognitive domains such memory, executive functions or processing speed. The advantages of using this intervention is that it is safe, scalable, versatile, adaptive, and relatively inexpensive.

The intervention will utilise the NHMRC-funded Maintain Your Brain Trial’s “Brain Training System (BTS)”, designed by CI Valenzuela that implements exercises from NeuroNation. BTS CCT involves online, guided, drill-and-practice standardised tests that load on specific cognitive processes. These cognitively challenging tasks usually are conducted without explicit instruction of problem-solving strategies. The exercises target either working memory, logic, attention and verbal skills or a combination. Examples of these exercises include memorising shopping lists and selecting items from shelves (verbal memory), clicking a button when a circular object skips a point in a circle (attention), figuring out which of 3 choices is a rotated version of an object as quick as possible (logic).

The BTS system is a personalised cognitive training program run as flash files meaning that the training regime is based on the participants’ baseline cognitive profile and continues to evolve in response to within-training task performance. Performance across verbal executive, speed, verbal memory, visual executive, visual memory and visual attention are ranked in descending order. The training session will ‘sandwich’ the weaker cognitive abilities in the middle of the training session with the participants stronger cognitive task at the beginning and end of the session. Task difficulty and task type will be recalculated throughout the training depending on the participants’ improvement. BTS is therefore designed to be automatically adaptive to a participant’s baseline score and progress during training.

Participants will complete supervised, centre-based BTS CCT twice a week, between 45 mins to one hour sessions, for a total of twelve weeks (24 sessions). This will be conducted in a computer room within the Brain and Mind Centre individually, with supervision from a 'trainer'. If participants have access to a home computer and internet it will be optional for participants to complete one session per week from home after completing successfully 6 supervised sessions. They will be shown and allowed to practice accessing the intervention as if they were at home. Each session is roughly 45 minutes long and will comprise of 17 exercises.

Subjects will be randomly allocated in a 1:1 ratio to either 3-months of supervised, centre-based, multidomain CCT (ARM A) or wait-list control (ARM B). After 3-months the wait list control will undergo the same intervention as Arm A
Intervention code [1] 301582 0
Treatment: Other
Comparator / control treatment
Wait list control (Arm B) will comprise of no treatment as is standard care. Currently there is no treatment for MCI. Standard practice within the referral clinics is an initial assessment and feedback of results. The wait-list control group receive this non-treatment for the same time as the treatment (i.e. 3 months). Whilst the waitlist control are receiving treatment Arm A receive no treatment
Control group
Active

Outcomes
Primary outcome [1] 306375 0
To assess the effect of CCT versus waiting list control on global cognition in multi-domain MCI with sleep disturbance.

Global Cognition as defined by pre-specified average of z-scores (referenced to baseline) across following weighted cognitive domains:
1. Memory (40%): Wechsler Adult Intelligence Scale (WAIS) Digit Span(1); LOGOS; Wechsler Memory Scale-III Logical Memory I and II ( 2,3,4), Rey Complex Figure Test-3 minute Recall(5).
2.Speed of processing (15%): Trails Making A(6).
3. Language (15%): Controlled Oral Word Association Test(7)
4. Visuospatial skills (15%): Rey Complex Figure Test-Copy(5)
5.Executive functioning (15%): Trails Making B(6)

1. Wechsler, D.A. Digit Span. in Wechsler Adult Intelligence Scale (The Psychological Corporation, San Antonio, TX, 1997).
2. Schmidt, M. Rey Auditory Verbal Learning Test: A handbook, (Western Psychological Services, Los Angeles, CA, 1996).
3. Wechsler, D.A. Logical Memory I. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
4. Wechsler, D.A. Logical Memory II. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
5. Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
6. Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
7. Ivnik, R.J., Malec, J.F., Smith, G.E., Tangalos, E.G. & Petersen, R.C. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE token, WRAT-R reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist 10, 262-278 (1996).
Timepoint [1] 306375 0
As the Primary outcome is in relation to the baseline it will be measured at baseline and at 3 months after Arm-A's intervention commencement (primary end point).
Secondary outcome [1] 348284 0
To investigate if the therapeutic cognitive effect differs if training commenced immediately or 3-months late.

This is assessed by comparing the effectiveness (change from baseline) of CCT training in Arm A (immediate intervention) to Arm B (waitlist controls) 3 months after the intervention by comparing change on the primary outcomes (i.e. Global cognition made up of the following; Memory (40%): Wechsler Adult Intelligence Scale (WAIS) Digit Span(1); LOGOS; Wechsler Memory Scale-III Logical Memory I and II ( 2,3,4), Rey Complex Figure Test-3 minute Recall(5); Speed of processing (15%): Trails Making A(6); Language (15%): Controlled Oral Word Association Test(7); Visuospatial skills (15%): Rey Complex Figure Test-Copy(5) and Executive functioning (15%): Trails Making B(6)).

1. Wechsler, D.A. Digit Span. in Wechsler Adult Intelligence Scale (The Psychological Corporation, San Antonio, TX, 1997).
2. Schmidt, M. Rey Auditory Verbal Learning Test: A handbook, (Western Psychological Services, Los Angeles, CA, 1996).
3. Wechsler, D.A. Logical Memory I. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
4. Wechsler, D.A. Logical Memory II. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
5. Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
6. Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
7. Ivnik, R.J., Malec, J.F., Smith, G.E., Tangalos, E.G. & Petersen, R.C. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE token, WRAT-R reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist 10, 262-278 (1996).
Timepoint [1] 348284 0
3 months after the intervention is commenced (3 months after the study start/baseline for Arm-A and 6 months after study start/baseline for Arm-B).
Secondary outcome [2] 348435 0
To investigate if the cognitive state 9-months after entering the trial differs if CCT was commenced immediately or 3-months later.

This is assessed by comparing the effectiveness (change from baseline on global cognition- see below) of CCT training on the primary outcome in Arm A (immediate intervention) to Arm B (waitlist controls) 9 months after the commencement of the first intervention

1. Memory (40%): Wechsler Adult Intelligence Scale (WAIS) Digit Span(1); LOGOS; Wechsler Memory Scale-III Logical Memory I and II ( 2,3,4), Rey Complex Figure Test-3 minute Recall(5).
2.Speed of processing (15%): Trails Making A(6).
3. Language (15%): Controlled Oral Word Association Test(7)
4. Visuospatial skills (15%): Rey Complex Figure Test-Copy(5)
5.Executive functioning (15%): Trails Making B(6)

1. Wechsler, D.A. Digit Span. in Wechsler Adult Intelligence Scale (The Psychological Corporation, San Antonio, TX, 1997).
2. Schmidt, M. Rey Auditory Verbal Learning Test: A handbook, (Western Psychological Services, Los Angeles, CA, 1996).
3. Wechsler, D.A. Logical Memory I. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
4. Wechsler, D.A. Logical Memory II. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
5. Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
6. Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
7. Ivnik, R.J., Malec, J.F., Smith, G.E., Tangalos, E.G. & Petersen, R.C. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE token, WRAT-R reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist 10, 262-278 (1996).
Timepoint [2] 348435 0
9 months post study-start/ baseline (9 months after intervention commencement for Arm-A and 6 months after intervention commencement for Arm-B)
Secondary outcome [3] 348437 0
To investigate the change in individuals Memory as measure by the change from baseline on the composite of the Wechsler Adult Intelligence Scale (WAIS) Digit Span(1), LOGOS, the Wechsler Memory Scale-III Logical Memory I and II ( 2,3,4) and the Rey Complex Figure Test-3 minute Recall(5). The difference in an individuals Memory change depending on whether they received immediate or delayed intervention will be investigated by comparing the above measures between Arm A and Arm B

1. Wechsler, D.A. Digit Span. in Wechsler Adult Intelligence Scale (The Psychological Corporation, San Antonio, TX, 1997).
2. Schmidt, M. Rey Auditory Verbal Learning Test: A handbook, (Western Psychological Services, Los Angeles, CA, 1996).
3. Wechsler, D.A. Logical Memory I. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
4. Wechsler, D.A. Logical Memory II. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
5. Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
Timepoint [3] 348437 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [4] 348438 0
To investigate the change in individuals Speed of processing as measure by the change from baseline on the Trails Making A(1). The difference in an individuals Speed of processing change depending on whether they received immediate or delayed intervention will be investigated by comparing the above measures between Arm A and Arm B

1.Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
Timepoint [4] 348438 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [5] 348439 0
To investigate the change in individuals Language as measure by the change from baseline on the Controlled Oral Word Association Test(1). The difference in an individuals Language change depending on whether they received immediate or delayed intervention will be investigated by comparing the above measures between Arm A and Arm B

1.Ivnik, R.J., Malec, J.F., Smith, G.E., Tangalos, E.G. & Petersen, R.C. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE token, WRAT-R reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist 10, 262-278 (1996).
Timepoint [5] 348439 0
3, 6 and 9months post-baseline (only Arm A 9 months post-baseline)
Secondary outcome [6] 348440 0
To investigate the change in individuals Visuospatial skills as measure by the change from baseline on the Rey Complex Figure Test-Copy(1). The difference in an individuals Visuospatial skills change depending on whether they received immediate or delayed intervention will be investigated by comparing the above measures between Arm A and Arm B

1.Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
Timepoint [6] 348440 0
3, 6 and 9 months post-baseline ( only 9 months post-baseline for Arm-A)
Secondary outcome [7] 348441 0
To investigate the change in individuals Executive functioning as measure by the change from baseline on the Trails Making B(1). The difference in an individuals Executive functioning change depending on whether they received immediate or delayed intervention will be investigated by comparing the above measures between Arm A and Arm B


1.Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
Timepoint [7] 348441 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [8] 348442 0
Change (compared to baseline) in daily functional: Amsterdam IADL
Timepoint [8] 348442 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [9] 348443 0
Change (compared to baseline) in quality of life: WHOQOL
Timepoint [9] 348443 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [10] 348776 0
Change (compared to baseline) in mood and mental-health symptoms: 15-Item GDS
Timepoint [10] 348776 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [11] 348777 0
Change (compared to baseline) in sleep-wake patterns: Sleep diary, actigraphy, PSQI
Timepoint [11] 348777 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)
Secondary outcome [12] 348779 0
Change (compared to baseline) in risk-perception: Economic Decision Making Competency tool
Timepoint [12] 348779 0
3, months post-baseline.
Secondary outcome [13] 348780 0
Predictors of cognitive response (change in global cognition) to CCT in relation to APOE 3/4 and BDNF ValMet polymorphism and baseline cognitive profile.

Comparing the effects of of CCT throughout the study depending on gene group.

Global Cognition as defined by pre-specified average of z-scores (referenced to baseline) across following weighted cognitive domains:
1. Memory (40%): Wechsler Adult Intelligence Scale (WAIS) Digit Span(1); LOGOS; Wechsler Memory Scale-III Logical Memory I and II ( 2,3,4), Rey Complex Figure Test-3 minute Recall(5).
2.Speed of processing (15%): Trails Making A(6).
3. Language (15%): Controlled Oral Word Association Test(7)
4. Visuospatial skills (15%): Rey Complex Figure Test-Copy(5)
5.Executive functioning (15%): Trails Making B(6)

1. Wechsler, D.A. Digit Span. in Wechsler Adult Intelligence Scale (The Psychological Corporation, San Antonio, TX, 1997).
2. Schmidt, M. Rey Auditory Verbal Learning Test: A handbook, (Western Psychological Services, Los Angeles, CA, 1996).
3. Wechsler, D.A. Logical Memory I. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
4. Wechsler, D.A. Logical Memory II. in Wechsler Memory Scale-III (The Psychological Corporation, San Antonio, TX, 1997).
5. Meyers, J., & Meyers, K. . Rey Complex Figure and Recognition Trial: Professional manual., (Psychological Assessment Resources, Odessa, FL, 1995).
6. Tombaugh, T.N., Rees, L. & McIntyre, N. Normative data for the Trail Making Test. Personal communication cited in Spreen and Strauss. in A compendium of neuropsychological tests: Administration, norms and commentary (Oxford University Press, New York, 1998).
7. Ivnik, R.J., Malec, J.F., Smith, G.E., Tangalos, E.G. & Petersen, R.C. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE token, WRAT-R reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist 10, 262-278 (1996).
Timepoint [13] 348780 0
3, 6 and 9 months post-baseline (only 9 months post-baseline for Arm-A)

Eligibility
Key inclusion criteria
• Multi-domain amnestic MCI with sleep disturbance
• Amnestic features defined by impairment in recall tasks.
• Other cognitive domains impairment on representative neuropsychological tests
• Sleep disturbance as measured by the Pittsburgh Sleep Quality Index (PSQI) 20 score of > 5
• If using Hypnotics, sedating antihistamines, antipsychotics etc for sleep medication, use must be stable for 3-months (any changes in sleep medication will be monitored during intervention and followup)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of dementia of any aetiology
• History of stroke in last 12 months
• Major neurological disorder requiring current treatment (e.g. epilepsy, Parkinson’s disease)
• Major psychiatric disorder requiring current treatment (e.g. schizophrenia, bipolar disorder)
• Current major depression as measured by the 15-item Geriatric Depression Scale (score of > 10) or the 17-item Hamilton Rating Scale for Depression (score of > 12)
• Physical (sensory or motor) impairment that would restrain training
• Current alcohol dependence or abuse
• Currently undertaking external computerised cognitive training and unwilling to cease during trial engagement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is powered on the basis of a relative effect size (RES) on Global Cognition of 0.44 at the end of the Phase I RCT (based on average from our Timecourse (2) Trial and NHMRC SMART trial (3)). Designate power of 0.80 controlling alpha at 0.05 translates to a required sample size of N=52 (calculated using G*Power 3.1 based on ANOVA repeated measures within-between interaction test, 2 groups, 2 time-points, within subject autocorrelation =0.4, equivalent effect size of [v]=0.22). A sample of N=62 (rounded up from 61) will be recruited to allow for 15% overall attrition (as per Timecourse Trial extrapolated to 9-months).

Statistical Analysis Plan
Phase I: An intention-to-treat approach using recommended Linear Mixed Modelling (1) will evaluate a model including main effects for Group (Arm A vs Arm B), Time (BaseLine[BL] vs Follow-up 1 [FU1]) and the main interaction term of interest: Group X Time. Covariates will only be added if baseline differences are noted between groups.

Phase II Linear Mixed Modelling (1) will evaluate a model including main effects for Group (Arm A vs Arm B), Time (Arm A BL vs FU1, Arm B FU1 vs Follow-up2 [FU2]) and the main interaction term of interest: Group X Time. An additional covariate of initial global cognitive status will be added to this analysis to control for different potential starting points for the two arms at the different time-points.

Phase III: Equivalence of the two arms at follow up III will be tested using a two one-sided test (TOST42) .

Clinical Response Prediction will be addressed by multiple regression examining relationships between baseline predictor variables (i.e; cognitive profile) and cognitive change scores.

A saliva sample will be collected during baseline measurements to examine Apolipoprotein E 4(APOE 4) and Brain-derived neurotrophic factor (BDNF) ValMet genotype status. These will be collected via a DNA sample. The DNA sample consists of a participants saliva. A participant will be instructed to spit a certain amount of Saliva into a funnel leading to a tube which will be sealed and sent for analysis. DNA samples will be stored in Room 403, level 4, 94 Mallett Street, Camperdown and analyses will be conducted in Room 303 Level 3, 94 Mallett Street, Camperdown by AI AProf Kwok. BDNF Val/Met polymorphism (rs6265) will be analysed using the Taqman SNP BDNF-AS Assay (SNP ID: rs6265).

1. Gueorguieva, R. & Krystal, J.H. Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry 61, 310-317 (2004).
2. Lampit A, et al. The timecourse of global cognitive gains from supervised computer-assisted cognitive training: a randomised, active-controlled trial in elderly with multiple dementia risk factors. Journal of Prevention of Alzheimer’s Disease 1, 33-39.
3. Fiatarone Singh, M.A., et al. The Study of Mental and Resistance Training (SMART) Study—Resistance Training and/or Cognitive Training in Mild Cognitive Impairment: A Randomized, Double-Blind, Double-Sham Controlled Trial. Journal of the American Medical Directors Association 15, 873-880 (2014).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
2/11/2022
Actual
Date of last data collection
Anticipated
2/08/2023
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11182 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 11183 0
Brain and Mind Centre - University of Sydney - Camperdown
Recruitment postcode(s) [1] 23023 0
2031 - Randwick
Recruitment postcode(s) [2] 23024 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 299837 0
Government body
Name [1] 299837 0
National Health and Medical Research Council
Country [1] 299837 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 299190 0
None
Name [1] 299190 0
Address [1] 299190 0
Country [1] 299190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300714 0
University of Sydney Research Ethics Committee
Ethics committee address [1] 300714 0
Ethics committee country [1] 300714 0
Australia
Date submitted for ethics approval [1] 300714 0
18/06/2018
Approval date [1] 300714 0
07/03/2019
Ethics approval number [1] 300714 0
2018/669

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

Contacts
Principal investigator
Name 84578 0
Prof Michael Valenzuela
Address 84578 0
Regenerative Neuroscience Group
Brain & Mind Centre and Sydney Medical School
Room 408, Level 4, M02K
100 Mallett St,
Camperdown,
NSW,
2050
Country 84578 0
Australia
Phone 84578 0
+61 2 9114 4135
Fax 84578 0
Email 84578 0
[email protected]
Contact person for public queries
Name 84579 0
Polly Barr
Address 84579 0
Regenerative Neuroscience Group
Brain & Mind Centre and Sydney Medical School
Room 408, Level 4, M02K
100 Mallett St,
Camperdown,
NSW,
2050
Country 84579 0
Australia
Phone 84579 0
+61478677239
Fax 84579 0
Email 84579 0
[email protected]
Contact person for scientific queries
Name 84580 0
Polly Barr
Address 84580 0
Regenerative Neuroscience Group
Brain & Mind Centre and Sydney Medical School
Room 408, Level 4, M02K
100 Mallett St,
Camperdown,
NSW,
2050
Country 84580 0
Australia
Phone 84580 0
+61478677239
Fax 84580 0
Email 84580 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
In order to maintain data protection and participant confidentiality we will not be sharing participant data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1548Study protocol    375380-(Uploaded-07-03-2019-10-47-16)-Study-related document.pdf
1549Informed consent form    375380-(Uploaded-07-03-2019-10-47-39)-Study-related document.pdf



Results publications and other study-related documents

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