Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000420741
Ethics application status
Approved
Date submitted
28/03/2013
Date registered
15/04/2013
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Staff as Change Agents – Sustaining Mental Health in Aged Care
Scientific title
A randomised controlled trial evaluating the effects of staff training in the use of mental health tools and psychosocial strategies for depression and challenging behaviours associated with dementia (BPSD) on care staff and care recipients in residential aged care.
Secondary ID [1] 282340 0
None
Universal Trial Number (UTN)
U1111-1141-0109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventative and screening interventions of depression 288712 0
Assessment and managing interventions for challenging behaviours associated with dementia 288713 0
Staff knowledge and skills to manage mental health protocols associated with depression and challenging behaviours associated with dementia 288714 0
Workplace climate factors of trust, effective communication, teamwork and cohesion 288715 0
Staff factors such as stress, job satisfaction and staff turnover 288716 0
Condition category
Condition code
Mental Health 289043 289043 0 0
Depression
Neurological 289044 289044 0 0
Dementias
Public Health 289064 289064 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1
The training with 6-10 senior care staff involves 5 sessions over 11 weeks. Session 1, 2 and 3 are run one week apart. Session 4 is 4 weeks after session 3 and the booster session is run 4 weeks after session 4.
Session 1: Depression and Workplace Environment looks at screening, communication, referral and workplace strengths and challenges (2 hours)
Session 2: Challenging Behaviours looks at possible causes, and an Assessment and Management Tool for Staff (2 hours)
Session 3: Staff as Change Agents looks at key characteristics and behaviours for facilitating change (2 hours)
Session 4: Sustaining Mental Health in Aged Care looks at how to develop a workplace environment framework that supports mental health protocols (2 hours)
Booster Session: The content and activity will be driven by each individual facility’s needs, with the aim being to provide additional support and practice for the team leaders and participants driving the new initiatives (1.5 hours)

Intervention 2
The training will run exactly the same as in intervention 1. Once training is complete and care staff have completed their post-training questionnaires, a clinical psychologist, provided by the research project, will be situated with each facility for approximately one day per week for a six month period. Their role will be to provide clinical support to care staff to assist them with the roll out of the strategy to better recognise and manage depression and BPSD among care recipients.


Intervention code [1] 286788 0
Early detection / Screening
Intervention code [2] 286930 0
Treatment: Other
Comparator / control treatment
Over approximately 12 months facilities in the control group will participate in the research project and complete all the staff and resident measures and without staff training or additional clinical support. After all the measures are complete care staff will participate in the training program as outlined in Intervention 1.
Control group
Active

Outcomes
Primary outcome [1] 289154 0
Care Staff: Measuring management support, change efficacy, personal benefit and appropriateness using the 'Organisational Readiness Factors' scale containing 25 items. This will be administered along with the other secondary staff measures.
Timepoint [1] 289154 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Primary outcome [2] 289312 0
Care Residents: Severity of BPSD using the 'Cohen-Mansfield Agitation Inventory'
Timepoint [2] 289312 0
Time 1: Baseline resident measures completed before staff time 1 measures. Time 2: 6 months after time 1. Time 3: 12 months after time 1.
Primary outcome [3] 289313 0
Care Residents: Severity of depression using the 'Cornell Scale for Depression'
Timepoint [3] 289313 0
Time 1: Baseline resident measures completed before staff time 1 measures. Time 2: 6 months after time 1. Time 3: 12 months after time 1.
Secondary outcome [1] 301942 0
Residents: Depression referral rates recorded
Timepoint [1] 301942 0
Baseline resident measures completed before staff time 1 measures and bi-monthly for 12 months.
Secondary outcome [2] 302217 0
Residents: Management of depression and BPSD by reviewing residents' files
Timepoint [2] 302217 0
Baseline resident measures completed before staff time 1 measures and bi-monthly for 12 months.
Secondary outcome [3] 302218 0
Staff skills and knowledge as assessed by the 'Knowledge of Depression Scale Revised'
Timepoint [3] 302218 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [4] 302219 0
Measuring staff confidence with 'Confidence in Working with Depressed Older People Scale'
Timepoint [4] 302219 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [5] 302220 0
Measuring self-efficacy of care staff with 'Self-efficacy in Working with Dementia Scale'
Timepoint [5] 302220 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [6] 302221 0
Measuring care staff stress in 'Strains in Nursing Care Scale'
Timepoint [6] 302221 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [7] 302222 0
Measuring emotional well-being, job satisfaction, supervisory support, views and intention in 'Work Environment Questionnaire'
Timepoint [7] 302222 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [8] 302223 0
Measuring workplace climate in 'Organisational Climate Questionnaire'
Timepoint [8] 302223 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [9] 302224 0
Measuring quality of workplace and staff communication in 'Communication Scale'
Timepoint [9] 302224 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [10] 302225 0
Measuring staff workplace behaviours and performance in 'Transformational/Transactional Items'
Timepoint [10] 302225 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).
Secondary outcome [11] 302226 0
Measuring staff trust in the workplace in 'Trust Scale'
Timepoint [11] 302226 0
Time 1: 1 week before session 1 (intervention). Time 2: at the end of the session 5 (intervention). Time 3: 6 months after session 5 (post-intervention). Time 4: 12 months after session 5 (post-intervention).

Eligibility
Key inclusion criteria
Participants - organisation: An aged care facility in Victoria with a minimum of 60 beds.

Participants - staff: Leadership team and senior RNs and senior PCAs.

Participants - residents: A score of 8 and above on the Cornell Scale for Depression in Dementia, or with challenging behaviours associated with BPSD.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents without depression or dementia are excluded and residents with both depression and dementia are excluded.

Junior staff and staff not competent in English are excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
For analysis of differences in facilities at baseline, analysis of variance will be used, with Fisher’s Exact test for analysing categorical variables. For changes over time, repeated measures multiple analysis of covariance (MANCOVA; controlling for group baseline scores on outcome measures) will be used for our continuous measures associated with staff outcomes. Longitudinal Configural Frequency Analysis (CFA) will be used to analyse change in categorical variables such as number of depression and BPSD referrals prior, immediate post training, at 6-month and at 12-month training follow-up. CFA is a technique analogous to repeated measures MANCOVA that allows for the estimation of trends and group differences over time but for categorical variables. Allowing for a 20% attrition rate – a rate of attrition common in our past studies – we have calculated that we will maintain at least 28 staff and 96 residents per condition at 12-month follow-up. Based on our estimated sample size in each of the conditions at 12-month follow-up, and with the expectation of a small-to-moderate effect size d = .20, the power of the analyses for aged care resident data is calculated at 0.99, and for the staff data at .91 at the two-sided significance level of a = .05 for both our mean difference testing and categorical analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
13/03/2013
Date of last participant enrolment
Anticipated
19/12/2014
Actual
22/07/2014
Date of last data collection
Anticipated
Actual
12/10/2015
Sample size
Target
468
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286948 0
Government body
Name [1] 286948 0
National Health and Medical Research Council (NHMRC)
Country [1] 286948 0
Australia
Primary sponsor type
Individual
Name
Professor Marita McCabe
Address
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood
Victoria 3151
Country
Australia
Secondary sponsor category [1] 285735 0
Individual
Name [1] 285735 0
Professor David Mellor
Address [1] 285735 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood
Victoria 3151
Country [1] 285735 0
Australia
Secondary sponsor category [2] 285748 0
Individual
Name [2] 285748 0
Dr Tanya Davison
Address [2] 285748 0
Aged Mental Health Research Unit
School of Psychology & Psychiatry
Monash University
Kingston Centre
Warrigal Road
Cheltenham, VIC 3192
Country [2] 285748 0
Australia
Secondary sponsor category [3] 285749 0
Individual
Name [3] 285749 0
Dr Gery Karantzas
Address [3] 285749 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood
Victoria 3151
Country [3] 285749 0
Australia
Secondary sponsor category [4] 285750 0
Individual
Name [4] 285750 0
Dr Kathryn Von Treuer
Address [4] 285750 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood
Victoria 3151
Country [4] 285750 0
Australia
Secondary sponsor category [5] 285751 0
Individual
Name [5] 285751 0
Professor Daniel O'Connor
Address [5] 285751 0
Aged Mental Health Research Unit
School of Psychology & Psychiatry
Monash University
Kingston Centre
Warrigal Road
Cheltenham, VIC 3192
Country [5] 285751 0
Australia
Secondary sponsor category [6] 285752 0
Individual
Name [6] 285752 0
Mrs Anastasia Konis
Address [6] 285752 0
School of Psychology
Faculty of Health
Deakin University
221 Burwood Highway
Burwood
Victoria 3151
Country [6] 285752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289001 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 289001 0
Ethics committee country [1] 289001 0
Australia
Date submitted for ethics approval [1] 289001 0
16/01/2013
Approval date [1] 289001 0
15/02/2013
Ethics approval number [1] 289001 0
2013-013

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

Contacts
Principal investigator
Name 38734 0
Prof Marita McCabe
Address 38734 0
School of Psychology, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Victoria 3151
Country 38734 0
Australia
Phone 38734 0
+61 3 924 46856
Fax 38734 0
Email 38734 0
[email protected]
Contact person for public queries
Name 38735 0
Marita McCabe
Address 38735 0
School of Psychology, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Victoria 3151
Country 38735 0
Australia
Phone 38735 0
+61 3 924 46856
Fax 38735 0
Email 38735 0
[email protected]
Contact person for scientific queries
Name 38736 0
Marita McCabe
Address 38736 0
School of Psychology, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, Victoria 3151
Country 38736 0
Australia
Phone 38736 0
+61 3 924 46856
Fax 38736 0
Email 38736 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


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.