Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000627853
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
12/06/2012
Date last updated
15/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of PARO (Therapeutic Robots) on quality of life (in people living with dementia in residential care
Scientific title
The effect of PARO (Therapeutic Robots) on social engagement, communication, and quality of life (QOL) in people living with dementia in residential care
Secondary ID [1] 259765 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 261341 0
Condition category
Condition code
Mental Health 259495 259495 0 0
Other mental health disorders
Neurological 286971 286971 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare the effects of PARO (a therapeutic, pet-type robot with the appearance of a baby harp seal) and participation in a reading group on social engagement, communication and QOL in people living with moderate to severe dementia in a residential care setting. Participants will be engaged in a structured group activity involving either PARO or a reading activity for 45 minutes, three times a week, for 5 weeks. This will be followed by 3 weeks of no activity (wash-out period), after which participants will ‘cross-over’ treatment groups and experience 5 weeks of the opposite activity (also three times a week for 45 minutes each time).
Intervention code [1] 264191 0
Behaviour
Intervention code [2] 285056 0
Treatment: Devices
Intervention code [3] 285057 0
Treatment: Other
Comparator / control treatment
Reading will include three, 40-minute group reading sessions per week for 5 weeks. A reading group represents ‘usual care’ for diversional therapy. A facilitator reads to and interacts with questions addressed to the group. After completion of the first treatment arm of the study, post-test measures will be collected and participants will receive no research-structured activity for three weeks (wash-out). Following the wash-out period, participants will then ‘cross-over’ and complete the second treatment arm, followed by a second round of post-testing.
Control group
Active

Outcomes
Primary outcome [1] 262299 0
Social engagement (including communication) and emotional state using Observation Measure of Engagement (OME) and the Observed Emotion Rating Scale (OERS).
Timepoint [1] 262299 0
During each session
Primary outcome [2] 262301 0
Anxiety using Rating Anxiety in Dementia Scale (RAID) and Geriatric Depression Scale (GDS).
Timepoint [2] 262301 0
Baseline and post-test
Secondary outcome [1] 273496 0
Quality of Life using Quality of Life in Alzheimers' Disease Scale (QoL-AD)
Timepoint [1] 273496 0
Baseline and post-test
Secondary outcome [2] 273497 0
Apathy using Apathy Evaluation Scale (AES)
Timepoint [2] 273497 0
Baseline and post-test

Eligibility
Key inclusion criteria
Aged 65 years or older; have a diagnosis of mid to late stage dementia, or meet the criteria for probable mid to late stage dementia of the Alzheimer’s type as per the DSM-IV; be identified by family or staff as socially isolated, depressed, or having low quality of life; be able to sit upright comfortably in chair / wheelchair so that they can see the PARO activity; be able to move both hands.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Blind or severely deaf

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation - under the guidance of a biostatistician, a research assistant not associated with data collection will conduct the randomization process using a computer-generated program to determine the different ordering of treatments for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2011
Actual
16/02/2011
Date of last participant enrolment
Anticipated
Actual
9/03/2011
Date of last data collection
Anticipated
Actual
29/06/2011
Sample size
Target
16
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 264637 0
Government body
Name [1] 264637 0
Dementia Collaborative Research Centres (DCRC) - Carers and Consumers (CC) - Department of Health and Ageing (DOHA)
Country [1] 264637 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country
Australia
Secondary sponsor category [1] 284272 0
None
Name [1] 284272 0
Address [1] 284272 0
Country [1] 284272 0
Other collaborator category [1] 251866 0
Individual
Name [1] 251866 0
Glenda Cook
Address [1] 251866 0
Northumbria University
Ellison Place
Newcastle upon Tyne
NE1 8ST, UK
Country [1] 251866 0
United Kingdom
Other collaborator category [2] 251867 0
Individual
Name [2] 251867 0
Barbara Klein
Address [2] 251867 0
Fachochschule Frankfurt am Main,
Nibelungenplatz 1
60318 Frankfurt am Main
Gebaude 2, Raum 109a
Germany
Country [2] 251867 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266638 0
Griffith University Ethics Committee
Ethics committee address [1] 266638 0
Ethics committee country [1] 266638 0
Australia
Date submitted for ethics approval [1] 266638 0
Approval date [1] 266638 0
09/02/2011
Ethics approval number [1] 266638 0
NRS/32/10

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

Contacts
Principal investigator
Name 32330 0
Prof Wendy Moyle
Address 32330 0
Griffith University, Nathan campus, 170 Kessels Road Nathan, Brisbane, QLD, Australia 4111.
Country 32330 0
Australia
Phone 32330 0
+61 (0) 7 3735 5526
Fax 32330 0
Email 32330 0
[email protected]
Contact person for public queries
Name 15577 0
Professor Wendy Moyle
Address 15577 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Country 15577 0
Australia
Phone 15577 0
+61 (0) 7 3735 5526
Fax 15577 0
Email 15577 0
[email protected]
Contact person for scientific queries
Name 6505 0
Professor Wendy Moyle
Address 6505 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Country 6505 0
Australia
Phone 6505 0
+61 (0) 7 3735 5526
Fax 6505 0
Email 6505 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.