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Trial registered on ANZCTR


Registration number
ACTRN12614000508673
Ethics application status
Approved
Date submitted
6/05/2014
Date registered
13/05/2014
Date last updated
13/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia.
Scientific title
Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia: A cluster randomised controlled trial
Secondary ID [1] 284549 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 291814 0
Condition category
Condition code
Mental Health 292175 292175 0 0
Other mental health disorders
Neurological 292176 292176 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare Usual Care (UC) with an innovative interactive therapeutic robot (PARO) and with a look-alike Plush Toy (PT - without the artificial intelligent aspects of the robot) in terms of reducing emotional and behavioural (agitation) symptoms of dementia. PARO is a therapeutic pet-type robot, with the appearance of a baby harp seal and it is the size of a newborn baby. It has tactile sensors and moves its tail and flippers, and opens its eyes when petted. Artificial intelligence software changes the robot’s behaviours based on an array of sensors that monitor sound, light, temperature and touch. It responds to sounds, can learn its name and learns to respond to words its owner uses frequently. It can show emotions such as surprise, happiness and anger and will cry if it is not receiving sufficient attention. It produces sounds similar to a real baby seal and is active during the day and asleep at night. Participants allocated to the PARO condition will be introduced to and left to play with the robot delivered by the trained research assistants (RAs) at the start of each session and collected at the end of each session. Participants will receive three individual non-facilitated PARO sessions per week, for 15 minutes for 10 weeks.
RAs will be kept constant for each individual throughout the intervention. Video observation will be done during intervention via a small unobtrusive video camera held by the RA, who will sit in a position where video footage can be captured without the RA being intrusive.
Intervention code [1] 289313 0
Behaviour
Intervention code [2] 289314 0
Treatment: Devices
Intervention code [3] 289315 0
Treatment: Other
Comparator / control treatment
Participants will receive three individual non-facilitated PT sessions per week, for 15 minutes for 10 weeks. The PT looks like PARO but has no robotic features. Participants allocated to the usual care condition will receive UC. A 10-week intervention will allow both short (5 week-same as pilot) and long-term follow-up (10 weeks). We will also conduct a follow-up 15-week period to examine long-term sustainability following withdrawal of the intervention, and this will assist with the cost comparison of the interventions.
Control group
Placebo

Outcomes
Primary outcome [1] 292058 0
Changes in types and frequency of agitation and mood measured by Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF; 14 short item).
Timepoint [1] 292058 0
CMAI-SF - prior to randomisation and during intervention - 5 sessions, 15-mins before intervention and during the 15-mins intervention. The 5 observed sessions are scheduled at week 0 (baseline), 1, 5, 10, 15 (5 sessions observed in total; total of 2.5 hours per participant).
Primary outcome [2] 292088 0
Engagement measured by video observations (Noldus Observer XT).
Timepoint [2] 292088 0
Noldus Observation - 5 sessions, 15-mins before intervention and during the 15-mins intervention. Also collected at 15-weeks post-intervention. The 5 observed sessions are scheduled at week 0 (baseline), 1, 5, 10, 15 (5 sessions observed in total; total of 2.5 hours per participant).
Secondary outcome [1] 308101 0
Sleep patterns measured by SenseWear arm monitors placed on each participant's arm.
Timepoint [1] 308101 0
The SenseWear armband will be placed on each participant for a 24-hour period at week 0 (baseline), and 2 x 24 hour periods at weeks 5 and 10 on a day when the PARO or PT intervention is being delivered and during usual care. Also collected at 15-weeks post-intervention.
Secondary outcome [2] 308102 0
PRN pyschotropic medication use will be audited for four periods.
Timepoint [2] 308102 0
5-weeks prior to intervention, week 5, 10 and follow-up assessment at 15-weeks post-intervention.
Secondary outcome [3] 308103 0
Residential aged care facility staff and family satisfaction with the use of PARO, PT and UC.
Timepoint [3] 308103 0
Interviews will be conducted within a fortnight of the completion of the individual interventions.

Eligibility
Key inclusion criteria
A documented diagnosis of dementia and a RUDAS28 score of 22 or less (to accommodate culturally and linguistically diverse (CALD) residents)
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A dual diagnosis of a serious or persistent mental illness, e.g. schizophrenia; a terminal illness; in respite care; and unremitting pain or distressing physical symptoms.

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)
27 RACFs which agree to participate will be randomized within 2 strata, into one of the three groups, 1) PARO, 2) PT, 3) UC.
For each stratum, random permutations will be produced with the starting number taken independently for each stratum. Randomly variable block sizes will be used. Other potential cofounders such as building, design and/or staffing will be adjusted accordingly in the analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web-based, centralized independent randomization service based at Griffith University and overseen by a biostatiscian.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Cluster and Individual level analyses will be carried out to test all hypotheses. Complex analytic approaches that include the Generalised Linear Models (GLM), Generalized Estimation Equations (GEE) and Multi-Level Modeling (MLM), which allow adjustment for potential covariates at both cluster and individual levels, will be used. In line with outcomes observed in the pilot study and similar
outcomes in other research using an individualised intervention for agitation reduction sample size of 345 participants, 115 in each arm, will be required to detect a 25% reduction in agitation level (at a power of 0.90, a = .05). The sample size was computed using two steps. Sample size required for a simple randomised complete trial design (RCT) was 75 in each arm. This was then multiplied by the design effect to account for the nested structure in a C-RCT. Adjusted to account for clustering based on an Intra Class Correlation (ICC) of 0.0730 we determined that at least 115 patients would be required in each arm if we were to use 10 clusters per arm (n=345). Allowing for a potential drop out of 10% will increase the total targeted sample to a recruitment sample of 380 participants. To ensure this sample size we will involve 27 sites in the study with a target of 13 participants at each site.

Recruitment
Recruitment status
Recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 289178 0
Government body
Name [1] 289178 0
National Health and Medical Research Council
NHMRC Project Grant APP1065320
Address [1] 289178 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 289178 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan, Brisbane
QLD 4111
Country
Australia
Secondary sponsor category [1] 287847 0
None
Name [1] 287847 0
Address [1] 287847 0
Country [1] 287847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290958 0
Griffith University Ethics Committee
Ethics committee address [1] 290958 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Ethics committee country [1] 290958 0
Australia
Date submitted for ethics approval [1] 290958 0
Approval date [1] 290958 0
28/02/2014
Ethics approval number [1] 290958 0
NRS/03/14/HREC

Summary
Brief summary
To compare Usual Care (UC) with an innovative interactive therapeutic robot (PARO) and with a look-alike Plush Toy (PT - without the artificial intelligent aspects of the robot) in terms of reducing emotional and behavioural (agitation) symptoms of dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48130 0
Prof Wendy Moyle
Address 48130 0
Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111
Country 48130 0
Australia
Phone 48130 0
+61-7-37355526
Fax 48130 0
Email 48130 0
w.moyle@griffith.edu.au
Contact person for public queries
Name 48131 0
Prof Wendy Moyle
Address 48131 0
Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111
Country 48131 0
Australia
Phone 48131 0
+61-7-37355526
Fax 48131 0
Email 48131 0
w.moyle@griffith.edu.au
Contact person for scientific queries
Name 48132 0
Prof Wendy Moyle
Address 48132 0
Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111
Country 48132 0
Australia
Phone 48132 0
+61-7-37355526
Fax 48132 0
Email 48132 0
w.moyle@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results