Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12610000189022
Ethics application status
Approved
Date submitted
26/02/2010
Date registered
2/03/2010
Date last updated
2/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an instrument for the assessment and management of behavioural and psychological symptoms of dementia in aged care
Scientific title
Can aged care staff, and residents with behavioural and psychological symptoms of dementia (BPSD), benefit from staff training in the use of an assessment and management tool for challenging behaviours in residential care and/or education and clinical support regarding BPSDs, by demonstrating reduced stress, improved attitudes towards working with people with dementia, and greater job satisfaction among staff and reductions in the frequency and severity of BPSDs among residents.
Secondary ID [1] 1452 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
behavioural and psychological symptoms of dementia 256822 0
Condition category
Condition code
Mental Health 256971 256971 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be three treatment conditions. CONDITION ONE: Aged care staff participants in condition one will receive training in the use of an assessment and management instrument for challenging behaviours in residential care. This training will involve a single two-hour session and will be conducted as a group session by one of the investigators. Condition one participants will also participate in a single session, two-hour educational workshop designed to teach aged care staff how to identify and manage the causes of challenging behaviours in aged care residents with dementia. Staff who participate in the educational workshop will also receive three months of fortnightly clinical support visits, carried out by an experienced clinician.
CONDITION TWO: Aged care staff participants in condition two will receive the educational workshop and three months clinical support, but they will not receive the training session in the use of the assessment and management instrument.
CONDITION THREE: Aged care staff participants in condition three will receive the training session in the use of the assessment and management instrument, but they will not participate in the educational workshop or receive the three months of clinical support.
Intervention code [1] 256028 0
Behaviour
Comparator / control treatment
Active control;
Staff in the control condition will not receive the training session, the educational workshop or the clinical support. These participants will continue with their standard care routines and will be offered the training and educational workshop at the conclusion of the study
Control group
Active

Outcomes
Primary outcome [1] 257859 0
Reduced frequency and/or severity of behavioural and psychological symptoms of dementia in aged care residents. A research assistant who is blind to the treatment conditions will observe and record the frequency and/or severity of BPSDs in the participating residents on a behaviour monitoring sheet. Frequently occurring behaviours will be observed and recorded over a three hour period and infrequent behaviours will be observed and recorded over a five day period.
Timepoint [1] 257859 0
At baseline and three months and six months after intervention
Primary outcome [2] 257860 0
Reduced stress among staff associated with behavioural and psychological symptoms in residents, as assessed by a questionnaire containing the Carer Stress Scale.
Timepoint [2] 257860 0
At baseline and three months and six months after intervention
Primary outcome [3] 257861 0
Improvements in job satisfaction and attitudes towards working with people with dementia among aged care staff, as assessed through a questionnaire containing questions on satisfaction with work in aged care and the Approaches to Dementia scale
Timepoint [3] 257861 0
At baseline, and three and six months after intervention
Primary outcome [4] 257928 0
Improvements in staff perceptions of self-efficacy in dealing with challenging behaviours, as assessed by a questionnaire containing the Self-efficacy in Working with Dementia scale
Timepoint [4] 257928 0
At baseline and three and six months after intervention
Secondary outcome [1] 263313 0
Reduced frequency of general practitioner (GP) or other medical practitioner visits to treat BPSDs. This will be determined by viewing the resident's medical files and recording the number of visits in the previous three months
Timepoint [1] 263313 0
At baseline and three months and six months after the intervention
Secondary outcome [2] 263314 0
Changes in psychotropic medications including reduced reliance on antipsychotics to treat behavioural symptoms. This information will be obtained from the medication records in the residents' file. The investigator will record the residents' current psychotropic medications as well as any changes in these medications in the previous three months
Timepoint [2] 263314 0
At baseline and three months and six months after the intervention

Eligibility
Key inclusion criteria
Residents: Aged care residents with dementia who present with behavioural and psychological symptoms that are identified by facility managers as challenging
Staff: Aged care staff who work with the resident population in this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents: Aged care residents that do not have a dementia diagnosis or do not present with challenging behaviours and psychological symptoms, residents with a diagnosis of schizophrenia
Staff: Aged care staff that do not work with the resident population used in this 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)
Aged care facilities, and not the individual staff and residents, will be randomly allocated to each condition. Aged care agencies, that are collaborative partners in the study, will nominate facilities to participate in the study, and these facilities will then be randomly allocated to one of the four treatment conditions. The person who nominates the aged care facilities will be unaware, when the decision is made, to which condition each facility would be allocated. Allocation will be decided by central randomisation using computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256528 0
Government body
Name [1] 256528 0
National Health and Medical Research Council
Country [1] 256528 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 255836 0
Other Collaborative groups
Name [1] 255836 0
Greater Southern Area Health Service
Address [1] 255836 0
34 Lowe St
Queanbeyan NSW 2620
Country [1] 255836 0
Australia
Other collaborator category [1] 1122 0
Other Collaborative groups
Name [1] 1122 0
Benetas
Address [1] 1122 0
Level 1, 789 Toorak Road,
Hawthorn East, VIC 3123
Country [1] 1122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258575 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 258575 0
Ethics committee country [1] 258575 0
Australia
Date submitted for ethics approval [1] 258575 0
Approval date [1] 258575 0
01/06/2009
Ethics approval number [1] 258575 0
HEAG-H 92/09

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

Contacts
Principal investigator
Name 30849 0
Address 30849 0
Country 30849 0
Phone 30849 0
Fax 30849 0
Email 30849 0
Contact person for public queries
Name 14096 0
Marita McCabe
Address 14096 0
221 Burwood Hwy,
Burwood, VIC, 3125
Country 14096 0
Australia
Phone 14096 0
+61 3 9244 6856
Fax 14096 0
Email 14096 0
marita.mccabe@deakin.edu.au
Contact person for scientific queries
Name 5024 0
Tanya Davison
Address 5024 0
221 Burwood Hwy,
Burwood, VIC, 3125
Country 5024 0
Australia
Phone 5024 0
+61 3 9244 6505
Fax 5024 0
Email 5024 0
tanya.davison@deakin.edu.au

No information has been provided regarding IPD availability


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.