Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001121550
Ethics application status
Approved
Date submitted
16/07/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of an eHealth fall prevention program into community aged care
Scientific title
Implementation and evaluation of health care providers' adoption of the StandingTall eHealth fall prevention program into community aged care
Secondary ID [1] 312544 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility problems 334427 0
Falls 334793 0
Condition category
Condition code
Public Health 331056 331056 0 0
Health service research
Physical Medicine / Rehabilitation 331354 331354 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
StandingTall is a technology-driven exercise program for older people that has proven effective in preventing falls and improving balance (Delbaere et al 2021 BMJ). The program is provided via a tablet or desktop computer and can be used independently at home. StandingTall incorporates (i) evidence-based, individually tailored and progressive balance exercise and cognitive-motor training to improve balance ability and reduce fall risk in older people and (ii) behavioural change techniques to enhance exercise uptake and long-term adherence. The exercises comprise standing balance, transferring (e.g. sit-stand transitions), walking (e.g. walking in circles or to targets in a grid), stepping (e.g. step and lift) and obstacle negotiation (e.g. stepping up and over a box) exercises. Concomitant cognitive tasks, relying primarily on executive function (i.e. inhibition, working memory, task-shifting), are added to the balance exercises to train the brain using auditory and visual cues. The program starts with a detailed inbuilt assessment to identify the optimal set of exercises from the StandingTall exercise library of over 6000 exercise variations for each user. Exercises are performed by following an onscreen avatar. Exercise intensity is monitored using a self-reported rating of perceived exertion and progresses as performance changes over time. The program incorporates a paced approach and goal setting to increase exercise dose and is suitable for long-term independent use at home for 2 hours or more per week.

Together with aged care providers, we have co-designed and continue to refine a delivery model, which relies on training resident experts and healthcare professional referrals, for providing StandingTall to older people receiving community aged care, where healthcare professionals will provide clients with access to the program and support continued usage. This study will evaluate the implementation of this delivery model over six months. Healthcare professionals will be offered online or in-person training (1 hr for referring healthcare professionals and 4 hrs for resident experts) and ongoing support as required to provide StandingTall to their clients. Outcomes will focus on the adoption of the program by healthcare professionals. Secondary outcome measures include reach, effectiveness, adoption (uptake), implementation, and maintenance.
Intervention code [1] 329058 0
Prevention
Intervention code [2] 329286 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338827 0
Proportion of healthcare professionals who have referred clients
Timepoint [1] 338827 0
6 months post-implementation
Secondary outcome [1] 437606 0
Total count of clients referred to the program
Timepoint [1] 437606 0
6 months post-implementation
Secondary outcome [2] 437607 0
Proportion of eligible clients who were referred
Timepoint [2] 437607 0
6 months post start of implementation
Secondary outcome [3] 437608 0
Composite insight into client and staff engagement, considering participation levels and client characteristics
Timepoint [3] 437608 0
6 months post start of implementation
Secondary outcome [4] 437609 0
Self-reported perceptions of changes in clients' mobility
Timepoint [4] 437609 0
6 months post start implementation
Secondary outcome [5] 437610 0
Perceived effectiveness of the program by participants and staff
Timepoint [5] 437610 0
6 months post start implementation
Secondary outcome [6] 438609 0
Count of healthcare professionals who completed training
Timepoint [6] 438609 0
6 months post start implementation
Secondary outcome [7] 438610 0
Proportion of eligible healthcare professionals who were trained
Timepoint [7] 438610 0
6 months post start implementation
Secondary outcome [8] 438611 0
Proportion of healthcare professionals who referred three or more clients
Timepoint [8] 438611 0
6 months post-implementation
Secondary outcome [9] 438625 0
Proportion of referred clients who enrolled in the program
Timepoint [9] 438625 0
8 months post-implementation to allow for a delay in enrollment
Secondary outcome [10] 438626 0
Composite insight into reasons for participation and non-participation at organisational and individual levels
Timepoint [10] 438626 0
6 months post-implementation
Secondary outcome [11] 438631 0
Automatically recorded weekly exercise duration
Timepoint [11] 438631 0
A minimum of 2 and a maximum of 6 months post client enrollment
Secondary outcome [12] 438632 0
Composite insight into time commitment and efficiency gains attributable to the intervention
Timepoint [12] 438632 0
6 months post-implementation
Secondary outcome [13] 438633 0
Economic impact evaluation of the intervention
Timepoint [13] 438633 0
6 months post-implementation
Secondary outcome [14] 438634 0
Recorded adverse events count
Timepoint [14] 438634 0
6 months post-implementation
Secondary outcome [15] 438635 0
Reported instances of serious adverse reactions
Timepoint [15] 438635 0
6 months post-implementation
Secondary outcome [16] 438636 0
Composite insight into long-term use sustainability and attrition
Timepoint [16] 438636 0
6 months post-implementation
Secondary outcome [17] 438637 0
Proportion of clients with at least 22 hours of program use
Timepoint [17] 438637 0
A minimum of 2 and a maximum of 6 months post client enrollment

Eligibility
Key inclusion criteria
Inclusion criteria for healthcare professionals invited to take part in this study include:
1. Qualified and working as a healthcare professional.
2. Employed at one of the partner organisations.
3. Willing to recruit clients to use the StandingTall program as part of fall prevention treatment and strategies.

Eligible clients are identified by healthcare professionals as:
1. Aged 60 years and over.
2. Able to walk safely for 10 metres with/without a walking aid.
3. Willing to use the StandingTall program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clients are ineligible if:
1. Clients who are wheelchair bound or have visual impairment that cannot be corrected with glasses will be excluded for safety considerations.
2. Clients with acute medical illnesses, or unstable medical conditions that preclude exercise participation.
3. Clients considered not suitable for study participation by referring healthcare worker.

Study design
Purpose of the study
Educational / counselling / training
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/05/2024
Date of last participant enrolment
Anticipated
16/05/2025
Actual
Date of last data collection
Anticipated
16/07/2025
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 316969 0
Charities/Societies/Foundations
Name [1] 316969 0
HCF research foundation
Country [1] 316969 0
Australia
Primary sponsor type
University
Name
Neuroscience Research Australia
Address
Country
Australia
Secondary sponsor category [1] 319215 0
None
Name [1] 319215 0
Address [1] 319215 0
Country [1] 319215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315721 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 315721 0
Ethics committee country [1] 315721 0
Australia
Date submitted for ethics approval [1] 315721 0
10/01/2024
Approval date [1] 315721 0
05/02/2024
Ethics approval number [1] 315721 0

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

Contacts
Principal investigator
Name 135606 0
Dr Kim van Schooten
Address 135606 0
Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
Country 135606 0
Australia
Phone 135606 0
+61 2 9399 1087
Fax 135606 0
Email 135606 0
[email protected]
Contact person for public queries
Name 135607 0
Prof Kim Delbaere
Address 135607 0
Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
Country 135607 0
Australia
Phone 135607 0
+61 2 9399 1066
Fax 135607 0
Email 135607 0
[email protected]
Contact person for scientific queries
Name 135608 0
Dr Kim van Schooten
Address 135608 0
Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
Country 135608 0
Australia
Phone 135608 0
+61 2 9399 1087
Fax 135608 0
Email 135608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Researchers who provide a methodologically sound proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.