Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000353695
Ethics application status
Approved
Date submitted
27/03/2014
Date registered
2/04/2014
Date last updated
15/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting aged care nursing staff to electronically manage resident’s behavioural and psychological symptoms of dementia in real time.
Scientific title
A program to support aged care nursing staff to electronically manage resident’s behavioural and psychological symptoms of dementia in real time using a web-based application.
Secondary ID [1] 284343 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural and psychological symptoms of dementia 291497 0
Condition category
Condition code
Neurological 291866 291866 0 0
Dementias
Mental Health 291867 291867 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will provide nursing staff and personal care assistants in aged care residential facilities with a mobile and web-based system (Nurses Behavioural Assistant; NBA) to help address the behavioural and psychological symptoms of dementia in real time. This will be provided for a period of 4 weeks.
Nursing staff and personal care assistants will be provided with a 1 hour training session on how to use the NBA prior to the commencement of the research. The NBA is an online system that presents nurses with a number of common behavioural and psychological symptoms of dementia which can be selected. Once selected, a series of behavioural intervention strategies will be presented. Recommendations will be provided until nursing staff find a resolution to the problem. Interventions include areas such as wandering, aggression and sleep disturbances. Nursing staff will be asked to provide information on the presenting problem, intervention used, and its effectiveness via the NBA. This information will be recorded in the NBA and be assessable to nursing staff and researchers throughout the research period.
Nursing staff and personal care assistants will also have access to an online web dashboard. This will graph and track the resident’s behaviour and interventions as imputed by the nursing staff. The web dashboard will also provide additional resources such as assessment tools and fact sheets.
Intervention code [1] 289067 0
Behaviour
Comparator / control treatment
Baseline assessments of nursing staff knowledge of dementia will be conducted.

Baseline assessments of residents anxiety, depression, confusion, agitation and the number of behavioural and psychological symptoms of dementia experienced will be conducted. Data on age, gender, date of admission, any current diagnosis (medical and psychiatric), any assessments done in the last 12 months, behaviour incident reports and current medications (including vitamins) will be collected from participants facility files.

Control group
Uncontrolled

Outcomes
Primary outcome [1] 291785 0
Engagement with the NBA system will be measured by observation and semi-structured in-depth interviews post test
Timepoint [1] 291785 0
Baseline and post-test after 4 weeks.
Secondary outcome [1] 307519 0
Nursing staff dementia knowledge will be measured by the Dementia Knowledge Assessment Tool Version 2 (DKAT)
Timepoint [1] 307519 0
Baseline and post-test after 4 weeks.
Secondary outcome [2] 307520 0
Anxiety and depression in residents will be measured by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 307520 0
Baseline and post-test after 4 weeks.
Secondary outcome [3] 307521 0
Number of behavioural and psychological symptoms of dementia residents experience as measured by the number of events entered by nursing staff into the NBA system.
Timepoint [3] 307521 0
Baseline and post-test after 4 weeks.
Secondary outcome [4] 307522 0
Confusion in residents will be measured by The Confusion Assessment Method (CAM).
Timepoint [4] 307522 0
Baseline and post-test after 4 weeks.
Secondary outcome [5] 307523 0
Agitation in residents will be measured by the Brief Agitation Rating Scale (BARS).
Timepoint [5] 307523 0
Baseline and post-test after 4 weeks.

Eligibility
Key inclusion criteria
Australian resident; currently residing in an aged care residential facility.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Written consent not provided.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2014
Actual
29/07/2014
Date of last participant enrolment
Anticipated
Actual
28/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288979 0
Charities/Societies/Foundations
Name [1] 288979 0
The Telematics Trust
Country [1] 288979 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive
Mt Helen VIC 3350
Country
Australia
Secondary sponsor category [1] 287658 0
None
Name [1] 287658 0
None
Address [1] 287658 0
None
Country [1] 287658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290790 0
Federation Univeristy Human Research Ethics Commitee
Ethics committee address [1] 290790 0
Ethics committee country [1] 290790 0
Australia
Date submitted for ethics approval [1] 290790 0
Approval date [1] 290790 0
14/02/2014
Ethics approval number [1] 290790 0
A14-008

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

Contacts
Principal investigator
Name 47274 0
Prof Britt Klein
Address 47274 0
Federation University, School of Health Sciences; DVC-Research and Innovation Portfolio; and the Collaborative Research Network

PO Box 663
Ballarat VIC 3353
Country 47274 0
Australia
Phone 47274 0
+61 3 5327 6717
Fax 47274 0
Email 47274 0
[email protected]
Contact person for public queries
Name 47275 0
Britt Klein
Address 47275 0
Federation University, School of Health Sciences; DVC-Research and Innovation Portfolio; and the Collaborative Research Network

PO Box 663
Ballarat VIC 3353
Country 47275 0
Australia
Phone 47275 0
+61 3 5327 6717
Fax 47275 0
Email 47275 0
[email protected]
Contact person for scientific queries
Name 47276 0
Britt Klein
Address 47276 0
Federation University,School of Health Sciences; DVC-Research and Innovation Portfolio; and the Collaborative Research Network

PO Box 663
Ballarat VIC 3353
Country 47276 0
Australia
Phone 47276 0
+61 3 5327 6717
Fax 47276 0
Email 47276 0
[email protected]

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.