COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000393954
Ethics application status
Approved
Date submitted
10/03/2020
Date registered
23/03/2020
Date last updated
23/03/2020
Date data sharing statement initially provided
23/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between quality of life , cognitive function and sedative medications that older people with dementia regularly consume.
Scientific title
Psychotropic medications in older people in residential care facilities and associations with
quality of life and cognitive impairment: a cross-sectional sub-study

Secondary ID [1] 300745 0
None
Universal Trial Number (UTN)
U1111-1249-4179
Trial acronym
CSS
Linked study record
Main study : ACTRN12620000268943

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 316583 0
Dementia 316584 0
Condition category
Condition code
Mental Health 314816 314816 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 314921 314921 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
This substudy will determine the independent association between quality of life (QoL), the cognitive state and psychotropic medications among older adults with dementia. This will be based on the data collected from 200 participants from the baseline for a randomised trial.
This sub-study will focus on the relationship between cognitive deterioration and the use of psychotropic drugs in a nursing home setting. Standardised Mini-Mental State Examination (SMMSE) will be used as a screening test for the purpose of evaluating cognitive impairment in older adults.
The estimated sample size for this substudy is 200 participants. All participants are voluntary, and they can withdraw at any time without any reason. The researcher will first arrange consent with the residential aged care facility (RACF), then participants will be either consented to be part of the study or a proxy (a close family member) will provide consent on their behalf if the participant has moderate to severe cognitive impairment and is unable to provide consent.
Quality of life of people with dementia living in RACFs will be measured using the 13-item QOL-AD scale. The QOL-AD scale will be used to rate patients’ mood, physical health, activities, relationships, and ability to complete tasks by using 1-4 (poor, fair, good, or excellent) and their associations with psychotropic medications.
Dementia will be diagnosed using ICD 10 criteria and the presence and severity of Behavioural and Psychological Symptoms of Dementia (BPSD) by using the well-established Neuropsychiatric Inventory (NPI), which detects, quantifies and tracks changes of psychiatric symptoms in a demented population. A Bristol activity of daily living scale will be utilised to assess an individual’s ability to carry out daily activities. This scale will assess individual ability based on a 20- item questionnaire on factors such as dressing, preparing food, using transport and so forth.

the duration of observational study: baseline , 6 months and 12 months after the educational intervention
Intervention code [1] 317068 0
Not applicable
Comparator / control treatment
part of randomised control trial project
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323171 0
Quality of life (QoL):
Quality of life of people with dementia living in RACFs will be measured using the 13-item QOL-AD scale. The QOL-AD scale will be used to rate patients’ mood, physical health, activities, relationships, and ability to complete tasks by using 1-4 (poor, fair, good, or excellent) and their associations with psychotropic medications.
Timepoint [1] 323171 0
baseline,after the intervention (6months), 12 months
Secondary outcome [1] 381029 0
Cognitive impairment :

Standardised Mini-Mental State Examination (SMMSE) will be used as a
screening test for the purpose of evaluating cognitive impairment in older adults.
Timepoint [1] 381029 0
baseline,after the intervention (6 months), 12 months
Secondary outcome [2] 381242 0
Behavioural and Psychological Symptoms of Dementia (BPSD):

The presence and severity of Behavioural and Psychological Symptoms of Dementia (BPSD) will be measured by using the well-established Neuropsychiatric Inventory (NPI), which detects, quantifies and tracks changes of psychiatric symptoms in a demented population.
Timepoint [2] 381242 0
baseline,after the intervention (6 months), 12 months
Secondary outcome [3] 381243 0
Activity daily living:

A Bristol activity of daily living scale will be utilised to assess an individual’s ability to carry out daily activities. This scale will assess individual ability based on a 20- item questionnaire on factors such as dressing, preparing food, using transport and so forth.
Timepoint [3] 381243 0
baseline,after the intervention (6 months), 12 months

Eligibility
Key inclusion criteria
Diagnosis of dementia/cognitive impairment in RACFs will be used to select participants for this substudy. Study participants will be identified based on a recorded medical dementia diagnosis, or a diagnosis that will be evaluated during the study.

The participants will be selected from the recruited nursing homes (intervention groups) of ACTRN12620000268943 trial.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents with severe dementia,unable to give verbal answers.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
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)
WA

Funding & Sponsors
Funding source category [1] 305196 0
Government body
Name [1] 305196 0
Department of Health/ Dementia Training Australia (WA)
Address [1] 305196 0
Level 6 MRF Building, Royal Perth Hospital
Rear 50 Murray St, Perth, Western Australia. Postcode: 6009
Post: M577 University of Western Australia, Stirling Hwy, Crawley. Perth, Western Australia.
Postcode: 6009
Country [1] 305196 0
Australia
Funding source category [2] 305197 0
Government body
Name [2] 305197 0
Dementia Training Australia (WA)
Address [2] 305197 0
Level 6 MRF Building, Royal Perth Hospital
Rear 50 Murray St, Perth, Western Australia. Postcode: 6009
Post: M577 University of Western Australia, Stirling Hwy, Crawley.
Perth, Western Australia. Postcode: 6009
Country [2] 305197 0
Australia
Primary sponsor type
Government body
Name
Dementia Training Australia (WA)
Address
Level 6 MRF Building, Royal Perth Hospital
Rear 50 Murray St, Perth, Western Australia. Postcode: 6009.
Post: M577 University of Western Australia, Stirling Hwy, Crawley.
Perth, Western Australia. Postcode: 6009
Country
Australia
Secondary sponsor category [1] 305557 0
None
Name [1] 305557 0
Address [1] 305557 0
Country [1] 305557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305551 0
Human Ethics University of Western Australia
Ethics committee address [1] 305551 0
The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia
T +61 8 6488 3703 / 4703
F +61 8 6488 8775
E humanethics@uwa.edu.au
Ethics committee country [1] 305551 0
Australia
Date submitted for ethics approval [1] 305551 0
Approval date [1] 305551 0
09/05/2019
Ethics approval number [1] 305551 0
RA/4/20/4792

Summary
Brief summary
The aims of this study are as follows:
1. To determine whether an education program directed at nurses, pharmacists and professional care staff will reduce the use of sedative medications in older people with dementia living in Residential Aged Care
Facilities (RACF).
2. To determine the effects of the education program and other factors on the number of
sedative medications that older people with dementia regularly consume.
The sub-project shares the same aims with the main project. The main project is aimed to
reduce the use of antipsychotics and benzodiazepines among residents with dementia through the
education program. These medications were associated with a significant increase in adverse events and an increased risk of mortality. Previous studies have suggested that these medications can also affect the cognitive state among older adults with dementia. Benzodiazepine use has been associated with accelerated cognitive decline and limited benefits. Antipsychotic medications have also been associated with considerable cognitive adverse effects in people with dementia. Degeneration of cognitive function and mood often reduces quality of life amongst people living with dementia. Therefore, it is important to investigate the effect of these medications on cognitive state and the quality of life of dementia residents .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100762 0
Prof Leon Flicker
Address 100762 0
Director, Western Australian Centre for Health & Ageing UWA

Royal Perth Hospital
MRF Building, Level 6
Rear 50 Murray Street, Perth, Western Australia. Postcode: 6009
M577 University of Western Australia, Stirling Hwy, Crawley. Perth, Western Australia.
Postcode: 6009
Country 100762 0
Australia
Phone 100762 0
+61 8 9224 0377
Fax 100762 0
Email 100762 0
phhend@hotmail.com
Contact person for public queries
Name 100763 0
Mrs Hend M. Almutairi
Address 100763 0
Level 6 MRF Building, Royal Perth Hospital Rear 50 Murray St, Perth, Western Australia. Postcode: 6009
Post: M577 University of Western Australia, Stirling Hwy, Crawley.Perth, Western Australia.
Postcode: 6009
Country 100763 0
Australia
Phone 100763 0
+61 412031620
Fax 100763 0
Email 100763 0
phhend@hotmail.com
Contact person for scientific queries
Name 100764 0
Prof Leon Flicker
Address 100764 0
Director, Western Australian Centre for Health & Ageing UWA
Royal Perth Hospital
MRF Building, Level 6
Rear 50 Murray Street, Perth, Western Australia. Postcode: 6009
Post: M577 University of Western Australia, Stirling Hwy, Crawley. Perth, Western Australia.
Postcode: 6009
Country 100764 0
Australia
Phone 100764 0
+61 8 9224 0377
Fax 100764 0
Email 100764 0
leon.flicker@uwa.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 other documents available
Summary results
No Results