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Trial registered on ANZCTR


Registration number
ACTRN12614000568617
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
28/05/2014
Date last updated
22/04/2020
Date data sharing statement initially provided
22/04/2020
Date results information initially provided
22/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot evaluation of the effectiveness and feasibility of a personalised multimedia interface device for aged care residents with dementia
Scientific title
For aged care residents with dementia is a personalised multimedia interface device feasible and effective in improving quality of life and agitation?
Secondary ID [1] 284591 0
Nil
Universal Trial Number (UTN)
U1111-1156-7811
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 291884 0
Behavioural and psychological symptoms of dementia 291885 0
Poor quality of life 291886 0
Condition category
Condition code
Neurological 292228 292228 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of access to 'Memory Box' - an individualised multimedia interface device, which contains photographs, movies, family video messages, and music that is personally relevant to each individual. The participants will have access to Memory Box for 24 hours per day for a period of 4 weeks. They will receive weekly 30 minute training sessions to assist them in using the device, plus the research team will visit weekly to ensure the device is operating correctly and address any issues in using the device. Facility staff and visiting family members will also assist participants in using the device, with details about this assistance provided to the research team at the end of the intervention. Adherence to the intervention will be monitored using an automated log of usage of the device, which is built into the program. At the end of the intervention, the amount of time each participant has used each type of media will be extracted from the device.

As this is an nonpharmacological intervention, no 'wash-out' period is required between the intervention and control conditions.
Intervention code [1] 289363 0
Treatment: Devices
Comparator / control treatment
Social control, with 30 minute weekly visits to discuss current affairs, facilitated with the daily newspaper, over a 4 week period. This controls for the increased social interaction provided in the training sessions as part of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 292100 0
Increase in quality of life, measured using the Quality of life in Alzheimer’s Disease (QOL-AD; Logsdon et al., 1999), a brief, 13-item measure that is administered to the resident using an interview format and to a staff member using a questionnaire. Where the resident is unable to complete the self-report (e.g., some participants with moderate dementia), only the informant section will be used. The items cover multiple domains (relationships with friends and family, physical condition, mood, etc) of concern to people with dementia. We will use the adaptations for individuals in residential aged care settings described in Edelman et al. (2005).
Timepoint [1] 292100 0
Baseline, 4 weeks after baseline
Primary outcome [2] 292101 0
Reduction in agitation associated with dementia, measured using the Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al., 1989). This is a widely-used informant-rated measure of the frequency with which a person with dementia manifests 29 agitated behaviours over a one week period (modification from the original two week period). A minimum of two staff members will collaborate in completing the scale, based on findings of improved reliability using this technique (Moniz-Cook et al., 2001).
Timepoint [2] 292101 0
Baseline, 4 weeks after baseline
Secondary outcome [1] 308204 0
Reduction in symptoms of depression, measured using the Cornell Scale for Depression in Dementia (Alexopoulos et al. 1988), administered in interview to both the resident and a staff members, with final scores reflecting the clinical judgement of the assessor
Timepoint [1] 308204 0
Baseline and 4 weeks after baseline
Secondary outcome [2] 308205 0
Reduction in symptoms of anxiety, measured using the Rating for Anxiety In Dementia instrument (Shankar et al., 1999), which involves an interview with a member of care staff and a patient interview. The structured interview guide for this rating scale reported by Snow et al. (2012) will be employed.
Timepoint [2] 308205 0
Baseline and 4 weeks after baseline
Secondary outcome [3] 308206 0
Reduction in level of carer burden reported by aged care staff, measured using a version of the Burden Interview, modified for use with professional carers (Sourial et al., 2001). Two staff members will each complete the instrument and a mean score calculated.
Timepoint [3] 308206 0
Baseline and 4 weeks after baseline
Secondary outcome [4] 308207 0
Satisfaction with Memory Box, through a semi-structured interview and brief scale designed specifically for this study. Satisfaction data will be collected from each participant, a staff member and a family member at the end of the intervention.
Timepoint [4] 308207 0
At the end of the 4 week intervention
Secondary outcome [5] 308208 0
Feasibility data - including amount of support required to operate Memory Box, difficulties experienced in using Memory Box. This will be assessed using a semi-structured interview with each participant, a staff member and a family member.
Timepoint [5] 308208 0
At the end of the 4 week intervention

Eligibility
Key inclusion criteria
Permanent resident in an aged care facility
Diagnosis of dementia
Availability of a family member to assist in sourcing personalised media
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute medical illness that would be compromised by participation in the study.

Severe dementia (MMSE < 10)

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A Multiple Analysis of Covariance (MANCOVA) will be used to compare outcome measures at baseline and post-intervention. This method allows for comparison of multiple outcomes simultaneously, and also controls for any differences between groups in baseline scores.

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 289224 0
Other Collaborative groups
Name [1] 289224 0
Dementia Collaborative Research Centre: Assessment and Better Care
Address [1] 289224 0
School of Psychiatry
Faculty of Medicine
Level 3, AGSM Building
University of New South Wales
Sydney
NSW 2052
Country [1] 289224 0
Australia
Primary sponsor type
Individual
Name
Dr Tanya Davison
Address
Aged Mental Health Research Unit, Monash University
Kingston Centre, Warrigal Road, Cheltenham, VIC 3192.
Country
Australia
Secondary sponsor category [1] 287895 0
Individual
Name [1] 287895 0
Prof Daniel O'Connor
Address [1] 287895 0
Aged Mental Health Research Unit, Monash University
Kingston Centre, Warrigal Road, Cheltenham, VIC 3192.
Country [1] 287895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290991 0
Monash University HREC
Ethics committee address [1] 290991 0
Human Ethics
Monash Research Office
Monash University
Level 1, Building 3e, Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [1] 290991 0
Australia
Date submitted for ethics approval [1] 290991 0
21/08/2013
Approval date [1] 290991 0
11/09/2013
Ethics approval number [1] 290991 0
2010001679 - CF10/3129

Summary
Brief summary
(i) Aims of the project
Aged care residents with dementia present with high rates of agitated behaviour and lowered quality of life, which is associated with symptoms of depression and anxiety, and carer burden. While research has demonstrated that personalised activities and stimuli (such as favourite music and audio recordings of family members) can help in addressing these behaviours, people with marked dementia are often unable to access them without the direct assistance of family or staff carers. Our team has designed a device that provides easy access to personalised multimedia, including photographs, music, videotaped family greetings and movies on a portable device. In this project, we aim to evaluate the effectiveness of this device in reducing agitated behaviour and improving quality of life among aged care residents with dementia and also examine its feasibility for routine use.

Hypotheses:
(1) Participants who receive the personalised multimedia interface device will have decreased severity and frequency of agitated behaviour and improved quality of life relative to their scores during the control period.
(2) Participants who receive the device will also report lower levels of depression and anxiety.
(2) Aged care staff will perceive their carer role as less burdensome during the period when the resident receives the device than during the control period.

In addition, our feasibility study will (i) determine what level of support from staff and families is required for participants to use the device; (ii) establish patterns of use over a one month period; and (iii) determine levels of satisfaction with this novel approach.
Trial website
Trial related presentations / publications
Davison, T. E., Nayer, K. S., Coxon, S. C., de Bono, A., Eppingstall, B., Jeon, Y. H., van der Ploeg, E. S., & O’Connor, D. W. (2015). A personalised multimedia device to treat agitated behaviour and improve mood in people with dementia: A pilot study. Geriatric Nursing, 37(1), 25-29. DOI: 10.1016/j.gerinurse.2015.08.013.
Public notes

Contacts
Principal investigator
Name 48318 0
Dr Tanya Davison
Address 48318 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 48318 0
Australia
Phone 48318 0
+61 3 9265 1700
Fax 48318 0
Email 48318 0
tanya.davison@monash.edu
Contact person for public queries
Name 48319 0
Dr Tanya Davison
Address 48319 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 48319 0
Australia
Phone 48319 0
+61 3 9265 1700
Fax 48319 0
Email 48319 0
tanya.davison@monash.edu
Contact person for scientific queries
Name 48320 0
Dr Tanya Davison
Address 48320 0
Aged Mental Health Research Unit
Monash University
Kingston Centre
Warrigal Road
Cheltenham
VIC 3192
Country 48320 0
Australia
Phone 48320 0
+61 3 9265 1700
Fax 48320 0
Email 48320 0
tanya.davison@monash.edu

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?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 7711 0
Davison, T. E., Nayer, K. S., Coxon, S. C., de Bono, A., Eppingstall, B., Jeon, Y. H., van der Ploeg, E. S., & O’Connor, D. W. (2015). A personalised multimedia device to treat agitated behaviour and improve mood in people with dementia: A pilot study. Geriatric Nursing, 37(1), 25-29. DOI: 10.1016/j.gerinurse.2015.08.013
Attachments [1] 7711 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary