Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000959976
Ethics application status
Approved
Date submitted
6/09/2011
Date registered
7/09/2011
Date last updated
8/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Can robots improve quality of life in residents and staff in a residential care facility?
Scientific title
Can robots improve quality of life in residents aged over 65 years and staff in a residential care facility?
Secondary ID [1] 262993 0
nil
Universal Trial Number (UTN)
U1111-1124-3416
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 270724 0
Quality of life in residents of a residential care facility 270726 0
Quality of life in staff at a residential care facility 270727 0
Condition category
Condition code
Mental Health 270900 270900 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 270902 270902 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 robots will be placed in each of two buildings at the residential care facility. THe robots can measure vital signs (blood pressure, pulse oximetry, blood glucose), telecommunication (with family, friends, staff), brain fitness software and entertainment (show videos, photos), lifetime health diary (shows health records), and access to web based content (such as whats on at the retirement village that day). Staff and residents are free to use the robots at thier discretion. THe robots will be there for 4 months. This will be in addition to the standard care that is normally provided to the individuals at the residential care faciliity.
Intervention code [1] 269341 0
Treatment: Devices
Comparator / control treatment
no robot - standard care, that is care normally provided to the individual at the residential care facility.
Control group
Active

Outcomes
Primary outcome [1] 279573 0
quality of life (measure with SF12 (staff) or QOL-AD (residents)
Timepoint [1] 279573 0
4 months follow-up
Secondary outcome [1] 287934 0
depression - geriatric depression scale in residents only
Timepoint [1] 287934 0
4 months follow-up
Secondary outcome [2] 287935 0
job satisfaction and job morale for staff only thorugh self report qquestionnaires: Job Satisfaction Scale and Job Morale Scale
Timepoint [2] 287935 0
4 months follow-up

Eligibility
Key inclusion criteria
living or working in residential care (hospitals or rest homes) at Selwyn Village retirement centre (not independent apartments or villas)
residents must be over 65 years
Staff must be over 16 years
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Don't understand English
Too unwell to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment outside Australia
Country [1] 3828 0
New Zealand
State/province [1] 3828 0
Auckland

Funding & Sponsors
Funding source category [1] 269805 0
Government body
Name [1] 269805 0
Foundation of Research Science and Technology (now called Ministry of Science and Innovation)
Country [1] 269805 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 268840 0
None
Name [1] 268840 0
Address [1] 268840 0
Country [1] 268840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271768 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 271768 0
Ethics committee country [1] 271768 0
New Zealand
Date submitted for ethics approval [1] 271768 0
Approval date [1] 271768 0
01/09/2011
Ethics approval number [1] 271768 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33121 0
Address 33121 0
Country 33121 0
Phone 33121 0
Fax 33121 0
Email 33121 0
Contact person for public queries
Name 16368 0
Ben Robins
Address 16368 0
Uniservices, Private Bag, 92019 AMC,
Auckland 1142, New Zealand
Country 16368 0
New Zealand
Phone 16368 0
+64 21 190 1429
Fax 16368 0
Email 16368 0
[email protected]
Contact person for scientific queries
Name 7296 0
Liz Broadbent
Address 7296 0
Dept of Psychological Medicine, The University of Auckland, FMHS, Private Bag, 92019 AMC,
Auckland 1142, New Zealand
Country 7296 0
New Zealand
Phone 7296 0
+64 9 3737599
Fax 7296 0
Email 7296 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
No additional documents have been identified.