Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000958987
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 for people living independently in a retirement village?
Scientific title
Can robots improve quality of life for people aged over 65 years living independently in a retirement village?
Secondary ID [1] 262992 0
Nil
Universal Trial Number (UTN)
U1111-1124-3339
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 270723 0
Quality of life in people living independently in a retirement village 270728 0
Condition category
Condition code
Mental Health 270898 270898 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 270903 270903 0 0
Depression
Public Health 270904 270904 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A robot is to be placed in the apartment of each resident for 2 months. Depending on the needs of the participant, the robot can do:medication management, blood pressure reading, telecommunication (with relatives, friends, staff), brain fitness software, show videos and photos, lifetime health diary (shows health records), and give access to web content such as information about the retirement village. The participants can use the robot at their discretion. THere is a washout period of three weeks. THis is in addition to standard care.
Intervention code [1] 269340 0
Treatment: Devices
Comparator / control treatment
no robot - standard care. Residents in independent living facilities are independent and do not receive extra care on a regular basis.
Control group
Active

Outcomes
Primary outcome [1] 279572 0
Quality of life (SF12)
Timepoint [1] 279572 0
2 months follow-up
Secondary outcome [1] 287931 0
depression - Geriatirc Depression Scale
Timepoint [1] 287931 0
2 months follow-up
Secondary outcome [2] 287932 0
adherence _ Medication Adherence Report Scale
Timepoint [2] 287932 0
2 months follow-up
Secondary outcome [3] 287933 0
perceptions of robots (robot attitude scale, mind perception scale)
Timepoint [3] 287933 0
2 months follow-up

Eligibility
Key inclusion criteria
age over 65 years
must reside in independent living facilities at Selwyn Village Retirement Centre
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
too unwell to participate
unable to understand English

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)
allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 3827 0
New Zealand
State/province [1] 3827 0
Auckland

Funding & Sponsors
Funding source category [1] 269803 0
Government body
Name [1] 269803 0
Foundation of Research Science and Technology (now Ministry of Science and Innovation)
Country [1] 269803 0
New Zealand
Funding source category [2] 269804 0
Government body
Name [2] 269804 0
International Testbed Project Ministry of Knowledge Economy
Country [2] 269804 0
Korea, Democratic People's Republic Of
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 268839 0
None
Name [1] 268839 0
Address [1] 268839 0
Country [1] 268839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271767 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 271767 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 271767 0
New Zealand
Date submitted for ethics approval [1] 271767 0
Approval date [1] 271767 0
01/09/2011
Ethics approval number [1] 271767 0

Summary
Brief summary
This project aims to investigate whether robots can improve quality of life for people in a retirement village. This trial is a cross-over randomized controlled trial with 26 independent living residents with their own robot in their apartment. The robots can take blood pressure, remind about taking medication, provide entertainment and brain fitness games. They can also provide information about activities at
the village. The outcome measures are resident quality of life, depression, adherence to medication, and perceptions of the robots, after 2 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33120 0
Address 33120 0
Country 33120 0
Phone 33120 0
Fax 33120 0
Email 33120 0
Contact person for public queries
Name 16367 0
Ben Robins
Address 16367 0
Uniservices, Private Bag, 92019 AMC,
Auckland 1142, New Zealand
Country 16367 0
New Zealand
Phone 16367 0
+64 21 190 1429
Fax 16367 0
Email 16367 0
[email protected]
Contact person for scientific queries
Name 7295 0
Liz Broadbent
Address 7295 0
Dept Psychological Medicine
Faculty Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 7295 0
New Zealand
Phone 7295 0
+64 9 3737599
Fax 7295 0
Email 7295 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.