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Trial registered on ANZCTR
Registration number
ACTRN12624001110572
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The development and pilot evaluation of an online mental health training program for managers in the aged care sector
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Scientific title
The development and pilot evaluation of the impact of an online mental health training program on manager confidence, knowledge, stigma and behaviour in supporting employee mental health in the aged care sector
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Secondary ID [1]
312748
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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:
Confidence in supporting employee mental health
334783
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Mental health knowledge
334784
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Mental health stigma
334787
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Behaviour towards employee mental health
335133
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Condition category
Condition code
Mental Health
331345
331345
0
0
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Depression
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Mental Health
331346
331346
0
0
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Anxiety
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Mental Health
331347
331347
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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
A previously evaluated skills-based manager mental health training program (ACTRN12619001496101) will be adapted, in partnership with advisors from the aged care sector to ensure the program addresses the unique needs of this cohort of workers. The program will consist of three modules covering the following content:
1. An introduction to mental disorders commonly seen in the workplace
- How to recognise mental illness
- Your responsibilities as a manager
2. How to respond to workers who are symptomatic or unwell due to mental health reasons (responsive strategies)
- Identifying people at risk
- Providing support
- Talking to employees about mental health
- Encouraging someone to get help
- Modifying work to help recovery
- Helping employees return to work
3. How to minimise work-related mental health risk factors for staff (preventive strategies).
- How to be a responsible manager
- Creating a collaborative workplace
- Managing your team
- Managing difficult situations
Each training module comprises of text, activities, short videos and practice exercises to complete as part of the training. It is expected the entire program will take approximately 2 hours. The program has been designed for participants to complete at their own pace, at any time within the 6-month data collection period. The intervention will be delivered through a mobile responsive website and participants can complete the intervention on a desktop, laptop, tablet or smart phone.
Adherence to the online training program will be monitored through the online training platform. Reminder emails will be sent to participants who have not completed the program. Data will be available through the research platform on what percentage of the training program has been completed.
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Intervention code [1]
329280
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Behaviour
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Comparator / control treatment
No control group in this pilot study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339111
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Manager confidence in effectively responding to employees experiencing mental health issues and in implementing techniques to create a mentally healthy work environment.
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Assessment method [1]
339111
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Manager confidence will be measured at baseline and after mental health training using a 6-item self-report scale used in previous trials for manager mental health training (Milligan-Saville JS, Tan L, Gayed A, et al. Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. The Lancet Psychiatry. 2017;4(11):850-858. and Gayed A, Bryan BT, LaMontagne AD, et al. A Cluster Randomized Controlled Trial to Evaluate Headcoach: An Online Mental Health Training Program for Workplace Managers. Journal of occupational and environmental medicine. 2019).
Each item contains 6 different mental health scenarios in which managers rate their level of confidence from 1 (Not at all confident) to 5 (Extremely confident).
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Timepoint [1]
339111
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Primary outcome [2]
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User experience of training program
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Assessment method [2]
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User experience will be measured using a self-report scale previously used in other manager mental health training trials (Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med) . The scale asks about usefulness of each module of the training program using a 5-point likert scale.
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Timepoint [2]
339112
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Secondary outcome [1]
438605
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Managers' knowledge about common mental health conditions within the workplace.
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Assessment method [1]
438605
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The measurement used is the Mental Health knowledge schedule (MAKS) and consists of 12 items scored on a 5-point scale (1-5) with ‘don’t know’ coded as neutral (ie: 3) and assesses stigma-related mental health knowledge among the general public.
Evans-Lacko, S., Little, K., Meltzer, H., Rose, D., Rhydderch, D., Henderson , C., and Thornicroft, G. Development and Psychometric Properties of the Mental Health Knowledge Schedule. (2010). Can J Psychiatry. 55: 440-448.
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Timepoint [1]
438605
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Secondary outcome [2]
438606
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Managers' attitudes towards mental health in the workplace
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Assessment method [2]
438606
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The measure used to assess manager attitude will be a 10-item likert scale, containing 10 statements for which the participant answers with their level of agreement from 1 (strongly disagree) to 5 (strongly agree). The scale was developed by the researchers that was used in a previously conducted RCT evaluating supervisor training (Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., Glozier, N. & Harvey, S. B. 2019. A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. J Occup Environ Med,)
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Timepoint [2]
438606
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Secondary outcome [3]
438607
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Managerial stigma towards employees experiencing mental health issues
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Assessment method [3]
438607
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Measured with a 12-item likert scale, in which participants answer their level of agreement from 1 (strongly disagree) to 6 (strongly agree). Developed in previous research (Shann C, Martin A, Chester A. Improving workplace mental health: a training needs analysis to inform beyondblue’s online resource for leaders. (2014). Asia Pac J Hum Resources, 2014;52(3):298–315.
Martin A, Giallo R. Confirmatory factor analysis of a questionnaire measure of managerial stigma toward employees with depression. (2015). Stress & Health, 32(5):621-628)
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Timepoint [3]
438607
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Secondary outcome [4]
438608
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Manager behaviour (both responsive behaviour to employees experiencing mental illness and preventative behaviour to prevent and reduce stress at work)
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Assessment method [4]
438608
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Behaviour is measured using a 15 item-likert scale with 6 items measuring responsive behaviour to employees experiencing mental illness and 9 items measuring preventative behaviour to prevent and reduce stress at work. This scale has been used in previous trials investigating mental health interventions (Gayed A, Bryan BT, LaMontagne AD, et al. A Cluster Randomized Controlled Trial to Evaluate Headcoach: An Online Mental Health Training Program for Workplace Managers. Journal of occupational and environmental medicine.)
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Timepoint [4]
438608
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Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
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Eligibility
Key inclusion criteria
- Working in the aged care sector
- Supervising at least one employee in the aged care sector
- 18 years or above
- Residing and working in Australia
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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
Educational / counselling / training
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
20/06/2024
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Date of last participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
200
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Accrual to date
11
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
317179
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Other
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Name [1]
317179
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Philanthropic funding from John and Anna Belfer (Belanna Pty Ltd)
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Address [1]
317179
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Country [1]
317179
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Australia
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Primary sponsor type
Other
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Name
Black Dog Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
319443
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None
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Name [1]
319443
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Address [1]
319443
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Country [1]
319443
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315923
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
315923
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
315923
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Australia
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Date submitted for ethics approval [1]
315923
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22/11/2023
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Approval date [1]
315923
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01/12/2023
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Ethics approval number [1]
315923
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iRECS4812
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Summary
Brief summary
This research aims to evaluate the feasibility, acceptability and preliminary efficacy of a mental health training program for managers in the aged care industry. This skills-based mental health training program has been shown to be effective in other occupational groups and has been tailored, alongside representatives from the aged care workforce, to suit the needs of those working in the aged care sector. The efficacy of the program will be evaluated through a pre-post intervention pilot trial design which aims to address the following research questions: 1. Is the delivery and content an adapted version of a previously evaluated manager training program tailored to managers working in Aged Care meeting the needs for this group? 2. Does training managers through a tailored workplace mental health program increase a) their knowledge in how to best support the mental health needs of the staff they supervise, b) their confidence to support the mental health needs of the staff they supervise and c) their application of responsive and preventive strategies to minimise psychosocial hazards in the workplace for the staff they supervise?
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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
136230
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Dr Mark Deady
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Address
136230
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
136230
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Australia
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Phone
136230
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+61 29065 9144
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Fax
136230
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Email
136230
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[email protected]
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Contact person for public queries
Name
136231
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Dr Aimee Gayed
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Address
136231
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
136231
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Australia
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Phone
136231
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+61290659043
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Fax
136231
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Email
136231
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[email protected]
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Contact person for scientific queries
Name
136232
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Dr Aimee Gayed
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Address
136232
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Black Dog Institute, Hospital Road Randwick NSW 2031
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Country
136232
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Australia
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Phone
136232
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+61290659043
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Fax
136232
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Email
136232
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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
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24109
Ethical approval
388293-(Uploaded-19-08-2024-11-03-03)-231122 iRECS4812 More than low risk application - Approved.pdf
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.
Download to PDF