Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000098932
Ethics application status
Approved
Date submitted
19/12/2019
Date registered
5/02/2020
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assistive technology for people with early dementia
Scientific title
Randomised controlled study of assistive technology on involvement in activities of daily living in people with mild-moderate dementia
Secondary ID [1] 300118 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Dementia-Assist
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild-moderate dementia 315651 0
Condition category
Condition code
Neurological 313940 313940 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Assistive technologies system

Forty intervention patients will be provided with an integrated assistive technologies system comprised of four components:
1. SofiHub reminder hub, which can be remotely programmed by the participant and carers to provide personalised, timed audio reminders for participants to take medications or engage in routine activities of daily living.
2. Up to eight SofiHub infrared sensors, which are placed at strategic locations around the house to identify the location of the participant within their home and their use of medications. These sensors only detect movement and do not record audio or video data.
3. A tablet-based communication system, which allows participants to make immediate video or voice calls to a caregiver, and displays text reminders and messages from carers.
4. A wearable device with an emergency alarm button, which monitors energy expenditure and detects falls, stumbles and near falls.

The assistive technologies system will be installed in participant homes by a technical team from the University of NSW. The study coordinator will be present at installation to assist the person responsible/carer and participant to understand the use and objectives of each technology. Data collection from the assistive technology system is automated and will be displayed on an online portal, accessible to the study coordinator. The intervention will be provided for six months.

The technologies system will provide personalised reminders and alerts to the patients and care network. A 30 minute face-to-face consultation with the participant and his/her carers will be conducted by the study coordinator to determine the specific content and frequency of these reminders, prior to system installation. These will be programmed into the technologies by the study coordinator and ready for use at the time of installation.
Intervention code [1] 316396 0
Lifestyle
Intervention code [2] 316534 0
Treatment: Devices
Comparator / control treatment
Forty participants in the control group will continue to receive usual care, where participants will receive care as supplied in daily practice with no intervention from the researchers.
Control group
Active

Outcomes
Primary outcome [1] 322339 0
Patient involvement in activities of daily living (ADLs) assessed using the Disability Assessment for Dementia (DAD) questionnaire
Timepoint [1] 322339 0
Baseline and six months after commencement of intervention
Secondary outcome [1] 378142 0
Patient depression assessed using the Geriatric Depression Scale
Timepoint [1] 378142 0
Baseline and six months after commencement of intervention
Secondary outcome [2] 378143 0
Caregiver burden assessed using the Zarit Carer Burden Interview
Timepoint [2] 378143 0
Baseline and six months after commencement of intervention
Secondary outcome [3] 378145 0
Number of falls assessed using the Falls and Balance History Questionnaire
Timepoint [3] 378145 0
Baseline and six months after commencement of intervention
Secondary outcome [4] 378722 0
Cognitive impairment assessed using the Mini-Mental State Examination (MMSE)
Timepoint [4] 378722 0
At study enrolment and six months after commencement of intervention
Secondary outcome [5] 378723 0
Patient quality of life assessed using the Dementia Quality of Life Questionnaire
Timepoint [5] 378723 0
Baseline and six months after commencement of intervention

Eligibility
Key inclusion criteria
Diagnosed with mild-moderate dementia or MMSE 10-24,
Living alone or with another person considered frail.
Living in the South Eastern Sydney Local Health District (SESLHD) area.
Experienced one or more falls in the past 12 months.
Willing to give written informed consent to participate and comply with study procedures.
Have an identifiable and consenting person responsible/carer.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents of residential aged care facilities.
Advanced dementia, defined as dependent in at least three basic ADLs or an adjusted MMSE <10.
Non-English speaking with no readily available interpreter.
Any of the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, progresive neurological diseases other than dementia, blindness.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomisation will be performed on a computer with the randomisation facilities within the scientific programming package MATLAB by someone external to the project team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 'datasample' function on MATLAB will be used to randomly allocate enrolled participants to the intervention or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis with 5% significance levels was undertaken using data from previous work and similar studies to determine a total of 80 participants (40 per group) will provide 80% power to detect a significant 30% change in the primary outcome measure.

MATLAB and SPSS will be used for all data analysis. All data collected will be tested for normality using the single sample Kolmogorov-Smirnov goodness of fit hypothesis test. Categorical variables will be tested with a one sample t-test with a null hypothesis of 'mean is zero'. Paired sample t-tests will be used to test before and after differences in paired observations. The Wilcoxon rank sum test for equal medians will be used for data that are non-normally distributed.

Primary and secondary outcomes will be analysed primarily using before and after changes in the scored questionnaire instruments. These will be correlated against the longitudinal sensor data collected automatically by the technology system. Interactions will be analysed using multivariate analysis methods.

Descriptive data models will be used including basic statistics, clustering methods and principal component analysis (PCA). Regression and predictive models include multiple linear regression, principal component regression or partial least squares regression. We will explore classification models such as support vector machine, linear discriminant analysis and partial least squares-discriminant analysis. Some or all of these methods may be applied to the data depending on the level of significance of outcomes achieved.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15528 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 28895 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 304559 0
University
Name [1] 304559 0
University of New South Wales
Country [1] 304559 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW, Sydney, New South Wales, 2052
Country
Australia
Secondary sponsor category [1] 304860 0
None
Name [1] 304860 0
Address [1] 304860 0
Country [1] 304860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304986 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304986 0
Ethics committee country [1] 304986 0
Australia
Date submitted for ethics approval [1] 304986 0
25/11/2019
Approval date [1] 304986 0
11/12/2019
Ethics approval number [1] 304986 0
2019/ETH12068

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

Contacts
Principal investigator
Name 98866 0
Prof Branko Celler
Address 98866 0
Biomedical Systems Research Laboratory
University of NSW
Sydney NSW 2052 AUSTRALIA
Country 98866 0
Australia
Phone 98866 0
+61 2 9385 6546
Fax 98866 0
Email 98866 0
b.celler@unsw.edu.au
Contact person for public queries
Name 98867 0
Branko Celler
Address 98867 0
Biomedical Systems Research Laboratory
University of NSW
Sydney NSW 2052 AUSTRALIA
Country 98867 0
Australia
Phone 98867 0
+61 2 9385 6546
Fax 98867 0
Email 98867 0
b.celler@unsw.edu.au
Contact person for scientific queries
Name 98868 0
Branko Celler
Address 98868 0
Biomedical Systems Research Laboratory
University of NSW
Sydney NSW 2052 AUSTRALIA
Country 98868 0
Australia
Phone 98868 0
+61 2 9385 6546
Fax 98868 0
Email 98868 0
b.celler@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.