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Trial registered on ANZCTR
Registration number
ACTRN12621001094864
Ethics application status
Approved
Date submitted
24/06/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Workplace evaluation of online procedures to manage risk of both musculoskeletal and stress-related mental health disorders.
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Scientific title
Workplace evaluation of online procedures to manage risk of both musculoskeletal and stress-related mental health disorders in manufacturing workers.
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Secondary ID [1]
304468
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NIL
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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:
work-related musculoskeletal disorders
322297
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Work-related mental health disorders
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Condition category
Condition code
Public Health
319972
319972
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0
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Other public health
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Musculoskeletal
320403
320403
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0
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Other muscular and skeletal disorders
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Mental Health
320404
320404
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention sites will implement the toolkit in their workplace. The toolkit implementation is a 12 month cycle of identifying hazards and developing actions to address hazards. This will be part of their normal occupational health and safety management system. The research team will be attending the monthly RMT meetings and maintain regular contact with the intervention sites to ensure implementation progresses smoothly.
The toolkit was designed to enable comprehensive diagnosis of the unique musculoskeletal disorder (MSD) hazard profiles of different jobs, based on results from a survey covering both physical and psychosocial hazards and an MSD risk indicator. Workers participate in developing risk control actions that are customised to their job’s specific hazard profile and that accord with the risk control hierarchy, following online guidance. To promote its uptake and sustainable use in ordinary workplaces, the toolkit was formulated in accord with a framework developed by the World Health Organisation and follows implementation science principles as summarised in the Quality Implementation Framework. For further details see www.aphirm.org.au.
As part of the toolkit implementation, workplaces establish a Risk Management Team (RMT) to oversee implementation. The RMT oversees the implementation of the toolkit in a designated workgroup (20-30 workers x 3 workgroups) and consists of managers, supervisors and workers in the designated workgroup. They will meet monthly for approximately 1 hour, with an additional meeting required during the 'create action plan' stage. They are guided by the toolkit’s interactive online procedures through the following steps, repeating this cycle annually:
1. Hazard identification (anonymous online survey of workers to quantify MSD risk level in terms of a validated discomfort/ pain score, stress measure, and the self-reported incidence of any absence from work due to MSD pain, as well as severity of each of a comprehensive set of work-related physical and psychosocial hazards). The online survey takes approximately 15mins and occurs within the first few weeks of toolkit implementation. The toolkit automatically determines the top 10 hazards.
2. Identification of causes and solutions for each of the top 10 hazards (a second online survey completed by workers - taking approx. 15 mins). This will occur approximately 2 weeks after the first survey - timing will be dependant on operation/production demands within the participating business.
3. Action plan drafted by RMT, based on step 2. The RMT will need to meet twice, (1.5hrs per meeting) to complete this step. The drafting of the action plan will commence within two weeks of receiving the second survey responses however, the timing of the RMT meeting will depend on demands and staff availability within participating businesses. Examples of actions to be implemented include staffing changes, the introduction of new equipment, changes to rostering systems. It is expected the implementation of the action plan will occur within 8 weeks following the collection of data from the identification of causes/solutions survey.
4. Monitor and evaluate resultant actions and changes through ongoing monthly meetings & communication with designated workgroup. Workers will complete an online survey (review feedback survey) at the end of the 12 month cycle to provide feedback on the helpfulness of each action (10 mins).
5. Evaluate outcomes, based primarily on a comparison of initially measured MSD risk and hazard profiles with those measured 12 months after implementation of the toolkit. At the end of the 12-month cycle, workers complete the online hazard survey so that a comparison can be made to the initial survey results. This is a separate survey from the online review feedback survey.
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Intervention code [1]
320818
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Prevention
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Comparator / control treatment
The control group consists of organisations that will not be implementing the toolkit. They will be undertaking their usual MSD risk management practices. Usual risk management practices vary greatly between organisations and may include hazard identification strategies (e.g. checklists), incident reporting & investigation procedures, and risk assessment strategies (e.g., expert observation, consultation with workers). Control sites will undertake a baseline hazard identification survey and then follow up at 12 months. At the completion of the project, the control sites have the option to implement the toolkit which is freely available online.
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Control group
Active
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Outcomes
Primary outcome [1]
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Physical hazard scores are a component of the toolkit and calculated using an algorithm that is built into the software.
The questions used to determine hazard ratings are sourced from: Work Organisation Assessment Questionnaire (WOAQ) (Griffiths A, Cox T, Karanika M, Khan S, Tomas JM. Work design and managmeent in the manufatcuring sector: development and validation of the Work Organisation Assessment Questionnaire. Occupational Environmental Medicine. 2006;63(10):669–675). Job Content Questionnaire (Karasek R, Brisson C, Kawakami N, Houtman I, Bongers P, Amick B. The Job Content Questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. Journal of Occupational Health Psychology. 1998;3(4):322.]), the Job Diagnostic Survey (Hackman JR, Oldham GR. Development of the job diagnostic survey. Journal of Applied Psychology. 1975:60(2):159.]), a Work Characteristics survey (Marlow P, Pinder A, Gould V. Benchmarking manual handling performance in Welsh care homes. 2005. http://library.safework.sa.gov.au/fullRecord.jsp?recnoListAttr=recnoList&recno=33702.), and our previous research on effects of highly repetitive, externally-paced work on employee wellbeing (Macdonald, W.A. 2000. Workload, fatigue and job satisfaction in repetitive blue-collar work. In Human System Interaction: Education, Research and Application in the 21st Century, edited de Waard et al, Shaker Publishing BV, Maastricht, The Netherlands), (Macdonald, W. 2003. Work demands and stress in repetitive ‘blue-collar’ work. In Work Stress: Studies of the context, content and outcomes of stress. A Book of Readings. Chapter 7 (pp.139-163). Baywood: New York.).
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Assessment method [1]
327846
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Timepoint [1]
327846
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This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
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Primary outcome [2]
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Psychosocial hazard scores are a component of the toolkit and calculated using an algorithm that is built into the software.
The questions used to determine hazard ratings are sourced from: Copenhagen Psychosocial Questionnaire (Kristensen, Tage & Hannerz, Harald & Hogh, Annie & Borg, Vilhelm. (2006). The Copenhagen Psychosocial Questionnaire - A tool for the assessment and improvement of the psychosocial work environment. Scandinavian journal of work, environment & health. 31. 438-49. 10.5271/sjweh.948.)
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Assessment method [2]
327847
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Timepoint [2]
327847
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This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
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Secondary outcome [1]
396760
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Musculoskeletal pain score is used to assess musculoskeletal pain and is derived from the Nordic Musculoskeletal Questionnaire (Joanne O. Crawford, The Nordic Musculoskeletal Questionnaire, Occupational Medicine, Volume 57, Issue 4, June 2007, Pages 300–301, https://doi.org/10.1093/occmed/kqm036).
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Assessment method [1]
396760
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Timepoint [1]
396760
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This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
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Secondary outcome [2]
397339
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Stress score will be assessed using Copenhagen Psychosocial Questionnaire (Kristensen, Tage & Hannerz, Harald & Hogh, Annie & Borg, Vilhelm. (2006). The Copenhagen Psychosocial Questionnaire - A tool for the assessment and improvement of the psychosocial work environment. Scandinavian journal of work, environment & health. 31. 438-49. 10.5271/sjweh.948.).
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Assessment method [2]
397339
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Timepoint [2]
397339
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This outcome will be assessed at baseline, and again in 12 month's time (following the completion of the intervention.)
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Eligibility
Key inclusion criteria
This is an industry based trial focussed on high risk industry sectors of manufacturing and logistics. Businesses must be larger than 50 employees and based in the State of Victoria. Must be able to include 60 workers in different work groups of at least 15 employees.
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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?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Prevention
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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)
Businesses were included in the study and allocated a number. An independent researcher received these numbers and assigned them using a random number allocator in excel as either the control or intervention group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation process was used in excel.
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Given the data structure of participants within working groups within organisations (multilevel data), the results will be analysed with a mixed effects model. Power and sample size calculations were conducted in R (version 4.0.3 -- "Bunny-Wunnies Freak Out") to detect a change in physical demands between intervention and control of 0.5. We made the assumptions that the baseline physical demands in manufacturing would have a mean of 3.6 and an SD 0.8, The ICC was set conservatively at 0.05.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
28/05/2021
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Date of last participant enrolment
Anticipated
30/08/2021
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Actual
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Date of last data collection
Anticipated
30/08/2022
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Actual
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Sample size
Target
360
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Accrual to date
180
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
308826
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Government body
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Name [1]
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WorkSafe Victoria
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Address [1]
308826
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1 Malop Street, Geelong, Victoria, 3220
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Country [1]
308826
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Kingsbury Drive, Bundoora, Victoria, 3086
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
309746
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Country [1]
309746
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308739
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La Trobe University Human Research Ethics Committee
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Ethics committee address [1]
308739
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La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
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Ethics committee country [1]
308739
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Australia
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Date submitted for ethics approval [1]
308739
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17/02/2021
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Approval date [1]
308739
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15/03/2021
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Ethics approval number [1]
308739
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HEC21052
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Summary
Brief summary
La Trobe University’s Centre for Ergonomics & Human Factors developed an evidence-based risk management ‘toolkit’ intended for routine workplace use to manage risk of work-related musculoskeletal disorders (MSDs) more effectively. It is called APHIRM (a Participative Hazard Identification & Risk Management) toolkit. This toolkit has been further developed to manage work-related mental health disorders (MHDs), as well as MSDs.
The primary aim of this study is to evaluate both the implementation processes and impact of this toolkit when used by workers in the Manufacturing sector as part of their workplace procedures to control MSD & MHD hazard and risk levels. Implementation by workplace personnel will be supported by researchers, who will use workplace feedback to amend some toolkit components if needed to maximise its practicability and ease of use.
The research team is recruiting six medium/large organisations in the Manufacturing industry sector. Organisations will be randomly assigned to either the intervention group or the control group. The intervention group will receive free toolkit training and full support to implement the toolkit. The control group will have an opportunity to implement the toolkit at the end of the study. Workers in both the intervention and control organisations will complete an online survey to determine their pain/discomfort, and levels of stress. They will also provide responses to questions related to their workplace which will identify the top 10 hazards. These surveys will be undertaken at baseline and 12 months post intervention.
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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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A/Prof Jodi Oakman
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Address
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La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
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Country
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Australia
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Phone
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+61 03 94793235
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Fax
111722
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Email
111722
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[email protected]
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Contact person for public queries
Name
111723
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Ms Natasha Kinsman
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Address
111723
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La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
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Country
111723
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Australia
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Phone
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+61 03 94795392
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Fax
111723
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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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A/Prof Jodi Oakman
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Address
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La Trobe University, HS2, Kingsbury Drive, Bundoora, Victoria, 3086
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Country
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Australia
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Phone
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+61 03 94793235
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Fax
111724
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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
We do not have ethics approval to share the data.
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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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