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Trial registered on ANZCTR
Registration number
ACTRN12623001040651
Ethics application status
Approved
Date submitted
7/09/2023
Date registered
26/09/2023
Date last updated
18/10/2023
Date data sharing statement initially provided
26/09/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
An Open Label Pilot Study of Photo-Biomodulation Therapy.
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Scientific title
An Open Label Pilot Study of Photo-Biomodulation Therapy in Healthy Adults aged 50 to 70years.
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Secondary ID [1]
310560
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Nil known
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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:
Cognitive impairment
331394
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Condition category
Condition code
Neurological
328139
328139
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0
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Studies of the normal brain and nervous system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
An open label pilot study of photo-biomodulation therapy (PBMT).
The main goal of the study is to examine the safety and tolerability of transcranial PBMT with a helmet style of device for healthy participants aged 50-70 years. Participants will be on their “treatment as usual” regimen which implies that they will continue to take all their regular medications. The PBMT treatment will be adjunctive.
The proposed open-label trial will comprise of a single treatment arm, whereby healthy participants aged 50 to 70 years (N=30) will receive PBMT treatment twice per week for 12 weeks. For each session, the participant will be instructed to sit upright in a chair with their eyes open whilst wearing the helmet device to receive 20 minutes (exposure time) of photo-biomodulation treatment with pulse mode setting, square wave time 20Hz/min and light intensity of 20%. PBMT treatments will occur twice a week with at least 2 days apart in between at the Thompson Institute. The PBMT session will be performed by trained PBMT technicians and researchers. All participants will be informed that they will receive PBMT treatment. Neuropsychological and self-report assessments along with Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) will occur at entry into the study (week 0) and after the treatment period (week 12). If a participant is unable to attend or misses a treatment session, details of the deviation, including reason for failure to attend, will be recorded in the source documentation. If participants miss more than two weeks of PBMT treatment, they will be excluded from the study.
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Intervention code [1]
326957
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Participant safety and tolerability (number and severity of adverse events). Adverse events will be defined by any unfavourable or unintended symptoms or distress associated with PBMT which may or may not be related to the treatment (e.g. dizziness, nausea, headache, dry mouth, discomfort, emotional distress). Adverse events will be recorded and categorised according to the Common Terminology Criteria for Adverse Events (CTCAE5). These will be recorded through weekly questionnaires that participants fill out with a yes/no response followed by an open response questionnaire to detail the event if one has occurred.
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Assessment method [1]
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Timepoint [1]
336016
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Weekly questionnaires during the 12weeks of treatment.
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Primary outcome [2]
336017
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Program completion (actual PBMT therapy completed). Participants will be assessed as having completed the program if they have attended at least 75% of the planned therapy over the coarse of the 12 weeks. This will be recorded via an attendance sheet where the researchers indicate if they have completed their therapy for that day.
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Assessment method [2]
336017
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Timepoint [2]
336017
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Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [1]
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Change in cognitive function as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) assessment
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Assessment method [1]
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Timepoint [1]
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [2]
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Change in neuroanatomical structure as assessed by Magnetic Resonance Imaging (MRI)
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Assessment method [2]
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Timepoint [2]
426488
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [3]
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Change in depression results as assessed by the self-report Geriatric Depression Scale,
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Assessment method [3]
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Timepoint [3]
426489
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [4]
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Change in brain activity as assessed by the Electroencephalography (EEG)
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Assessment method [4]
426490
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Timepoint [4]
426490
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [5]
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Change in sleep functioning as measured by Pittsburgh Sleep Quality Index
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Assessment method [5]
426491
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Timepoint [5]
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [6]
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Change in self-reported memory functioning as assessed by Everyday Memory Questionnaire
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Assessment method [6]
426492
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Timepoint [6]
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [7]
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Change in dynamic brain activity as assessed by Magnetic Resonance Imaging (MRI)
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Assessment method [7]
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Timepoint [7]
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [8]
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Change in neurochemistry as assessed by Magnetic Resonance Imaging (MRI)
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Assessment method [8]
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Timepoint [8]
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [9]
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Change in anxiety results as assessed by the self-report Geriatric Anxiety Inventory,
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Assessment method [9]
426907
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Timepoint [9]
426907
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [10]
426908
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Change in alcohol use as assessed by the self-report Audit-C questionnaire.
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Assessment method [10]
426908
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Timepoint [10]
426908
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Secondary outcome [11]
426909
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Change in quality of life results as assessed by the self-report Assessment of Quality of Life questionnaire.
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Assessment method [11]
426909
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Timepoint [11]
426909
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1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
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Eligibility
Key inclusion criteria
- Persons aged 50-70 years.
- Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF).
- Participants must be able to undergo MRI, undertake neuropsychological and EEG assessments, and tolerate the PMBT therapy.
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Diagnosed dementia and mild cognitive impairment
- Significant psychiatric history including psychosis, bipolar disorder, major depressive disorder including suicidality.
- Any unstable medical (e.g., severe/uncontrolled hypertension) or neurological condition (e.g., Parkinson’s Disease)
- Severe cardiovascular disease, history of stroke, recent myocardial infarction
- Any contraindication to MRI or PBMT therapy
- Development of serious, adverse, or unexpected events/reactions during the trial
- Previous reaction to PBMT therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Feasibility/Acceptability pilot study, Desired sample size N=30.
Statistical analyses will be generalised linear models (GLMs), analysis of the relative change index, frequency statistics, and use appropriate descriptive statistics, t-tests, ANOVA/ANCOVA to evaluate pre-post changes from baseline to post intervention follow up looking for changes that may signal initial efficacy of intervention.
A significance level of p<.05 will be utilised where required. Data will be inspected for outliers and any spurious data will be corrected or removed prior to analysis. Brain imaging data will be analysed as per internationally accepted analyses routines (eg FSL and SPM).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/10/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/07/2024
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Actual
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Sample size
Target
30
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
314764
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Commercial sector/Industry
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Name [1]
314764
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Brain Gear Inc
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Address [1]
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D-618, Techno4-ro 17 Yuseong-gu, Daejeon 34013
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Country [1]
314764
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Korea, Republic Of
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Primary sponsor type
University
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Name
The University of the Sunshine Coast
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Address
Thompson Institute, The University of the Sunshine Coast, 12 Innovation Parkway, Birtinya QLD 4575, Sunshine Coast
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Country
Australia
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Secondary sponsor category [1]
316749
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None
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Name [1]
316749
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Address [1]
316749
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Country [1]
316749
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313772
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The University of the Sunshine Coast Human Research Ethics Committee
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Ethics committee address [1]
313772
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UniSC Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs, Queensland 4556
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Ethics committee country [1]
313772
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Australia
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Date submitted for ethics approval [1]
313772
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04/09/2023
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Approval date [1]
313772
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15/09/2023
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Ethics approval number [1]
313772
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Summary
Brief summary
This study is an open-label trial investigating the safety, feasibility, and tolerability of photo-biomodulation Therapy (PBMT) on healthy participants aged 50 to 70 years. Photo-biomodulation (PBMT) employs red or near-infrared (NIR) light (600-1100nm) to stimulate healing, protect tissue from dying, increase mitochondrial function, improve blood flow, and tissue oxygenation (Dompe et al., 2020; Hamblin, 2018). PBMT can also act to reduce swelling, increase antioxidant defence, decrease inflammation, protect against apoptosis, and modulate microglial activation states (de Freitas & Hamblin, 2016; Hamblin, 2017). All these mechanisms of action strongly suggest that PBMT delivered to the head could be beneficial in cases of mild cognitive impairment and dementia (Hamblin, 2016; Hennessy & Hamblin, 2016). The study will also determine the relevant parameters of PBMT that will be used to design a larger randomised blinded trial. We hypothesize that the (1) PBMT intervention will be safe and tolerable for an older adult population and (2) the treatment will result in discernible changes in MRI measures and these will be correlated to improvements on neuropsychological assessment outcomes on the CANTAB that reflect decision making and working memory constructs, as well as EEG measures of attention and working memory. The 12-week intervention will include participants undergoing pre-treatment assessments (week 0), 12 weeks of PBMT (week 1-12), and post-treatment assessments (week 12). The PBMT trial will be evaluated against baseline verse follow up cognitive, psychological, and neuroanatomical changes, along with participant safety and tolerability (number and severity of adverse events) and program completion (actual treatment completed).
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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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Dr Sophie Andrews
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Address
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Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
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Country
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Australia
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Phone
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+61 754594476
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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 Sophie Andrews
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Address
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Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
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Country
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Australia
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Phone
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+61 754594476
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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 Sophie Andrews
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Address
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Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
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Country
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Australia
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Phone
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+61 754594476
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Fax
129316
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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
As this is a feasibility study, we do not plan to share the individual data, however, manuscripts containing overall average outcomes are planned.
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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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