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Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.
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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 information initially 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
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Scientific title
The effect of the companion robot Paro on behavioural and psychological outcomes in people with dementia and their carers
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Secondary ID [1]
286344
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Nil known
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Universal Trial Number (UTN)
U1111-1168-1996
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Caregiver burden and quality of life
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Condition category
Condition code
Neurological
294771
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
291401
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Treatment: Devices
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Intervention code [2]
291402
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Agitation as measured by the Neuropsychiatric Inventory, Cohen-Mansfield Agitation Index, observations of behaviour during sessions
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Timepoint [1]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Primary outcome [2]
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Caregiver burden as measured by the Zarit Burden Interview
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Timepoint [2]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [1]
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Caregiver quality of life as measure by the World Health Organisation Quality of Life Questionnaire
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Timepoint [1]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [2]
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Cortisol from both patients and their caregivers as measured by salivary and hair cortisol samples, respectively.
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Timepoint [2]
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Hair cortisol will be taken from caregivers at baseline and 6 weeks after intervention commencement.
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Secondary outcome [3]
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Patient's cognitive functioning as measured by Addenbrooke's Cognitive Examination-III (ACE-III)
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Timepoint [3]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [4]
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Patient's level of depression as measured by the Cornell Scale of Depression in Dementia (CSDD)
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Timepoint [4]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [5]
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Patient and caregiver blood pressure measurements as measured using a digitial blood pressure monitor
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Timepoint [5]
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Baseline, and at 6 and 12 weeks after intervention commencement. Also before and after control and intervention sessions for individuals with dementia.
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Secondary outcome [6]
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Caregiver perceived stress as measured by the Perceived Stress Scale
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Timepoint [6]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [7]
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Perceived respect (Question designed specifically for this study: How much do you feel the care recipient treats you with respect)
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Timepoint [7]
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Baseline, and at 6 and 12 weeks after intervention commencement
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Secondary outcome [8]
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Alpha amylase from saliva samples
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Timepoint [8]
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Before and after control and intervention sessions for individuals with dementia.
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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
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Minimum age
16
Years
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
physically unable to interact with Paro
Non-English speaker
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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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
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint(s)
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/03/2015
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Actual
20/03/2015
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Date of last participant enrolment
Anticipated
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Actual
9/06/2015
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Date of last data collection
Anticipated
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Actual
30/09/2015
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Auckland Faculty Research Development Fund
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Address [1]
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Physical address:
FMHS Research Office
Administration
Level 1, Building 505
85 Park Road
Grafton
Postal Address:
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
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Country [1]
290918
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New Zealand
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Primary sponsor type
Individual
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Name
Elizabeth Broadbent
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Address
AUCKLAND HOSPITAL
Level 12, Room 599-12005
PARK ROAD
Auckland 1023
GRAFTON
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Chih-Hsin Liang
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Address [1]
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AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
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Country [1]
289601
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New Zealand
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Other collaborator category [1]
278393
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Individual
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Name [1]
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Bruce MacDonald
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Address [1]
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UNIVERSITY OF AUCKLAND
903
Level 3, Room 903-342
368 KHYBER PASS
Auckland 1023
NEWMARKET
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Country [1]
278393
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New Zealand
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Other collaborator category [2]
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Individual
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Name [2]
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Dr. Mark Fisher
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Address [2]
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Clinical Head / Consultant Psychiatrist
Koropiko – Mental Health Services for Older People Memory Team
ECT Service
Middlemore Hospital, Otahuhu
Private Bag 93311, Auckland 1640
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Country [2]
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New Zealand
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Other collaborator category [3]
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Individual
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Name [3]
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Isabell Piroth
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Address [3]
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AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
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Country [3]
278400
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Auckland Human Participants Ethics Committee
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Ethics committee address [1]
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Post Award Services
Research Office
Level 10, Building 620
49 Symonds Street
Grafton
Auckland 1010
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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24/09/2014
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Approval date [1]
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18/11/2014
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Ethics approval number [1]
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013067
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Summary
Brief summary
The primary purpose of the study is to further investigate the benefits of the companion robot, Paro, for people with dementia.
The specific objectives are:
-To investigate whether interacting with companion robots can reduce cognitive, functional, depressive, and behavioural problems in people with dementia.
-To investigate whether companion robots can reduce caregiver stress.
-To investigate whether interacting with companion robots can reduce stress hormones in people with dementia and their caregivers.
-To investigate whether companion robots can reduce the need for medication in people with dementia.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
348
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http://www.anzctr.org.au/AnzctrAttachments/368163-Ethics Approval Letter.pdf
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Contacts
Principal investigator
Name
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Dr Elizabeth Broadbent
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Address
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AUCKLAND HOSPITAL
Level 12, Room 599-12005
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
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Country
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New Zealand
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Phone
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+64 9 923 6756
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Fax
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Email
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e.broadbent@auckland.ac.nz
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Contact person for public queries
Name
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Miss Chih-Hsin (Amy) Liang
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Address
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AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
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Country
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New Zealand
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Phone
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+642102298861
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Fax
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Email
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clia679@aucklanduni.ac.nz
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Contact person for scientific queries
Name
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Miss Chih-Hsin (Amy Liang)
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Address
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AUCKLAND HOSPITAL
Level 12, Room 599-12004
PARK ROAD
Auckland 1023
GRAFTON
New Zealand
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Country
55712
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New Zealand
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Phone
55712
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+642102298861
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Fax
55712
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Email
55712
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clia679@aucklanduni.ac.nz
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
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How or where can supporting documents be obtained?
Type [1]
402
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Study protocol
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Citation [1]
402
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Link [1]
402
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Email [1]
402
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Other [1]
402
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Attachment [1]
402
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http://www.anzctr.org.au/Steps11and12/368163-(Uploaded-22-11-2018-11-27-27)-Study-related document.pdf
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Type [2]
403
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Ethical approval
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Citation [2]
403
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Link [2]
403
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Email [2]
403
0
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Other [2]
403
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Attachment [2]
403
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http://www.anzctr.org.au/Steps11and12/368163-(Uploaded-22-11-2018-11-28-40)-Study-related document.pdf
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Type [3]
404
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Informed consent form
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Citation [3]
404
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Link [3]
404
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Email [3]
404
0
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Other [3]
404
0
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Attachment [3]
404
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http://www.anzctr.org.au/Steps11and12/368163-(Uploaded-22-11-2018-11-29-31)-Study-related document.doc
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Summary results
Have study results been published in a peer-reviewed journal?
Yes
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Journal publication details
Publication date and citation/details [1]
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Liang, A., Piroth, I., Robinson, H., MacDonald, B., Fisher, M., Nater, U. M., ... & Broadbent, E. (2017). A Pilot Randomized Trial of a Companion Robot for People With Dementia Living in the Community. Journal of the American Medical Directors Association, 18(10), 871-878
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Attachments [1]
888
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Other publications
Have study results been made publicly available in another format?
No
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Results – basic reporting
http://www.anzctr.org.au/Steps11and12/368163-(Uploaded-22-11-2018-12-20-17)-Basic results summary.pdf
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Results – plain English summary
The aim of the study was to explore how people with dementia responded to Paro in a home and day care environment.
We recruited a total of 30 dyads of care recipients with dementia who attended dementia day care and their informal caregivers.
Care recipients in the Paro group showed significantly more positive facial expressions, they also talked more to staff and researchers compared to those in the control group. Based on further analyses of the results, it was found that participants with less severe cognitive impairment seemed to interact more positively with Paro. However, we found that Paro had limited effects in improving care recipient symptoms, medication usage and caregiver well-being. Paro did not change blood pressure or cortisol levels. Some caregivers reported that Paro was soothing, reduced anxiety and improved the mood for the individual with dementia. The participants with dementia showed variable responses to Paro, some people were very responsive to Paro, whereas others did not pay much attention.
The findings suggest that Paro has potential as a personalised approach for enhancing the mood and social well-being of individuals with dementia. Paro presents an additional option for day care activities. Paro’s use in a home environment depends on caregivers’ personal preferences and availability.
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