ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000393954

Ethics application status

Approved

Date submitted

10/03/2020

Date registered

23/03/2020

Date last updated

17/12/2021

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]

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

Dementia

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Neurological

Dementias

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Months

Description of intervention(s) / exposure

This sub study objectives :To investigate the effect of a psychotropic education program on the quality of life (QoL) of residents of Western Australian residential aged care facilities (RACFs), and to examine the association between psychotropic medications and QoL.

Design: before-after study. Medication management consultancy (MMC) intervention involves educating staff to initiate nonpharmacological interventions and person-centred care as first line treatment for the management of neuropsychiatric symptoms expressed by residents.
Setting and participants: 56 residents recruited from four Australian residential aged care facilities.
Measures: QoL was assessed by the self-reported Quality of Life in Alzheimer’s Disease (QoL-AD), neuropsychiatric symptoms and staff distress by Neuropsychiatric Inventory–Questionnaire version (NPI-Q), cognition by Standardised Mini-Mental State Examination (SMMSE) and activity of daily living assessment by Bristol Activity of Daily Living Scale (BADLS). Medication data were obtained from residents’ medication charts. Repeated assessments of all the above variables were performed at 6 and 12 months.
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.

Intervention code [1]

Not applicable

Comparator / control treatment

part of randomised control trial project

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

baseline,after the intervention (6months), 12 months

Secondary outcome [1]

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]

baseline,after the intervention (6 months), 12 months

Secondary outcome [2]

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]

baseline,after the intervention (6 months), 12 months

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Residents with severe dementia,unable to give verbal answers.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties
Other reasons/comments

Other reasons

The COVID-19 pandemic and subsequent lockdown affected implementation of non-COVID-19-related educational interventions in RACFs . we were unable to recruit more than 56 residents from 5 RACFs (intervention group). COVID-19 prevented anymore recruited.

Date of first participant enrolment

Anticipated

Actual

25/11/2019

Date of last participant enrolment

Anticipated

Actual

10/03/2021

Date of last data collection

Anticipated

Actual

10/03/2021

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health/ Dementia Training Australia (WA)

Address [1]

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]

Australia

Funding source category [2]

Government body

Name [2]

Dementia Training Australia (WA)

Address [2]

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Ethics University of Western Australia

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/05/2019

Ethics approval number [1]

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

Prof Leon Flicker

Address

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

Australia

Phone

+61 8 9224 0377

Fax

phhend@hotmail.com

Contact person for public queries

Name

Hend M. Almutairi

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

Phone

+61 412031620

Fax

phhend@hotmail.com

Contact person for scientific queries

Name

Leon Flicker

Address

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

Australia

Phone

+61 8 9224 0377

Fax

leon.flicker@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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