Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001311741
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
25/11/2013
Date last updated
25/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Smarter Safer Homes for the Ageing Pilot Study to determine the feasibility of using environmental sensor and iPad technologies to facilitate safe independent living for older Australians.
Scientific title
Smarter, Safer Homes for the Ageing Pilot Study using home environmental sensor data to derive a measure of functional independence in healthy elderly independent living people and assess the impact of the solution on their Quality of Life and Family Quality.
Secondary ID [1] 283380 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Monitoring and deriving relevant information of health elderly participants to enable independent living and support from family/relative or health care provider 290058 0
Condition category
Condition code
Public Health 290431 290431 0 0
Health service research
Mental Health 290432 290432 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 290433 290433 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No specific intervention or treatment. All participant homes will have environmental sensors and medical devices installed for health, wellbeing and activity monitoring and a corresponding support tablet PC and application over a period of 6 months.

Environmental sensors are:
*Motion sensor – detects indoor movements
*Power sensor – detects power usages of electrical appliances
*Reed switch – detects open/close of doors including front/back doors, kitchen cabinets, wardrobes
*Temperature/humidity – detects changes in temperature or humidity in bathroom or kitchen
*Circuit meter sensor –detects power usages of kitchen stoves
*Accelerometer – detect movements on beds, such as tossing and turning during sleep
*Acoustic sensor – detect water flows inside kitchen taps
Medical devices are:
*Withings scale – measures human body weight
*FORA D40 – measures blood pressure
*FORA D40 – measures blood glucose level
*Oricom NFS100- measures body temperature

Information from sensors will be collected and made available to participants for a period of 6 months in an easy to understand format on iPads to provide an overview of their health, well-being and activity levels. Furthermore, data will be analysed to assess for correlations with episodes of illness and to determine a new way of scoring daily activity for health and wellbeing monitoring purposes.

A corresponding Internet portal application will be provided to their family, friend or relative assigned by the participant.
Intervention code [1] 287921 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290455 0
Quality of Life of older Australians – staged evaluations to determine the impact of sensory monitoring systems upon wellbeing of individual project participants via qualitative data collected via interview/narratives with participants and quantitative data collected via survey/questionnaire with previous ethics approval.
Timepoint [1] 290455 0
At the beginning (baseline), middle (3 months) and end (6 months) of the project timeframe.
Primary outcome [2] 290456 0
Derivation and the accuracy of corresponding home environmental sensor data to Activities of Daily Living. The outcomes will be accessed using the Katz Activities of Daily Living Scale at 6 month from the trial start.
Timepoint [2] 290456 0
6 months
Primary outcome [3] 290950 0
Family Quality of Life – staged evaluations to determine the wider impact of sensory monitoring systems and their application, upon the wellbeing of family and carers of project participants, utilising qualitative data collected via interview/narratives with nominated family members/carers and quantitative data collected via survey/questionnaire with previous ethics approval. Family members/carers have been nominated by project participants.
Timepoint [3] 290950 0
At final stages of project timeframe (6 months)
Secondary outcome [1] 304549 0
Understanding residents’ perceptions. Qualitative interviews to assess perceptions of monitoring system based on established procedures (eg. Wild et al 2008 J Appll Gerontol 27(2):181-200).
Within the first month, participants will be asked how they feel about each senor/device and if they have any concerns about it. They will then be asked to rate it on a true false scale. They will then be presented with a modified version of Microsoft’s Desirability Toolkit and asked to choose the adjectives that describe their experience with the technology. The interview will be repeated in 6 months with the same questions. Transcripts will undergo content analysis. Scales will undergo quantitative analysis.
Timepoint [1] 304549 0
One month and 6 months.

Eligibility
Key inclusion criteria
*Over 70 years of age
*have an Internet Service Provider (ISP) connection to the National Broadband Network’s high speed broadband
*are living independently
*require no home care support
*has significant others who are not co-located in the same residence but are located in another town, region or location in Australia
*remain in town for the period of the study (up to 18 months - 18 months includes the time from participant enrollment through NBN installation, sensor implementation, testing, 6 months of observation, and follow-up)
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Live in an aged care facility
*have constant 24 hr/7 day a week nursing support
*are living in residences of nursing home facility
*no internet access
*unwilling to utilise a touch screen device for connectivity

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2013
Date of last participant enrolment
Anticipated
Actual
4/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7343 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 287939 0
Government body
Name [1] 287939 0
CSIRO Computational Informatics
Country [1] 287939 0
Australia
Funding source category [2] 287940 0
Government body
Name [2] 287940 0
Australian Centre for Broadband Innovation (ACBI)
Country [2] 287940 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Level 5
UQ Health Sciences Building
901/16 Royal Brisbane and Women's Hospital
HERSTON
QLD 4029
Country
Australia
Secondary sponsor category [1] 286660 0
University
Name [1] 286660 0
University of New England
Address [1] 286660 0
Armidale NSW 2351 Australia
Country [1] 286660 0
Australia
Other collaborator category [1] 277610 0
University
Name [1] 277610 0
The Oregon Center for Aging and Technology (ORCATECH), Oregon Health & Science University (OHSU)
Address [1] 277610 0
3303 SW Bond Ave, Portland, OR 97239 United States
Country [1] 277610 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289868 0
CSIRO Animal, Food and Health Sciences Human Research Ethics Committee
Ethics committee address [1] 289868 0
Ethics committee country [1] 289868 0
Australia
Date submitted for ethics approval [1] 289868 0
12/11/2012
Approval date [1] 289868 0
17/01/2013
Ethics approval number [1] 289868 0
12/17
Ethics committee name [2] 289869 0
UNE Human Research Ethics Committee
Ethics committee address [2] 289869 0
Ethics committee country [2] 289869 0
Australia
Date submitted for ethics approval [2] 289869 0
29/10/2012
Approval date [2] 289869 0
30/11/2012
Ethics approval number [2] 289869 0
HE12-207

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

Contacts
Principal investigator
Name 42846 0
Dr Mohanraj Karunanithi
Address 42846 0
CSIRO Computational Informatics, The Australian E-Health Research Centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029

Country 42846 0
Australia
Phone 42846 0
+61-7-3253 3623
Fax 42846 0
+61-7-3253 3690
Email 42846 0
mohan.karunanithi@csiro.au
Contact person for public queries
Name 42847 0
Qing Zhang
Address 42847 0
CSIRO Computational Informatics, The Australian E-Health Research Centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country 42847 0
Australia
Phone 42847 0
61 7 32533630
Fax 42847 0
Email 42847 0
qing.zhang@csiro.au
Contact person for scientific queries
Name 42848 0
Qing Zhang
Address 42848 0
CSIRO Computational Informatics, The Australian E-Health Research Centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country 42848 0
Australia
Phone 42848 0
61 7 32533630
Fax 42848 0
Email 42848 0
qing.zhang@csiro.au

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.