Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000029594
Ethics application status
Approved
Date submitted
7/10/2014
Date registered
19/01/2015
Date last updated
19/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Smarter, Safer Homes for the Ageing and Disabled Person Pilot Study to investigate the feasibility, acceptance, usage and impact of providing a smart home platform with environmental sensors and mobile techniques to facilitate safe living of older and disabled Australians.
Scientific title
Smarter, Safer Homes for the Ageing and Disabled Person Pilot Study aims at assessing the viability of CSIRO's Smarter Safer Homes (SSH) platform to support both aged and young people with physical disability to live independently longer at home, to assist service providers' decision making for individualised care planning for timely intervention.
Secondary ID [1] 285434 0
None
Universal Trial Number (UTN)
Trial acronym
SSHAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Monitoring and deriving relevant information of health status in elderly participants/young people with disability to enable independent living and support from family/relative or health care provider 293193 0
Condition category
Condition code
Public Health 293468 293468 0 0
Health service research

Intervention/exposure
Study type
Interventional
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 12 months.

Participants are encouraged to do regular measurements of their body weight, blood pressure, body temperature, and blood glucose (only when necessary) at least once per week. They can do these measurements by themselves, or clinical/nursing staff from our trial collaborators can arrange weekly visits to help them do these measurements. All measurements will be automatically uploaded to our data server, with no requirements of participants' manually inputs.

The system also provides a courtesy videoconference module that only intends to provide another way for participants to communicate with their family members, and/or healthcare providers. We will not use this module to communicate with participants. However we do record number of usages of this videoconference module as an index of their activity level of social connectivity for their self-monitor purpose.

Environmental sensors are:
*Motion sensor – detects indoor movements
*Power sensor – detects power usages of electrical appliances
*Contact sensor – detects open/close of doors including front/back doors, fridge
*Temperature/humidity – detects changes in temperature or humidity in bathroom or kitchen
*Accelerometer – detect movements on beds, such as tossing and turning during sleep
Medical devices are:
*AND UA-321PBT scale – measures human body weight
*AND UA-767PBT – measures blood pressure
*Myglucohealth Glucometer – measures blood glucose level
*Tunstall Ear thermometer - measures body temperature
Information from sensors will be collected and made available to participants for a period of 12 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] 290367 0
Other interventions
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293291 0
Independent living scales or Activities of Daily Living (ADL) (Mobility, Meal, Hygiene, Transfer, Dress) assessed through tools including Katz index (for ageing people) and Barthel Index (for disabled people)
Timepoint [1] 293291 0
6 and 12 months
Secondary outcome [1] 311065 0
Develop methods to recognise and identify individual activity profile(s) in multi-resident homes through sensors, which will be assessed by comparing against routine activity data such as indoor movements, sit/stand postural transfer, bed time, collected through wearable sensors (such as bluetooth tag, accelerometer sensors), and meal preparation, shower taking, shopping collected by the "daily routine questionnaire".
Timepoint [1] 311065 0
6 to 12 months

Eligibility
Key inclusion criteria
Over 65 years of age or under 65 years of age with disability, have an Internet Service Provider (ISP) connection to broadband internet, are living independently or intend to live independently, and require no home care support.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Live in an aged care facility; have constant 24 hr/7 day a week nursing support; are residents of nursing home facility, no internet access; unwilling to utilise a touch screen device for connectivity. Pre-existing diagnosed condition with compromised cognition or previous early on-set of dementia

Study design
Purpose of the study
Prevention
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)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
1/10/2014
Date of last participant enrolment
Anticipated
31/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290041 0
Government body
Name [1] 290041 0
Australian eHealth Research Centre, CSIRO
Country [1] 290041 0
Australia
Primary sponsor type
Government body
Name
CSIRO Digital Productivity Flagship
Address
Level 5
UQ Health Sciences Building
901/16 Royal Brisbane and Women's Hospital HERSTON
QLD 4029
Country
Australia
Secondary sponsor category [1] 288732 0
None
Name [1] 288732 0
Address [1] 288732 0
Country [1] 288732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291766 0
CSIRO Food and Nutrition Flagship Human Research Ethics Committee
Ethics committee address [1] 291766 0
Ethics committee country [1] 291766 0
Australia
Date submitted for ethics approval [1] 291766 0
20/08/2014
Approval date [1] 291766 0
26/09/2014
Ethics approval number [1] 291766 0
2014/12

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

Contacts
Principal investigator
Name 51870 0
Dr Qing Zhang
Address 51870 0
CSIRO Digital Productivity Flagship, The Australian eHealth Research centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country 51870 0
Australia
Phone 51870 0
61 7 3253 3630
Fax 51870 0
Email 51870 0
[email protected]
Contact person for public queries
Name 51871 0
Qing Zhang
Address 51871 0
CSIRO Digital Productivity Flagship, The Australian eHealth Research centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country 51871 0
Australia
Phone 51871 0
61 7 3253 3630
Fax 51871 0
Email 51871 0
[email protected]
Contact person for scientific queries
Name 51872 0
Qing Zhang
Address 51872 0
CSIRO Digital Productivity Flagship, The Australian eHealth Research centre, Level 5, UQ Health Sciences Building 901/16, Royal Brisbane and Women's Hospital, Herston QLD 4029
Country 51872 0
Australia
Phone 51872 0
61 7 3253 3630
Fax 51872 0
Email 51872 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.