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Trial registered on ANZCTR
Registration number
ACTRN12623000891628
Ethics application status
Approved
Date submitted
4/08/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Treating dementia-related sleep deprivation with weighted blankets
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Scientific title
Weighted blankets as a non pharmacological sleep intervention for people with dementia: A pilot randomized controlled crossover effectiveness-implementation trial
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Secondary ID [1]
310128
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Behavioural and Psychological Symptoms of Dementia
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Condition category
Condition code
Neurological
327554
327554
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0
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Dementias
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Public Health
327893
327893
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A weighted blanket, up to 12% of the person’s body weight, for overnight use for two consecutive weeks under nursing supervision. No wash out period is required as the effects of the weighted blanket cease on removal of the the weight. The intervention will follow the service Clinical Protocol for Sensory Modulation which states the user needs to be able independently remove or free themselves from the weighted blanket. Use of weighted blankets will be recorded daily in patient records. Weighted blankets used are commercially available and have soft glass bead fillings and a fleece cover.
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Intervention code [1]
326544
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Treatment: Devices
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Comparator / control treatment
Treatment as usual, which is usual hospital blankets that are not weighted overnight.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in sleep duration as measured via the Withings sleep analyser and/or fitbit work
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Assessment method [1]
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Timepoint [1]
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Sleep data collection will occur at three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Primary outcome [2]
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Change in sleep efficiency as measured via the Withings sleep analyser and/or fitbit work
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Assessment method [2]
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Timepoint [2]
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Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Primary outcome [3]
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Changes in frequency and severity in sleep disordered behaviours assessed as a composite outcome as measured by the sleep disorder inventory (SDI).
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Assessment method [3]
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Timepoint [3]
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Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Secondary outcome [1]
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Changes in responsive behaviours as measured by the Neuropsychiatric Inventory (NPI). A validated tool that measures severity levels of behavioral symptoms.
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Assessment method [1]
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Timepoint [1]
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NPI will occur at three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Secondary outcome [2]
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Changes in falls incidents as measured via the service safety learning system.
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Assessment method [2]
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Timepoint [2]
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Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Secondary outcome [3]
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Changes in restrictive practice incidents as measured by the service safety learning system.
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Assessment method [3]
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Timepoint [3]
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Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Secondary outcome [4]
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Changes in as needed psychotropic medication use as recorded in patient clinical notes.
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Assessment method [4]
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Timepoint [4]
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Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
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Eligibility
Key inclusion criteria
Adults admitted to the specialised dementia care unit with severe dementia as assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and assessed as having at least one sleep problem as assessed using the Sleep Disorder Inventory (SDI).
Trialling a weighted blanket as a non-pharmacological sleep intervention, will be discussed with potential participants nearest relative/guardian within their usual multi-disciplinary care and consent gained by proxy. The researchers will provide educational sessions about the trial to families and information about the project will be included in unit newsletters for families. Following consent, a weighted blanket risk assessment will be conducted by an occupational therapist to determine safety and suitability.
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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
People who are unable to independently remove a lesser weight blanket (3kg) or who are receiving palliative care.
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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)
Central randomisation by independent researcher; allocation concealed from investigators, recruitment and site staff until the time of randomisation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence stratified by clinical pod and in random blocks of two or four.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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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
This study will aim to recruit between 14-18 participants, in accordance with findings that a pilot study should involve at least 12 subjects to ensure considerable precision in mean and variance values, and pragmatic consideration of what can realistically be implemented and collected within the time frames in this clinical setting.
The data collected to evaluate the use of the weighted blankets will be interpreted using a
convergent-parallel design, in which data will first be analysed and synthesised individually and then triangulated to allow for a detailed complementary understanding of the two data sets. All analyses will be on an intention to treat basis. For the primary outcome, the sleep duration and sleep efficiency (continuous variables) will be compared between the intervention and control groups (as a dichotomous variable) using independent sample t-tests. For the primary outcome, the prevalence of sleep problems (the SDI score) will be compared between the intervention and control groups (as a dichotomous variable) in the population by applying a X2-test. Different parametric and non-parametric tests will be used to determine the significant differences between experimental and control groups for secondary outcomes. A Repeated-Measures of Analysis of Variance (ANOVA) method for multiple measures of the same outcome variables at different time points will be used to determine changes in the outcomes within and between groups. Further a mixed method approach will be used to measure the effect of intervention, considering the random variability within variables at different study points. Level of significance will be a = 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/08/2023
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Actual
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Date of last participant enrolment
Anticipated
27/11/2023
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Actual
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Date of last data collection
Anticipated
17/03/2024
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
25325
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Repat Neuro-Behavioural Unit - Daw Park
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Recruitment postcode(s) [1]
41029
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5041 - Daw Park
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Dementia Australia
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Address [1]
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27 Conyngham Street, Glenside SA 5065
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
GPO Box 2100, Adelaide SA 5001
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Repat Neuro Behavioural Unit
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Address [1]
316232
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Repat Health Precinct, 216 Daws Road, DAW PARK SA 5041
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Country [1]
316232
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313405
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
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Level 3, Roma Mitchell Building
136 North Terrace,
Adelaide SA 5000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/06/2022
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Approval date [1]
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03/08/2022
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Ethics approval number [1]
313405
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2020/HREC00028
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Summary
Brief summary
Sleep disturbances are common among people living with dementia, with consequences far reaching for the person, their carers and care systems. Sleep disturbances result in decreased quality of life for the person with dementia and cause significant stress for caregivers. Additionally, sleep disturbances are associated with increased admissions to care settings and healthcare costs. As such, sleep disturbances for people living with dementia are recognised as a major challenge that requires addressing. Nonpharmacological interventions are prioritised for the treatment of sleep disturbances; however, medication is frequently used, with a range of risks (including increased falls and confusion). Currently there is no gold standard sleep intervention for people with dementia.
Use of weighted blankets is emerging as a safe sleep intervention option, although little is known about the effectiveness of use for people with dementia. A staged investigation will be conducted to 1) examine the effectiveness of weighted blankets as a sleep intervention for people with dementia; 2) understand the barriers and facilitators to use of weighted blankets; and 3) co-design a plan for future implementation across a range of settings.
This trial reports on stage 1 of the project. During this stage we will recruit 14-18 participants living in a dementia-care unit to be randomly divided into either the intervention group or usual care group. The intervention group will use the weighted blanket overnight for two weeks, then the groups swap. A range of measurements, including sleep duration and quality, and medication use, to determine the blankets’ impact. We hypothesize that participants in the intervention group will have improved sleep outcomes and reduced behavioral and psychological symptoms of dementia.
Research questions:
1. Are weighted blankets an effective and feasible sleep intervention for people with behavioural and psychological symptoms of dementia?
2. What are the implementation strategies for uptake of weighted blankets for people with behavioural and psychological symptoms of dementia in an inpatient setting?
3. What are the recommended implementation strategies for uptake of weighted blankets for people living with dementia across a range of settings?
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Trial website
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Trial related presentations / publications
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Public notes
This research is funded by the Hazel Hawke Research in Dementia Care, Dementia Australia. More information about the project is available on the Dementia Australia website: https://www.dementia.org.au/research/foundation/our-researchers
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Contacts
Principal investigator
Name
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Dr Suzanne Dawson
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Address
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Flinders University
GPO Box 2100
Adelaide SA 5001
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Country
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Australia
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Phone
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+61 0435 716 477
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Suzanne Dawson
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Address
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Flinders University
GPO Box 2100
Adelaide SA 5001
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Country
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Australia
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Phone
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+61 0435 716 477
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Suzanne Dawson
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Address
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Flinders University
GPO Box 2100
Adelaide SA 5001
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Country
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Australia
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Phone
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+61 0435 716 477
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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