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Trial registered on ANZCTR
Registration number
ACTRN12620001026910
Ethics application status
Approved
Date submitted
27/08/2020
Date registered
9/10/2020
Date last updated
9/10/2020
Date data sharing statement initially provided
9/10/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of the effect of a digital intervention called Workplace Wellbeing Assist on mental health in the workplace for Residential Aged Care staff.
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Scientific title
Evaluation of the effect of a digital intervention called Workplace Wellbeing Assist on the mental health of staff in the Residential Aged Care workplace.
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Secondary ID [1]
302385
0
None
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Universal Trial Number (UTN)
U1111-1239-8969
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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:
Workplace mental wellbeing
314299
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Condition category
Condition code
Public Health
312656
312656
0
0
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Health promotion/education
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Mental Health
313965
313965
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention under study is a digital monitoring and decision support tool known as 'Workplace Wellbeing Assist' (WWA). The digital tool is designed to enhance the workplace culture and mental wellbeing of direct-care staff working in residential aged care (RAC) facilities. WWA will be trialled and evaluated with RAC facility staff within the Department of Health and Human Services Victoria, Australia, West Division.
Materials: WWA will be available to participants to use via the internet on a mobile, tablet or computer. WWA does not diagnose or screen for mental health conditions.
Procedures: Managers and direct-care staff will be invited to participate in the intervention trial by direct work email invitation. Manager participation is a requirement for direct-care staff participation at any one RAC facility.
Direct-care staff participants will use WWA to complete a brief (approximately two-minute) Workplace Wellbeing Survey on a regular basis (recommended once a fortnight). The Workplace Wellbeing Survey will include 10 core questions, including four questions relating to personal wellbeing (e.g., how satisfied do they feel with their life) and six questions relating to workplace wellbeing (e.g., job control). Depending on the participant’s answers, the six workplace wellbeing questions may expand to (up to) 27 questions (e.g., I had little or no say over the way I do my job). These questions may take up to three minutes to complete depending on the number of questions.
In response to the direct-care staff member's answers to the four personal wellbeing questions WWA will present direct-care staff, (in real time), with three tailored resources to assist their personal mental wellbeing from a selection of 20 available resources. The tailored resources will be displayed on their personal direct-care staff dashboard on WWA. All available resources will be available to the participant to browse at leisure from the ‘Resource Library’ located on their dashboard. The resources include two videos to support understanding of WWA, two resources explaining mental health, as well as 16 resources to enhance personal mental wellbeing. For example, the personal wellbeing resources include, Relaxation, Gratitude, Distress tolerance / Self-soothing, Self-compassion, Communication, and Strengths building. Resources are text-based with graphics and include links to external sites for further information (e.g., BeyondBlue). Accessing the resources is expected to take approximately 20 minutes (excluding accessing content on external sites).
When a minimum of five direct-care staff have completed the six workplace wellbeing questions on the Workplace Wellbeing Survey in one fortnight cycle, data will be aggregated and be available on a manager dashboard on WWA to enable manager participants to monitor the workplace culture and take action to address workplace issues that may be affecting mental wellbeing. (Monitoring the manager dashboard is expected to take approximately five minutes each fortnight if issues have not been raised.)
To assist managers to take action, WWA will present managers with tailored resources from a selection of six available workplace wellbeing resources that correlate with the six workplace domains displayed on the manager dashboard: Job Demands; Job Control; Management Support; Team Support; Recognition; and Culture and Safety. Manager workplace resources include text-based and graphics, six animated videos, as well as links to external sites (e.g. HeadsUp) to assist managers to create a mentally healthy workplace. Managers will also have access to two videos to assist understanding of WWA, as well as two resources explaining mental health. The expected time commitment for a manger to read one text-based resource and access a video would be approximately 25 minutes.
Managers will have access to the workplace wellbeing resources and the personal wellbeing resources in the ‘Resource Library’ displayed on the manager dashboard. Managers will be able to use the personal wellbeing resources to enhance their own personal wellbeing if desired. However, managers will not be completing the Workplace Wellbeing Survey or be presented with personal wellbeing resources via WWA.
Overall, accessing the resources, how often and how long, is up to the participant. Depending on the participant’s interest in mental wellbeing considerable time could be spent reviewing the resources including following up with links to external sites.
The manager dashboard and direct-care staff dashboard are separate on WWA and neither has access to the other.
Following direct-care staff first login to WWA, WWA will present direct-care staff with the Participant Information Sheet and Consent Form and following consent the direct-care staff participant will complete demographic information (at Week 0), and three sets of online questionnaires designed to measure changes in the workplace climate and staff mental wellbeing (at Week 0, Week 12, and Week 24). The questionnaires will take approximately 25 minutes to complete. Participating managers and direct-care staff will complete demographic information (Week 0) and a System Useability Scale two weeks into the trial.
At Week 12 direct-care staff and manager participants will be invited to participate in a one-to-one, semi-structured interview (up to 60 minutes) via telephone, video-link or in-person (dependant on public health restrictions) to provide feedback on the acceptability, usability and usefulness of WWA. (Interview mode preference will be up to the individual participant, however, only telephone and video-link options will be available if public health restrictions do not permit in-person interviews.)
Mode of delivery: WWA will be delivered using the internet on a mobile, tablet or computer. Potential participants (both manager and direct-care staff) will be provided with access to WWA via a link to WWA. The potential participant will then be able to login to WWA and create an account by providing a strong password.
Frequency of use: It will be recommended that direct-care staff participants use WWA on a regular basis to monitor their mental wellbeing and complete the Workplace Wellbeing Survey, suggested fortnightly. Manager participants will be advised to monitor the manager dashboard on a regular basis, suggested fortnightly, to track the wellbeing of direct-care staff in the workplace. Manager and direct-care staff participants will be able to access resources on WWA as desired. WWA will be implemented in West Division RACS over a 24-week trial period.
Collected WWA data will be analysed for how many times the participant logged in to WWA, the number of times the Workplace Wellbeing Survey was completed, the amount of time spent on the dashboard, which resources were accessed including videos, and how often they were accessed, and the amount of time spent using them.
Data collected from the three waves of evaluation trial questionnaires will be analysed to assess the extent of any change in workplace climate and mental wellbeing over the trial period.
All evaluation trial data will be de-identified prior to any analysis. Only aggregate data will be reported.
Location: Participants will be able to access WWA over the internet in their workplace (RAC facility) or at home.
Adherence: Regular use of WWA will be encouraged for direct-care staff and mangers to achieve maximum benefit in assisting to create a mentally healthy workplace climate. Push notifications and email reminders will be sent to direct-care staff when activity using WWA is noted as falling, that is if a direct- care staff member has not completed the Workplace Wellbeing Survey on WWA for over two weeks or more. Manager participants will be sent fortnightly reminders announcing that new data from the direct- care staff completion of the Workplace Wellbeing Survey is available for their review and action where required.
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Intervention code [1]
315495
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Prevention
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Intervention code [2]
318433
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Lifestyle
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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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Change in perceptions of psychosocial safety climate in the workplace as measured by the Psychosocial Safety Climate (PSC-12) Questionnaire. (To be completed by RAC direct-care participants.)
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Assessment method [1]
324856
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Timepoint [1]
324856
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Baseline, 12 weeks (primary timepoint), and 24 weeks post commencement of the intervention.
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Secondary outcome [1]
385959
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Changes in psychological distress as measured by the Kessler Psychological Distress Scale (K10). (To be completed by RAC direct-care participants.)
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Assessment method [1]
385959
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Timepoint [1]
385959
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Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
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Secondary outcome [2]
385962
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Changes in mental wellbeing as measured by the Mental Health Continuum - Short Form (MHC-SF). (To be completed by RAC direct-care participants.)
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Assessment method [2]
385962
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Timepoint [2]
385962
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Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
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Secondary outcome [3]
385963
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Changes in quality of life as measured by the Australian Quality of Life - 4D (AQOL-4D). (To be completed by RAC direct-care participants.)
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Assessment method [3]
385963
0
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Timepoint [3]
385963
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Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
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Secondary outcome [4]
385964
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Changes in perceptions of workplace psychosocial risk factors as measured by the Copenhagen Psychosocial Questionnaire - II (COPSOQ-II). (To be completed by RAC direct-care participants.)
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Assessment method [4]
385964
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Timepoint [4]
385964
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Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
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Secondary outcome [5]
385966
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Changes in the perceptions of workplace psychosocial risk factors as measured by the People at Work Survey - bullying module (PAW). (To be completed by RAC direct-care participants.)
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Assessment method [5]
385966
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Timepoint [5]
385966
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Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
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Secondary outcome [6]
385967
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Usability and accessibility of the digital tool (WWA) as measured by the System Usability Scale (SUS). (To be completed by RAC direct-care and manager participants.)
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Assessment method [6]
385967
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Timepoint [6]
385967
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2 weeks after first login to (WWA) the digital tool.
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Secondary outcome [7]
385968
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Semi-structured interviews designed specifically for the study to determine qualitative views of using WWA. (To be completed by RAC direct-care and manager participants. Up to 15 interviews will be conducted (five managers and ten direct-care staff.)
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Assessment method [7]
385968
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Timepoint [7]
385968
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12 weeks post commencement of the intervention.
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Secondary outcome [8]
385971
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Changes in wellbeing following use of WWA as measured by an Intervention Satisfaction Questionnaire designed specifically for the study. (To be completed by RAC direct-care and manager participants.)
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Assessment method [8]
385971
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Timepoint [8]
385971
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24 weeks post commencement of the intervention.
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Eligibility
Key inclusion criteria
Inclusion criteria to be eligible to participate in the study are as follows:
• Direct-care staff employed on a permanent full-time or part-time basis in RAC facilities where at least one manager has also agreed to participate. (WWA requires the active participation from one RACS manager with a minimum of five direct-care staff per site for site participation.)
• Managers employed on a permanent full-time or part-time basis in a RAC facility.
• Participants must be 18 years or older and able to provide informed consent.
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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
Those not eligible to participate in the study will include the following:
• Staff not employed with a RAC facility.
• Casual staff employed within a RAC facility.
• Staff who have not provided consent.
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Study design
Purpose of the study
Prevention
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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
Efficacy
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Statistical methods / analysis
GPower (3.1) was used to calculate the sample size required. The test was based on a repeated measure within factors design, one group across 3 measurement administrations with a correlation amongst repeated measures of 0.7. Typically, effect size change for targeted digital mental health tools / programs is between .50 - .80. However, given that WWA is new and something similar has not yet been evaluated, a very conservative small effect size change of 0.15 (f-test) was used.
Assuming a conservative small effect (i.e. GPower f test = 0.15), significance set at 5% (p = .05), power at 80%, a sample of 46 will be required to demonstrate statistical significance on the primary outcome measure (Psychosocial Safety Climate [PSC-12]). However, allowing for a 50% attrition rate, we will be required to recruit N=92 participants.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/10/2020
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Actual
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Date of last participant enrolment
Anticipated
30/10/2020
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Actual
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Date of last data collection
Anticipated
14/05/2021
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Actual
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Sample size
Target
92
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Accrual to date
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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]
303739
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Government body
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Name [1]
303739
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WorkSafe - WorkSafe WorkWell Mental Health Improvement Fund
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Address [1]
303739
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WorkSafe Head Office: 1 Malop Street, Geelong Victoria 3220
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Country [1]
303739
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Prevention United
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Address
552 Victoria Street, North Melbourne VIC 3051
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Country
Australia
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Secondary sponsor category [1]
303858
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University
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Name [1]
303858
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Federation University Australia
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Address [1]
303858
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University Drive, Mt Helen VIC 3350
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Country [1]
303858
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Australia
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Secondary sponsor category [2]
307037
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Government body
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Name [2]
307037
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Ballarat Health Services - Residential Aged Care Services
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Address [2]
307037
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907 Sturt Street, Ballarat VIC 3350
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Country [2]
307037
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304271
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Ballarat Health Services & St John of God Hospital Ballarat Human Research Ethics Committee
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Ethics committee address [1]
304271
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PO Box 577, Drummond Street North, Ballarat, Victoria, 3350
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Ethics committee country [1]
304271
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Australia
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Date submitted for ethics approval [1]
304271
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13/04/2020
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Approval date [1]
304271
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15/09/2020
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Ethics approval number [1]
304271
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60926
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Summary
Brief summary
The aim of this project is to develop and evaluate whether a digital monitoring and support tool, called Workplace Wellbeing Assist (WWA), is effective in promoting a workplace climate that enhances the mental wellbeing of direct-care staff working at Residential Aged Care facilities in Victoria, Australia (Western Division). Direct-care workers and managers will be invited to participate in a 24-week evaluation of WWA. The study is a non-randomised, pre-mid-post study design, including validated questionnaires and interviews. Specifically, this project seeks to: 1. Determine whether WWA increases perceptions of psychosocial safety in the workplace among consenting residential aged care staff as measured by differences on the Psychosocial Safety Climate questionnaire from Baseline (week 0), to mid (week 12), to post-intervention (week 24). 2. Determine whether WWA can successfully promote staff mental wellbeing and quality of life, and reduce psychological distress and workplace psychosocial risk factors as measured by differences in a pre-mid-post trial. 3. Use quantitative and qualitative evaluation trial data, to further explore the acceptability, usability and usefulness of WWA and allow for future optimisation of WWA for the residential aged care sector. The results of this research will be used to determine whether a digital intervention can effectively promote a mentally healthy workplace that enhances staff mental wellbeing within Residential Aged Care facilities and how it could potentially be optimised for other workplaces.
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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
96334
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Prof Britt Klein
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Address
96334
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Federation University Australia, University Drive, Mount Helen, VIC 3350
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Country
96334
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Australia
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Phone
96334
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+61 3 5327 6717
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Fax
96334
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Email
96334
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[email protected]
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Contact person for public queries
Name
96335
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Wendi Kruger
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Address
96335
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Federation University Australia, Building O, SMB Campus, Lydiard Street South, Ballarat, VIC 3350
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Country
96335
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Australia
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Phone
96335
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+61 3 5327 6524
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Fax
96335
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Email
96335
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[email protected]
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Contact person for scientific queries
Name
96336
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Britt Klein
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Address
96336
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Federation University Australia, University Drive, Mount Helen, VIC 3350
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Country
96336
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Australia
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Phone
96336
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+61 3 5327 6717
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Fax
96336
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Email
96336
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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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