Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000829213p
Ethics application status
Submitted, not yet approved
Date submitted
22/02/2018
Date registered
16/05/2018
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Smarter Safer Homes to support elderly living in their own homes through enhanced care models
Scientific title
Determining the effect of applying Smarter Safer Home technology to support elderly living on Quality of Life and Quality of care
Secondary ID [1] 294138 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health service utilisation 306764 0
Falls 307318 0
Malnutrition 307319 0
Depression 307320 0
Condition category
Condition code
Public Health 306037 306037 0 0
Health service research
Diet and Nutrition 306426 306426 0 0
Other diet and nutrition disorders
Injuries and Accidents 306427 306427 0 0
Other injuries and accidents
Mental Health 306428 306428 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) All participants assigned to the intervention group will receive the CSIRO Smarter Safer Homes (SSH) kit. The SSH Kit includes a tablet with the pre-installed SSH app (can be downloaded at Apple store), and a set of wireless sensors to be deployed in home. These sensors are all passive environmental sensors that collect participants' in-home actions as sensor data. The sensor data will be uploaded to CSIRO server and used to infer the participants' daily activities by the CSIRO AI engine. And finally, the computed info will be communicated to participants through the SSH app.
b) The duration of the intervention is 12 months;
c) The study will be conducted in partnership with four Aged Care Providers, Anglicare, Integrated living, All about Living and starAged living. Aged care services staff will identify potentially eligible participants, conduct interviews and provide consultation and helps during the intervention period
d) To monitor participants' adherence to the intervention, we will take two strategies:
i) the SSH server communicate actively to every installed sensor periodically. Therefore, if any sensors are offline, onsite aged care service staff will be noticed to fix the problem
ii) the aged care service staff will also regularly visit participants' homes during the intervention, as part of their normal routines.
iii) Intervention Group participant data will be viewed by Aged Care Provider clinical staff and CSIRO researchers at least once/week to optimise care with efficient utilisation of clinical and care workers.
Intervention code [1] 300428 0
Lifestyle
Comparator / control treatment
The control group will not receive the installation of Smarter Safer Homes platform, and just follow their regular care program.
Control group
Active

Outcomes
Primary outcome [1] 304904 0
Quality of care (ASCOT measure)
Timepoint [1] 304904 0
after 12 months from the trial starting date
Secondary outcome [1] 343564 0
Quality of life (EQ5D 5-L survey)
Timepoint [1] 343564 0
after 12 months from the trial starting date
Secondary outcome [2] 344063 0
Changes in service design, adoption and aged care provider experiences (trial specific survey/semi-structured interviews)
Timepoint [2] 344063 0
after 12 months from the trial starting date
Secondary outcome [3] 344990 0
Activities of daily living (though Katz ADL and Lawton ADL). This is a composite outcome by combining results from Katz ADL scale and Lawton ADL scale. Actually Lawton ADL scale is a superset of Katz ADL scale but is mainly used to measure seniors ability of independent living in a community.
Timepoint [3] 344990 0
after 12 months from the trial starting date
Secondary outcome [4] 344991 0
Depression in elderly living independently in their own homes (through Geriatric Depression Scale)
Timepoint [4] 344991 0
after 12 months from the trial starting date
Secondary outcome [5] 344992 0
Carer burden (informal carers) (through the 4-item Zarit Screen)
Timepoint [5] 344992 0
after 12 months from the trial starting date
Secondary outcome [6] 344993 0
Health service utilisation including unscheduled visits to hospital, to GPs and Nurse visits. (through analysis of Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), Queensland Health Linkage Data and ED data sources)
Timepoint [6] 344993 0
after 12 months from the trial starting date
Secondary outcome [7] 344994 0
costs effectiveness (through assessing costs borne to aged care providers and trial participants as a result of the deployment of the SSH platform, specifically we use cost utility from Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS), and hospital data )
Timepoint [7] 344994 0
after 12 months from the trial starting date

Eligibility
Key inclusion criteria
* Aged 65 years and older
*.In the care of a designated Aged Care Service Provider
* English speaking, proficiency in written English
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*. People residing in long term residential care
*. Not able to give independent consent due to reasons such as severe cognitive impairment (must give informed consent)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Participants will include 200 individuals, aged 65 years and older, of three Local Government Areas in Queensland, Australia, recruited from four Aged Care Service Providers:
* Metropolitan area (120 participants, from Anglicare and All about living)
* Regional area (60 participants, from Anglicare and integrated living)
* Rural and remote area (20 participants, from Anglicare and star aged living)
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
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
Power was based on a cluster randomised trial design with a clinically important difference of 10% on the primary outcome of ASCOT with standard deviation 0.16 based on previous research. A small intra class coefficient of 0.05 was appropriate as participants live in their own homes and previous research suggests a service provider has a small effect. With ten people per cluster, ICC of 0.05, power of 0.8, a total of 100 people per group will be required.

We do not anticipate a large number of withdrawals. Also repeated measures increases the power of the study to find a significant result and appropriate statistical techniques will be applied to ensure all data available is used in the analyses. Therefore we do not expect that an expected small number of withdrawals will affect the study power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298774 0
Government body
Name [1] 298774 0
Department of Health
Country [1] 298774 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Australian eHealth Research Centre,
Level 5, UQ Health Science Building
Royal Brisbane and Women's Hospital
Herston, 4006, QLD
Country
Australia
Secondary sponsor category [1] 297957 0
None
Name [1] 297957 0
Address [1] 297957 0
Country [1] 297957 0
Other collaborator category [1] 279955 0
Commercial sector/Industry
Name [1] 279955 0
Anglicare
Address [1] 279955 0
439 Ann St, Brisbane City QLD 4000
Country [1] 279955 0
Australia
Other collaborator category [2] 279956 0
Commercial sector/Industry
Name [2] 279956 0
Integrated Living
Address [2] 279956 0
integratedliving Australia Ltd
3 Wilkinson Avenue,
Muswellbrook NSW 2333
Country [2] 279956 0
Australia
Other collaborator category [3] 279957 0
Commercial sector/Industry
Name [3] 279957 0
Star Aged Living
Address [3] 279957 0
14 Brooklands Dr, Beaudesert QLD 4285
Country [3] 279957 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299716 0
CSIRO Health and Medical Human Research ethics Committee
Ethics committee address [1] 299716 0
Ethics committee country [1] 299716 0
Australia
Date submitted for ethics approval [1] 299716 0
12/02/2018
Approval date [1] 299716 0
Ethics approval number [1] 299716 0

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

Contacts
Principal investigator
Name 81366 0
Dr Mohan Karunanithi
Address 81366 0
Australian eHealth Research Centre
Level 5, UQ Health Science Building
Royal Brisbane and Women's Hospital
Herston, 4006, QLD
Country 81366 0
Australia
Phone 81366 0
+61 7 3253 3623
Fax 81366 0
Email 81366 0
mohan.karunanithi@csiro.au
Contact person for public queries
Name 81367 0
Mohan Karunanithi
Address 81367 0
Australian eHealth Research Centre
Level 5, UQ Health Science Building
Royal Brisbane and Women's Hospital
Herston, 4006, QLD
Country 81367 0
Australia
Phone 81367 0
+61 7 3253 3623
Fax 81367 0
Email 81367 0
mohan.karunanithi@csiro.au
Contact person for scientific queries
Name 81368 0
Qing Zhang
Address 81368 0
Australian eHealth Research Centre
Level 5, UQ Health Science Building
Royal Brisbane and Women's Hospital
Herston, 4006, QLD
Country 81368 0
Australia
Phone 81368 0
+61 7 3253 3630
Fax 81368 0
Email 81368 0
qing.zhang@csiro.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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