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Trial registered on ANZCTR


Registration number
ACTRN12618000241235
Ethics application status
Approved
Date submitted
7/02/2018
Date registered
14/02/2018
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Date results information initially provided
24/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a wellbeing clinic to support older adults with mild to moderate dementia living in residential aged care settings
Scientific title
Evaluating a wellbeing clinic to support older adults with mild to moderate dementia living in residential aged care settings
Secondary ID [1] 293976 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 306489 0
Depression 306490 0
Anxiety 306493 0
Condition category
Condition code
Neurological 305588 305588 0 0
Dementias
Mental Health 305590 305590 0 0
Depression
Mental Health 305591 305591 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention condition involving the Wellbeing Clinic is tri-focal.
First, up to 20 face-to-face sessions (30 - 50 minutes each session, once a week approximately) will be provided to residents on a one-on-one basis by mental health trainees. Consistent with evidence based protocols for improving mood in older adults with dementia (Meeks et al., 2008; Stanley et al., 2013), family caregivers and/or staff will be invited to attend approximately 50% of these sessions. Interventions will include behavioural strategies for improving mood, relaxation techniques for reducing anxiety, cognitive strategies for modifying unhelpful automatic beliefs and reminiscence strategies for priming valued self-representations and memories. Interventions will be matched to residents’ goals and cognitive capacity. The intervention protocol is formalized within a treatment manual, and is based on the works of Meeks et al, Stanley et al., and Bhar (2017).

Second, a structured training and support program will be provided to family caregivers. A 2-hour training program will be co-designed by AAV, SUT and the steering committee to provide family caregivers with an understanding of dementia and of methods for interacting positively with the care recipient. In addition, family caregivers will be invited to join a caregiver support group program, held monthly for 2 hours each month, for 6 months, at the facility, which will provide further support to reduce caregiver distress and improve their sense of competency in interacting with their family members living with dementia. The support group program is based on narrative and normative practices, and is formalized by a program protocol. The training workshop is designed by Dementia Australia. The workshop is described in https://www.dementia.org.au/learning/centre-for-dementia-learning/edie-educational-dementia-immersive-experience.

Third, a 3-hour workshop will be provided on-site to facility staff, designed to improve staff knowledge about dementia and competence in interacting with residents living with dementia. This workshop is designed by Dementia Australia, as described in https://www.dementia.org.au/learning/centre-for-dementia-learning/edie-educational-dementia-immersive-experience.
Intervention code [1] 300248 0
Treatment: Other
Intervention code [2] 300249 0
Lifestyle
Intervention code [3] 300250 0
Behaviour
Comparator / control treatment
The control group will involve the Victorian based UA facilities and affiliates to continuing their usual practices
Control group
Active

Outcomes
Primary outcome [1] 304708 0
Change in levels of depression as measured by the Cornell Scale for Depression in Dementia (CSDD)
Timepoint [1] 304708 0
Data will be collected at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline). The primary endpoint is 6 months post baseline.
Primary outcome [2] 304709 0
Anxiety levels as measured by the Rating Anxiety in Dementia Scale (RAID)
Timepoint [2] 304709 0
Data will be collected at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline). he primary endpoint is 6 months post baseline.
Secondary outcome [1] 342900 0
Carer Burden as measured by the Zarit Burden Interview (Short form) (ZBI-12)
Timepoint [1] 342900 0
Questionnaire data will be collected from caregivers at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [2] 342901 0
Staff's confidence in supporting the resident with dementia measured using the sense of competence in Dementia Staff Scale (SCIDS)
Timepoint [2] 342901 0
Questionnaire data will be collected from staff at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [3] 342902 0
Self-efficacy of carer as measured with the RIS elder care self-efficacy scale) (RIS)
Timepoint [3] 342902 0
Questionnaire data will be collected from carergivers at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [4] 342906 0
Carer reactions to symptoms of dementia as measured by the The Revised Memory and Behavior Problems Checklist) (RMBPC)
Timepoint [4] 342906 0
Questionnaire data will be collected from carergivers at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [5] 342908 0
Staff reactions to symptoms of dementia as measured by the The Revised Memory and Behavior Problems Checklist) (RMBPC)
Timepoint [5] 342908 0
Questionnaire data will be collected from staff at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [6] 342909 0
Staff attitudes about dementia as measured using the Dementia Attitudes Scale (DAS)
Timepoint [6] 342909 0
Questionnaire data will be collected from staff at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).
Secondary outcome [7] 342924 0
Residents’ quality of life as measured by resident and informant using Quality of Life –Alzheimer’s Disease Scale- Nursing Home version (QOL-AD-NH)
Timepoint [7] 342924 0
Data will be collected at baseline, at post-treatment (6 months post-baseline) and at follow-up (9 months post baseline).

Eligibility
Key inclusion criteria
Residents are eligible to participate if they:
1. are currently 65 years or older.
2. are currently living in residential aged care facilities
3. are diagnosed with dementia (major neurocognitive disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition [DSM 5]),
4. have within the six months been found to have mild to moderate cognitive impairment as defined as a score between 24 and 10 on the mini-mental state examination (MMSE) or the equivalent on the Psychogeriatric Assessment Scale Cognitive Impairment Scale (PAS-CIS) – 4 to 15 inclusive
5. have within the past year been found to have clinically significant levels of depression as indicated by a minimum of 7 on the Cornell Scale for Depression in Dementia (CSDD) or 11 on the Rating Anxiety in Dementia (RAID)

Family/friend caregivers will be eligible to participate if they are
1. nominated by the resident or legal proxy as an important source of care for the resident
2. are at least 18 years old, and
3. can communicate in English
4. willing to participate in project activities


Facility staff will be eligible to participate if they are
1. nominated by the resident, legal proxy or unit manager/clinical as an important source of care for the resident
2. are at least 18 years old, and
3. can communicate in English
4. willing to participate in project activities
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents with limited capacity to communicate verbally in English (due to a lack of English language proficiency as assessed by facility or research staff) or who are unable to complete study procedures due to health conditions (e.g., resident is physically unwell, highly distressed)(as assessed by facility or research staff) will not be eligible to participate in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation schedules will be remotely and independently constructed by a statistician independent to the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster-randomized trial design will be utilized for this project. Twelve UA residential aged care facilities (RACFs) will be evenly allocated at random to an intervention condition (6 sites) or to the control (usual care) condition (6 sites).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 18793 0
3128 - Box Hill
Recruitment postcode(s) [2] 18794 0
3124 - Camberwell
Recruitment postcode(s) [3] 18795 0
3101 - Kew
Recruitment postcode(s) [4] 18796 0
3186 - Brighton
Recruitment postcode(s) [5] 18797 0
3216 - Belmont
Recruitment postcode(s) [6] 18798 0
3012 - Kingsville
Recruitment postcode(s) [7] 18799 0
3024 - Wyndham Vale
Recruitment postcode(s) [8] 18800 0
3174 - Noble Park
Recruitment postcode(s) [9] 18801 0
3550 - Bendigo
Recruitment postcode(s) [10] 18802 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 298609 0
Government body
Name [1] 298609 0
Deparment of Health
Address [1] 298609 0
GPO Box 9880
Canberra ACT 2601
Country [1] 298609 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Sunil Bhar
Address
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Country
Australia
Secondary sponsor category [1] 297768 0
None
Name [1] 297768 0
Address [1] 297768 0
Country [1] 297768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299568 0
Swinburne University Human Research Ethics
Ethics committee address [1] 299568 0
Research Ethics Office
Swinburne Research (H68)
Swinburne University of Technology
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 299568 0
Australia
Date submitted for ethics approval [1] 299568 0
Approval date [1] 299568 0
08/01/2018
Ethics approval number [1] 299568 0

Summary
Brief summary
This project evaluates an innovative model involving the delivery of psychological interventions by mental health trainees (MHTs) to residents with mild to moderate dementia. Interventions are provided to residents over 6 months (approximately 20 face-to-face sessions). Training in understanding dementia is also provided to their caregivers (family and friends) and to facility staff. In addition, caregivers are invited to join a monthly support group. Hence, the treatment involves a systemic approach involving residents, their caregivers and facility staff. Using a cluster-randomised controlled trial, this project compares the effectiveness of the model over and above usual practice, for improving depression and anxiety levels in residents with dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80866 0
Prof Sunil Bhar
Address 80866 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 80866 0
Australia
Phone 80866 0
+61 3 9214 8371
Fax 80866 0
Email 80866 0
sbhar@swin.edu.au
Contact person for public queries
Name 80867 0
Prof Sunil Bhar
Address 80867 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 80867 0
Australia
Phone 80867 0
+61 3 9214 8371
Fax 80867 0
Email 80867 0
sbhar@swin.edu.au
Contact person for scientific queries
Name 80868 0
Prof Sunil Bhar
Address 80868 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 80868 0
Australia
Phone 80868 0
+61 3 9214 8371
Fax 80868 0
Email 80868 0
sbhar@swin.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
I do not believe the study sponsor will allow this.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary