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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

11/02/2021

Date data sharing statement initially provided

11/02/2021

Date results provided

11/02/2021

Type of registration

Prospectively 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Mental Health

Other mental health disorders

Neurological

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]

Behaviour

Intervention code [2]

Treatment: Devices

Intervention code [3]

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]

Changes in types and frequency of agitation and mood measured by Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF; 14 short item).

Timepoint [1]

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]

Engagement measured by video observations (Noldus Observer XT).

Timepoint [2]

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]

Sleep patterns measured by SenseWear arm monitors placed on each participant's arm.

Timepoint [1]

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]

PRN pyschotropic medication use will be audited for four periods.

Timepoint [2]

5-weeks prior to intervention, week 5, 10 and follow-up assessment at 15-weeks post-intervention.

Secondary outcome [3]

Residential aged care facility staff and family satisfaction with the use of PARO, PT and UC.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

5/05/2014

Actual

14/06/2014

Date of last participant enrolment

Anticipated

Actual

16/05/2015

Date of last data collection

Anticipated

Actual

29/08/2015

Sample size

Target

380

Accrual to date

Final

415

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council
NHMRC Project Grant APP1065320

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Road
Nathan, Brisbane
QLD 4111

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Ethics Committee

Ethics committee address [1]

170 Kessels Road
Nathan, Brisbane, QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/02/2014

Ethics approval number [1]

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

Moyle, W., Jones, C. J., Murfield, J. E., Thalib, L., Beattie, E., Shum, D., O'Dwyer, S. T., Mervin, M. C., & Draper, B. M. (2017). Use of a Robotic Seal as a Therapeutic Tool to Improve Dementia Symptoms: A Cluster-Randomized Controlled Trial. Journal of the American Medical Directors Association, 18(9), 766–773. https://doi.org/10.1016/j.jamda.2017.03.018

Mervin, M. C., Moyle, W., Jones, C., Murfield, J., Draper, B., Beattie, E., Shum, D., O'Dwyer, S., & Thalib, L. (2018). The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial. Journal of the American Medical Directors Association, 19(7), 619–622.e1. https://doi.org/10.1016/j.jamda.2017.10.008

Moyle, W., Bramble, M., Jones, C., & Murfield, J. (2018). Care staff perceptions of a social robot called Paro and a look-alike Plush Toy: a descriptive qualitative approach. Aging & mental health, 22(3), 330–335. https://doi.org/10.1080/13607863.2016.1262820

Moyle, W., Jones, C., Murfield, J., Thalib, L., Beattie, E., Shum, D., O'Dwyer, S., Mervin, M. C., & Draper, B. (2018). Effect of a robotic seal on the motor activity and sleep patterns of older people with dementia, as measured by wearable technology: A cluster-randomised controlled trial. Maturitas, 110, 10–17. https://doi.org/10.1016/j.maturitas.2018.01.007

Moyle, W., Jones, C., Murfield, J., Thalib, L., Beattie, E., Shum, D., & Draper, B. (2019). Using a therapeutic companion robot for dementia symptoms in long-term care: reflections from a cluster-RCT. Aging & mental health, 23(3), 329–336. https://doi.org/10.1080/13607863.2017.1421617

Moyle, W., Bramble, M., Jones, C. J., & Murfield, J. E. (2019). "She Had a Smile on Her Face as Wide as the Great Australian Bite": A Qualitative Examination of Family Perceptions of a Therapeutic Robot and a Plush Toy. The Gerontologist, 59(1), 177–185. https://doi.org/10.1093/geront/gnx180

Jones, C., Moyle, W., Murfield, J., Draper, B., Shum, D., Beattie, E., & Thalib, L. (2018). Does Cognitive Impairment and Agitation in Dementia Influence Intervention Effectiveness? Findings From a Cluster-Randomized-Controlled Trial With the Therapeutic Robot, PARO. Journal of the American Medical Directors Association, 19(7), 623–626. https://doi.org/10.1016/j.jamda.2018.02.014

Moyle, W., El Saifi, N., Draper, B., Jones, C., Beattie, E., Shum, D., Thalib, L., Mervin, C., & O Dwyer, S. (2017). Pharmacotherapy of Persons with Dementia in Long-Term Care in Australia: A Descriptive Audit of Central Nervous System Medications. Current drug safety, 12(2), 95–102. Advance online publication. https://doi.org/10.2174/1574886312666170209113203

Moyle, W., Beattie, E., Draper, B., Shum, D., Thalib, L., Jones, C., O'Dwyer, S., & Mervin, C. (2015). 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 protocol. BMJ open, 5(8), e009097. https://doi.org/10.1136/bmjopen-2015-009097

Public notes

Contacts

Principal investigator

Name

Prof Wendy Moyle

Address

Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111

Country

Australia

Phone

+61-7-37355526

Fax

[email protected]

Contact person for public queries

Name

Wendy Moyle

Address

Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111

Country

Australia

Phone

+61-7-37355526

Fax

[email protected]

Contact person for scientific queries

Name

Wendy Moyle

Address

Griffith University
170 Kessels Road,
Nathan, Brisbane
QLD, 4111

Country

Australia

Phone

+61-7-37355526

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10618	Study protocol	Moyle, W., Beattie, E., Draper, B., Shum, D., Thalib, L., Jones, C., O'Dwyer, S., & Mervin, C. (2015). 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 protocol. BMJ open, 5(8), e009097. https://doi.org/10.1136/bmjopen-2015-009097

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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 protocol.	2015	https://dx.doi.org/10.1136/bmjopen-2015-009097
Embase	Levels of physical activity and sleep patterns among older people with dementia living in long-term care facilities: A 24-h snapshot.	2017	https://dx.doi.org/10.1016/j.maturitas.2017.05.015
Embase	Use of a Robotic Seal as a Therapeutic Tool to Improve Dementia Symptoms: A Cluster-Randomized Controlled Trial.	2017	https://dx.doi.org/10.1016/j.jamda.2017.03.018
Embase	Effect of a robotic seal on the motor activity and sleep patterns of older people with dementia, as measured by wearable technology: A cluster-randomised controlled trial.	2018	https://dx.doi.org/10.1016/j.maturitas.2018.01.007
Embase	Using a therapeutic companion robot for dementia symptoms in long-term care: reflections from a cluster-RCT.	2019	https://dx.doi.org/10.1080/13607863.2017.1421617

N.B. These documents automatically identified may not have been verified by the study sponsor.

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