Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000469819
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
30/04/2012
Date last updated
29/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can the companion robot Paro improve quality of life in a residential care facility: A randomised controlled trial
Scientific title
Can the companion robot Paro improve quality of life in a residential care facility: A randomised controlled trial
Secondary ID [1] 280361 0
Nil
Universal Trial Number (UTN)
U1111-1130-0683
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Life in a residental care facility 286333 0
Depression in older people 286334 0
Loneliness in older people 286335 0
Condition category
Condition code
Mental Health 286579 286579 0 0
Depression
Public Health 286635 286635 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paro is a robotic fluffy seal designed to act like an animal. Paro was designed to be used in a similar way to live animals during animal therapy in elder care facilities. The intervention group has two 1 hour group sessions run by a caregiver with Paro each week for 12 weeks where each resident has the chance to interact with Paro and discuss the robot with others in the group. Caregivers have also been trained to use Paro with those in the group outside of activity sessions if a resident is upset
Intervention code [1] 284728 0
Other interventions
Comparator / control treatment
Participants randomised to the control group will have other activities provided by the residential care facility during the Paro intervention. Other activites that may be implemented are outings for residents and quizes and discussions in other parts of the rest home. As Paro will not be avaliable for use with the control group if a resident is upset standard care will be provided. Standard care means that staff members will try and calm residents by talking to them in a one on one situation and trying to find out the cause of the problem
Control group
Active

Outcomes
Primary outcome [1] 287003 0
Changes in quality of life as mesured by both proxy ratings of QoL-AD and resident ratings on the QoL-AD.
Timepoint [1] 287003 0
Baseline and at the end of the trial (12 weeks later)
Secondary outcome [1] 297180 0
Changes in depression as measured by the Geriatric Depression Scale
Timepoint [1] 297180 0
Baseline and at the end of the trial (12 weeks later)
Secondary outcome [2] 297181 0
Changes in loneliness as measured by the UCLA Loneliness Scale (Version 3)
Timepoint [2] 297181 0
Baseline and at the end of the trial (12 weeks later)
Secondary outcome [3] 297182 0
Attachment to Paro will be measured with the Comfort from Companionship Animal Scale
Timepoint [3] 297182 0
At the end of the trial (12 weeks after the intervention begins)

Eligibility
Key inclusion criteria
Residents living in the resthome or the hospital at Selwyn Heights Residential Care Facility in Auckland, New Zealand and identified by the management care staff as suitable participants
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Participants enrolled in the trial were allocated an ID number. A randomised list was generated by a computer and each ID number was assigned to either Paro intervention or control group as determined by the list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the website http://www.random.org/lists/ a randomised list was generated which was then was used to allocate residents into each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4272 0
New Zealand
State/province [1] 4272 0
Auckland

Funding & Sponsors
Funding source category [1] 285140 0
University
Name [1] 285140 0
University of Auckland
Country [1] 285140 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 284040 0
None
Name [1] 284040 0
Address [1] 284040 0
Country [1] 284040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287156 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 287156 0
Research Integrity Unit
Level 10, Building 620
49 Symonds Street,
Auckland, 1010
Ethics committee country [1] 287156 0
New Zealand
Date submitted for ethics approval [1] 287156 0
Approval date [1] 287156 0
01/09/2011
Ethics approval number [1] 287156 0
University of Auckland Ethics Committee number 7461

Summary
Brief summary
To evaluate the benefits of the companion robot Paro for use at an residential care facility. By randomly assigning residents to a control group or an intervention group where participant use Paro over 12 weeks the benefits of the robot on well being can be assessed over this period. It is expected that the robot will improve quality of life, reduce depression and loneliness over this time in comparison to residents who have no contact with the robot
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34091 0
Address 34091 0
Country 34091 0
Phone 34091 0
Fax 34091 0
Email 34091 0
Contact person for public queries
Name 17338 0
Elizabeth Broadbent
Address 17338 0
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 17338 0
New Zealand
Phone 17338 0
+64 9 373 7599 extn 86756
Fax 17338 0
+ 64 9 373 7013
Email 17338 0
[email protected]
Contact person for scientific queries
Name 8266 0
Elizabeth Broadbent
Address 8266 0
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 8266 0
New Zealand
Phone 8266 0
+64 9 373 7599 extn 86756
Fax 8266 0
+ 64 9 373 7013
Email 8266 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
SourceTitleYear of PublicationDOI
EmbasePhysiological effects of a companion robot on blood pressure of older people in residential care facility: a pilot study.2015https://dx.doi.org/10.1111/ajag.12099
N.B. These documents automatically identified may not have been verified by the study sponsor.