Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001158853
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
27/08/2021
Date last updated
16/12/2022
Date data sharing statement initially provided
27/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of the Work4Dementia program to enhance capacity and resilience of the Australian dementia care workforce
Scientific title
A waitlist-controlled pilot trial of the Work4Dementia intervention to build capacity and resilience for the Australian dementia care workforce
Secondary ID [1] 302173 0
NHMRC E0023237
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 318831 0
resilience 318832 0
Condition category
Condition code
Mental Health 316839 316839 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 319706 319706 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Work4Dementia intervention is a new training intervention for the aged and dementia care workforce that includes both organisational and employee based components. Work4Dementia has been designed specifically for this study using co-design principles and is described in a facilitator guidebook. The content has been informed by positive psychology, focused on personal and organisational strengths and growth. The whole of the Work4Dementia program will be delivered online by a trained facilitator over six weeks. The organisational component of the intervention includes i) management orientation (15 minute welcome video + 15 minute change readiness assessment + 2 x 30 minute meetings over the first two weeks), and ii) allocation of a workplace champion and iii) mentor support (4 x 30 minute meetings between champion and facilitator to address actions raised by the shared practice group over the final four weeks). The role of the workplace champion is to undertake essential communication between multiple stakeholders within the organisation to promote building capacity and resilience in care work. A detailed position description on the role of the champion is included in the facilitator guidebook. The employee component is called the ‘shared practice group’ (4 x 1.5 hours weekly group meetings with maximum of 30 care workers per session) and begins in week three (after the orientation). Adult learning principles will be applied. Mode of delivery is interactive activities, short videos, stress and coping strategies, with handout materials summarising key points that provide skills to practice in between sessions. The topics covered include capacity and resilience in care work, understanding dementia and communication, the power of social connections and coping with emotionally demanding jobs.
Intervention code [1] 320573 0
Lifestyle
Intervention code [2] 321360 0
Behaviour
Comparator / control treatment
A waitlist-controlled pilot trial will be run which will include the control group as treatment as usual that will be existing workforce development programs, then followed by completing the Work4Dementia intervention. The control group will be offered the Work4Dementia intervention eight weeks post enrolment.
Control group
Active

Outcomes
Primary outcome [1] 327550 0
Acceptability and feasibility are a composite primary outcome measure which is assessed quantitatively by audit of study enrolment logs on recruitment and retention of participants (e.g., number of refusals, withdrawals, attendance), time commitments of participants and economic costs of delivery(e.g., number of hours to complete all activities by reviewing the detailed facilitator guidebook).
Timepoint [1] 327550 0
Baseline, 1,2,3,4,5,6 (primary endpoint after completion of work4Dementia) and 8 weeks post enrolment (or 2 weeks follow up after the intervention).
Primary outcome [2] 327551 0
Acceptability and feasibility area a composite primary outcome measure assessed by collection of qualitative data through audio-recorded individual semi-structured interviews (approximately 30 minutes) per participant group - care workers, care managers, care recipients and or their family members/support persons). Questions addressing suitability (perceived enablers and barriers to the intervention) and satisfaction with content and delivery style of the intervention will be covered.
Timepoint [2] 327551 0
After the completion of the Work4Dementia intervention at 6 weeks.
Primary outcome [3] 327552 0
Treatment fidelity checklists, which were designed for each employee shared practice group session (1-4) as per the facilitator guidebook, as based on Walton et al (2019) fidelity checklist used for the PRIDE intervention.

Walton, H., Spector, A., Williamson, M., Tombor, I., & Michie, S. (2019). Developing quality fidelity and engagement measures for complex health interventions. Br J Health Psychol. doi:10.1111/bjhp.12394
Timepoint [3] 327552 0
Facilitator to complete after each employee shared practice group session, 1,2,3,4 in weeks 2,3,5,6 post intervention commencement.
Secondary outcome [1] 395626 0
Organisational readiness measured by Organisational Change Questionnaire
Timepoint [1] 395626 0
weeks 1, 3, 4, 6, 8 post intervention commencement
Secondary outcome [2] 395627 0
Psychological distress of employees measured by Kessler Psychological Distress Scale 6 item
Timepoint [2] 395627 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [3] 395628 0
Positive and negative affect of employees measured by Positive and Negative Affect Scale
Timepoint [3] 395628 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [4] 395629 0
Employees satisfaction with life measured by Satisfaction with Life Scale
Timepoint [4] 395629 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [5] 395630 0
Employees job satisfaction measured by 3 items by Warr et al, 1979
Timepoint [5] 395630 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [6] 395631 0
Employees occupational self-efficacy measured by Short Occupational Self Efficacy Scale
Timepoint [6] 395631 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [7] 395632 0
Employees psychological capital measured by Psychological Capital Questionnaire
Timepoint [7] 395632 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [8] 395633 0
Employees work engagement measured by Utrecht Work Engagement Scale
Timepoint [8] 395633 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [9] 395634 0
Employees occupational communion measured by Occupational Communion Scale
Timepoint [9] 395634 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [10] 395635 0
Employee turnover intentions measured by Intention to Stay/Leave
Timepoint [10] 395635 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [11] 395636 0
Employee dementia knowledge measured by Dementia Knowledge Assessment Scale
Timepoint [11] 395636 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [12] 395691 0
Care recipient quality of life measured by Quality of Life-Alzheimer's Disease Scale (self-report and proxy report)
Timepoint [12] 395691 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [13] 395692 0
Care recipient capabilities, care needs and social care related quality of life as measured by the Australian Community Care Outcomes Measure
Timepoint [13] 395692 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [14] 395693 0
Satisfaction with staff as measured by Client Satisfaction: Home Care completed by care recipients and their family members/support person
Timepoint [14] 395693 0
weeks 1, 3, 6, 8 post intervention commencement
Secondary outcome [15] 400178 0
This is Primary outcome 3- Acceptability and feasibility area a composite primary outcome measure assessed by collection of qualitative data collected through audio-recorded focus group discussions (with maximum of 30 people and approximately 30 minutes) per participant group - care workers, care managers, care recipients and or their family members/support persons). Questions addressing suitability (perceived enablers and barriers to the intervention) and satisfaction with content and delivery style of the intervention will be covered.
Timepoint [15] 400178 0
After the completion of the Work4Dementia intervention at 6 weeks.

Eligibility
Key inclusion criteria
Organisations- providing aged care services in Australia
Managers- 1) currently employed by one of the aged care organisation participating in the trial; 2) currently employed in a managerial role (responsible for operation and supervision of staff)
Care workers- 1) currently employed by one of the aged care organisation participating in the trial; 2) currently providing care or support to older people with and/or without dementia in their work role
Care recipients- 1) aged 65 years or older; 2) currently receiving care or support from the participating organisation; 3) currently receiving care from one of the care workers participating in the intervention
Support people for care recipients- 1) someone who provides informal support (such as a family member or friend) to a care recipient who is participating in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Managers and care workers- 1) persons under the aged of 18 years; 2) people highly dependent on medical care or unable to give consent; 3) people whose English language skills preclude them from completing the intervention and participating in an interview
Care recipients- 1) people whose English language skills preclude them from participating in an interview; 2) people with a speech or hearing impairment or level of cognitive impairment that will prevent them from participating in an interview
Support people for care recipients- 1) persons under the aged of 18 years; 2) people highly dependent on medical care or unable to give consent; 3) people whose English language skills preclude them from participating in a focus group discussion; 4) people with a speech or hearing impairment or level of cognitive impairment that will prevent them from participating in an interview

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed due to difficulties with cluster randomization of each organisation rather than each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be applied using the coin-toss procedure. Organisations will be randomly allocated to undertake either the Work4Dementia intervention immediately or a control period of usual care (i.e., existing workforce development programs) followed by undertaking the Work4Dementia intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To assess acceptability and feasibility, qualitative data from interviews and focus groups will be analysed using a thematic analysis approach.
Treatment fidelity will be analysed by calculating percentage adherance for each session.
Preliminary analysis will be conducted on intervention efficacy. Analysis will include a 2 intervention (Work4Dementia, usual care) by 4 group (managers, employees, care recipients and support people) by 4 time (baseline, pre, post, 1 month follow-up) repeated measures factorial design, employed to assess main and interaction effects (MANCOVAs with baseline level ANCOVAs performed to control for confounding factors). The preliminary analysis will have small to moderate power to determine efficacy. As such, Reliable Change Index (RCI) scores will be calculated to assess intervention impact.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2021
Actual
7/03/2022
Date of last participant enrolment
Anticipated
20/03/2022
Actual
13/05/2022
Date of last data collection
Anticipated
31/08/2022
Actual
1/08/2022
Sample size
Target
190
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306597 0
Government body
Name [1] 306597 0
National Health and Medical Research Council and Australian Research Council
Country [1] 306597 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Private Bag 143 Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 309503 0
None
Name [1] 309503 0
Address [1] 309503 0
Country [1] 309503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306782 0
Tasmania Health and Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 306782 0
Ethics committee country [1] 306782 0
Australia
Date submitted for ethics approval [1] 306782 0
29/06/2020
Approval date [1] 306782 0
23/08/2021
Ethics approval number [1] 306782 0
H0021893

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

Contacts
Principal investigator
Name 105002 0
Dr Kate-Ellen Elliott
Address 105002 0
University of Tasmania Private Bag 30, Hobart, TAS, 7001
Country 105002 0
Australia
Phone 105002 0
+61 362262657
Fax 105002 0
Email 105002 0
[email protected]
Contact person for public queries
Name 105003 0
Kate-Ellen Elliott
Address 105003 0
University of Tasmania Private Bag 30, Hobart, TAS, 7001
Country 105003 0
Australia
Phone 105003 0
+61 362262657
Fax 105003 0
Email 105003 0
[email protected]
Contact person for scientific queries
Name 105004 0
Kate-Ellen Elliott
Address 105004 0
University of Tasmania Private Bag 30, Hobart, TAS, 7001
Country 105004 0
Australia
Phone 105004 0
+61 362262657
Fax 105004 0
Email 105004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure participant confidentiality, the results will be provided in a collective format. Specific data about individual participants will not be made publicly available and will not be reported or returned to individuals or participating care organisations.


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.