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Trial registered on ANZCTR


Registration number
ACTRN12615000295549
Ethics application status
Approved
Date submitted
18/03/2015
Date registered
31/03/2015
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Date results provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a companion robot for people with dementia and their carers
Scientific title
The effect of the companion robot Paro on behavioural and psychological outcomes in people with dementia and their carers
Secondary ID [1] 286344 0
Nil known
Universal Trial Number (UTN)
U1111-1168-1996
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 294466 0
Caregiver burden and quality of life 294467 0
Condition category
Condition code
Neurological 294771 294771 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paro is a Japanese robot designed to have the positive effects of a pet without the demands. Paro is an advanced interactive robot developed by the Intelligent Systems Research Institute (ISRI), a leading Japanese industrial automation pioneer. Paro is modelled after a baby Canadian harp seal and is covered in white artificial fur. It weighs approximately 2.5 kg. Paro has four senses; sight, sound, balance, and touch meaning that Paro responds to contact, as well as to other stimuli in its environment by moving or imitating the noises of a baby harp seal. Paro operates by using the three elements; its internal states, sensory information from its sensors and its own diurnal rhythm to carry out various activities during its interaction with people.
Companion robots such as Paro draw on the principles of animal therapy and research conducted predominantly in Japan has found that Paro improves patient’s moods, facilitates social interactions and in general leads to higher quality of life for people in retirement care, particularly those with dementia.

We propose to conduct a randomized controlled trial with 30 participants and their caregivers at an aged-care facility with eleven Paro robots to investigate effects on behavioural, neuroendocrine, social and psychological outcomes. Participants will be randomly assigned to the control group or to the Paro group using a random list generator. Participants in the intervention group will interact with the robots over 3 months, in small groups at the care facility and individually, at home. Paro group sessions will consist of a maximum of four residents to one Paro robot, which has been found to be the optimum group size.

Two researchers will run 1 hour daily sessions with Paro at the daycare centre, as participants attend the daycare on various days of the week, it is expected that participants will interact with Paro between 1-3 hours per week. In addition, participants will be given the option of taking Paro home, where Paro will be available to participants 24/7, to use when needed.
The interaction sessions will involve verbal communication, patting and playing with Paro. The researchers will monitor sessions with Paro and also provide instruction to caregivers concerning how to use Paro. Adherence to sessions will be monitored by researchers taking a register of participant attendance.


Intervention code [1] 291401 0
Treatment: Devices
Intervention code [2] 291402 0
Behaviour
Comparator / control treatment
Participants in the control group will partake in normal activities as scheduled by the aged care facility. Normal activities typically involve school children visits, games and crafts sessions.
Control group
Active

Outcomes
Primary outcome [1] 294525 0
Agitation as measured by the Neuropsychiatric Inventory, Cohen-Mansfield Agitation Index, observations of behaviour during sessions
Timepoint [1] 294525 0
Baseline, and at 6 and 12 weeks after intervention commencement
Primary outcome [2] 294526 0
Caregiver burden as measured by the Zarit Burden Interview
Timepoint [2] 294526 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 313564 0
Caregiver quality of life as measure by the World Health Organisation Quality of Life Questionnaire
Timepoint [1] 313564 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [2] 313567 0
Cortisol from both patients and their caregivers as measured by salivary and hair cortisol samples, respectively.
Timepoint [2] 313567 0
Hair cortisol will be taken from caregivers at baseline and 6 weeks after intervention commencement.
Secondary outcome [3] 313568 0
Patient's cognitive functioning as measured by Addenbrooke's Cognitive Examination-III (ACE-III)
Timepoint [3] 313568 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [4] 313569 0
Patient's level of depression as measured by the Cornell Scale of Depression in Dementia (CSDD)
Timepoint [4] 313569 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [5] 313658 0
Patient and caregiver blood pressure measurements as measured using a digitial blood pressure monitor
Timepoint [5] 313658 0
Baseline, and at 6 and 12 weeks after intervention commencement. Also before and after control and intervention sessions for individuals with dementia.
Secondary outcome [6] 313752 0
Caregiver perceived stress as measured by the Perceived Stress Scale
Timepoint [6] 313752 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [7] 315118 0
Perceived respect (Question designed specifically for this study: How much do you feel the care recipient treats you with respect)
Timepoint [7] 315118 0
Baseline, and at 6 and 12 weeks after intervention commencement
Secondary outcome [8] 315119 0
Alpha amylase from saliva samples
Timepoint [8] 315119 0
Before and after control and intervention sessions for individuals with dementia.

Eligibility
Key inclusion criteria
Individuals who have attended the Selwyn Foundation dementia daycare Anchorage unit for at least 3 months and their caregivers
Fluent in English
Informed consent must be obtained
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
physically unable to interact with Paro
Non-English speaker

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)
Selwyn Foundation have a list of all the people who attend dementia daycare. Letters will be sent to the caregivers by Selwyn Foundation to invite them and their relative with dementia to participate in the study. They will also be contacted either face to face or by telephone to ask if they and their relative would be interested in taking part.
If they are interested in participating researchers will obtain written informed consent. As people with dementia are unable to give informed consent, consent will be obtained from the caregiver as their enduring power of attorney.

Participants will be randomly assigned to the control group or to the Paro group using a random list generator. On an average day at the centre there will be about 4 people in the control group and 4 in the intervention group.

Allocation concealment will be ensured through delivery of randomisation using sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random list generator created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
We previously found an effect size d=1.15 of Paro on social behaviour in rest home and hospital residents. Using a two-tailed t-test, choosing d=1.15, alpha = .05 and power of .80, we would need 13 participants in each group.

ANCOVAs will be performed to compare changes between baseline and follow-up measures of each of the outcome measures with corresponding baseline scores entered as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2015
Actual
20/03/2015
Date of last participant enrolment
Anticipated
Actual
9/06/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 6748 0
New Zealand
State/province [1] 6748 0
Auckland

Funding & Sponsors
Funding source category [1] 290918 0
University
Name [1] 290918 0
University of Auckland Faculty Research Development Fund
Country [1] 290918 0
New Zealand
Primary sponsor type
Individual
Name
Elizabeth Broadbent
Address
AUCKLAND HOSPITAL
Level 12, Room 599-12005
PARK ROAD
Auckland 1023
GRAFTON
Country
New Zealand
Secondary sponsor category [1] 289601 0
Individual
Name [1] 289601 0
Chih-Hsin Liang
Address [1] 289601 0
AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
Country [1] 289601 0
New Zealand
Other collaborator category [1] 278393 0
Individual
Name [1] 278393 0
Bruce MacDonald
Address [1] 278393 0
UNIVERSITY OF AUCKLAND
903
Level 3, Room 903-342
368 KHYBER PASS
Auckland 1023
NEWMARKET
Country [1] 278393 0
New Zealand
Other collaborator category [2] 278399 0
Individual
Name [2] 278399 0
Dr. Mark Fisher
Address [2] 278399 0
Clinical Head / Consultant Psychiatrist
Koropiko – Mental Health Services for Older People Memory Team
ECT Service
Middlemore Hospital, Otahuhu
Private Bag 93311, Auckland 1640
Country [2] 278399 0
New Zealand
Other collaborator category [3] 278400 0
Individual
Name [3] 278400 0
Isabell Piroth
Address [3] 278400 0
AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
Country [3] 278400 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292522 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 292522 0
Ethics committee country [1] 292522 0
New Zealand
Date submitted for ethics approval [1] 292522 0
24/09/2014
Approval date [1] 292522 0
18/11/2014
Ethics approval number [1] 292522 0
013067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 348 348 0 0
/AnzctrAttachments/368163-Ethics Approval Letter.pdf

Contacts
Principal investigator
Name 55710 0
Dr Elizabeth Broadbent
Address 55710 0
AUCKLAND HOSPITAL
Level 12, Room 599-12005
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
Country 55710 0
New Zealand
Phone 55710 0
+64 9 923 6756
Fax 55710 0
Email 55710 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 55711 0
Chih-Hsin (Amy) Liang
Address 55711 0
AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
Country 55711 0
New Zealand
Phone 55711 0
+642102298861
Fax 55711 0
Email 55711 0
clia679@aucklanduni.ac.nz
Contact person for scientific queries
Name 55712 0
Chih-Hsin (Amy Liang)
Address 55712 0
AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
Country 55712 0
New Zealand
Phone 55712 0
+642102298861
Fax 55712 0
Email 55712 0
clia679@aucklanduni.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
402Study protocol    368163-(Uploaded-22-11-2018-11-27-27)-Study-related document.pdf
403Ethical approval    368163-(Uploaded-22-11-2018-11-28-40)-Study-related document.pdf
404Informed consent form    368163-(Uploaded-22-11-2018-11-29-31)-Study-related document.doc



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.