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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.
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.
Secondary ID [1] 302385 0
None
Universal Trial Number (UTN)
U1111-1239-8969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace mental wellbeing
 314299 0
Condition category
Condition code
Public Health 312656 312656 0 0
Health promotion/education
Mental Health 313965 313965 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315495 0
Prevention
Intervention code [2] 318433 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324856 0
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.)
Timepoint [1] 324856 0
Baseline, 12 weeks (primary timepoint), and 24 weeks post commencement of the intervention.
Secondary outcome [1] 385959 0
Changes in psychological distress as measured by the Kessler Psychological Distress Scale (K10). (To be completed by RAC direct-care participants.)
Timepoint [1] 385959 0
Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
Secondary outcome [2] 385962 0
Changes in mental wellbeing as measured by the Mental Health Continuum - Short Form (MHC-SF). (To be completed by RAC direct-care participants.)
Timepoint [2] 385962 0
Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
Secondary outcome [3] 385963 0
Changes in quality of life as measured by the Australian Quality of Life - 4D (AQOL-4D). (To be completed by RAC direct-care participants.)
Timepoint [3] 385963 0
Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
Secondary outcome [4] 385964 0
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.)
Timepoint [4] 385964 0
Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
Secondary outcome [5] 385966 0
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.)
Timepoint [5] 385966 0
Baseline, 12 weeks, and 24 weeks post commencement of the intervention.
Secondary outcome [6] 385967 0
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.)
Timepoint [6] 385967 0
2 weeks after first login to (WWA) the digital tool.
Secondary outcome [7] 385968 0
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.)
Timepoint [7] 385968 0
12 weeks post commencement of the intervention.
Secondary outcome [8] 385971 0
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.)
Timepoint [8] 385971 0
24 weeks post commencement of the intervention.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2020
Actual
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
14/05/2021
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303739 0
Government body
Name [1] 303739 0
WorkSafe - WorkSafe WorkWell Mental Health Improvement Fund
Country [1] 303739 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Prevention United
Address
552 Victoria Street, North Melbourne VIC 3051
Country
Australia
Secondary sponsor category [1] 303858 0
University
Name [1] 303858 0
Federation University Australia
Address [1] 303858 0
University Drive, Mt Helen VIC 3350
Country [1] 303858 0
Australia
Secondary sponsor category [2] 307037 0
Government body
Name [2] 307037 0
Ballarat Health Services - Residential Aged Care Services
Address [2] 307037 0
907 Sturt Street, Ballarat VIC 3350
Country [2] 307037 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304271 0
Ballarat Health Services & St John of God Hospital Ballarat Human Research Ethics Committee
Ethics committee address [1] 304271 0
Ethics committee country [1] 304271 0
Australia
Date submitted for ethics approval [1] 304271 0
13/04/2020
Approval date [1] 304271 0
15/09/2020
Ethics approval number [1] 304271 0
60926

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96334 0
Prof Britt Klein
Address 96334 0
Federation University Australia, University Drive, Mount Helen, VIC 3350
Country 96334 0
Australia
Phone 96334 0
+61 3 5327 6717
Fax 96334 0
Email 96334 0
b.klein@federation.edu.au
Contact person for public queries
Name 96335 0
Wendi Kruger
Address 96335 0
Federation University Australia, Building O, SMB Campus, Lydiard Street South, Ballarat, VIC 3350
Country 96335 0
Australia
Phone 96335 0
+61 3 5327 6524
Fax 96335 0
Email 96335 0
w.kruger@federation.edu.au
Contact person for scientific queries
Name 96336 0
Britt Klein
Address 96336 0
Federation University Australia, University Drive, Mount Helen, VIC 3350
Country 96336 0
Australia
Phone 96336 0
+61 3 5327 6717
Fax 96336 0
Email 96336 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.