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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
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Scientific title
Implementation and evaluation of health care providers' adoption of the StandingTall eHealth fall prevention program into community aged care
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Secondary ID [1]
312544
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mobility problems
334427
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Falls
334793
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Condition category
Condition code
Public Health
331056
331056
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0
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Health service research
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Physical Medicine / Rehabilitation
331354
331354
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329058
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Prevention
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Intervention code [2]
329286
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportion of healthcare professionals who have referred clients
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Assessment method [1]
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Study logs
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Timepoint [1]
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6 months post-implementation
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Secondary outcome [1]
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Total count of clients referred to the program
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Assessment method [1]
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Mixed methods (organisation data, study logs and semi-structured interviews/focus groups -whichever the organisation prefers- to gain insight into referrals)
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Timepoint [1]
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6 months post-implementation
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Secondary outcome [2]
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Proportion of eligible clients who were referred
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Assessment method [2]
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Mixed methods (organization data, study logs and semi-structured interviews/focus groups-whichever the organisation prefers- to gain insight into referrals)
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Timepoint [2]
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6 months post start of implementation
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Secondary outcome [3]
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Composite insight into client and staff engagement, considering participation levels and client characteristics
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Assessment method [3]
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Semi-structured interviews/focus groups-whichever the organisation prefers, qualitative analysis guided by RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)
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Timepoint [3]
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6 months post start of implementation
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Secondary outcome [4]
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Self-reported perceptions of changes in clients' mobility
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Assessment method [4]
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Questionnaire (based on global rating of change scales and phrased specifically for this study) and interviews/focus groups-whichever the organisation prefers
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Timepoint [4]
437609
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6 months post start implementation
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Secondary outcome [5]
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Perceived effectiveness of the program by participants and staff
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Assessment method [5]
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Semi-structured interviews/focus groups-whichever the organisation prefers, thematic analysis using CFIR 2.0, guided by RE-AIM
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Timepoint [5]
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6 months post start implementation
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Secondary outcome [6]
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Count of healthcare professionals who completed training
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Assessment method [6]
438609
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Mixed methods (Organisation data, study logs and semistructured interviews/focus groups-whichever the organisation prefers- to understand training coverage)
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Timepoint [6]
438609
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6 months post start implementation
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Secondary outcome [7]
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Proportion of eligible healthcare professionals who were trained
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Assessment method [7]
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Mixed methods (organisation data, study logs and semi-structured interviews/focus groups-whichever the organisation prefers- to understand training coverage)
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Timepoint [7]
438610
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6 months post start implementation
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Secondary outcome [8]
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Proportion of healthcare professionals who referred three or more clients
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Assessment method [8]
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Mixed methods (organisation data, study logs, and semi-structured interviews/focus groups-whichever the organisation prefers)
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Timepoint [8]
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6 months post-implementation
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Secondary outcome [9]
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Proportion of referred clients who enrolled in the program
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Assessment method [9]
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Mixed methods (organisation data, study logs and semi-structured interviews/focus groups-whichever the organisation prefers- to understand referral success)
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Timepoint [9]
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8 months post-implementation to allow for a delay in enrollment
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Secondary outcome [10]
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Composite insight into reasons for participation and non-participation at organisational and individual levels
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Assessment method [10]
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Semi-structured interviews/focus groups-whichever the organisation prefers- and surveys (acceptability via AIM, appropriateness via IAM, feasibility via FIM), qualitative analysis guided by CFIR 2.0 & RE-AIM
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Timepoint [10]
438626
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6 months post-implementation
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Secondary outcome [11]
438631
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Automatically recorded weekly exercise duration
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Assessment method [11]
438631
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Direct program use data
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Timepoint [11]
438631
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A minimum of 2 and a maximum of 6 months post client enrollment
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Secondary outcome [12]
438632
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Composite insight into time commitment and efficiency gains attributable to the intervention
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Assessment method [12]
438632
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Mixed methods (organisation data, study logs and semi-structured interviews/focus groups-whichever the organisation prefers)
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Timepoint [12]
438632
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6 months post-implementation
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Secondary outcome [13]
438633
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Economic impact evaluation of the intervention
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Assessment method [13]
438633
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Organisation data, study logs to determine staff time commitment for a budget impact analysis
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Timepoint [13]
438633
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6 months post-implementation
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Secondary outcome [14]
438634
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Recorded adverse events count
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Assessment method [14]
438634
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Organisation data, study logs using NHMRC definitions
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Timepoint [14]
438634
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6 months post-implementation
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Secondary outcome [15]
438635
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Reported instances of serious adverse reactions
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Assessment method [15]
438635
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Organisation data, study logs using Common Terminology Criteria
for Adverse Events (CTCAE)
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Timepoint [15]
438635
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6 months post-implementation
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Secondary outcome [16]
438636
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Composite insight into long-term use sustainability and attrition
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Assessment method [16]
438636
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Semi-structured interviews/focus groups-whichever the organisation prefers- guided by CFIR 2.0 & RE-AIM
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Timepoint [16]
438636
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6 months post-implementation
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Secondary outcome [17]
438637
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Proportion of clients with at least 22 hours of program use
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Assessment method [17]
438637
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Direct program use data
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Timepoint [17]
438637
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A minimum of 2 and a maximum of 6 months post client enrollment
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/05/2024
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Date of last participant enrolment
Anticipated
16/05/2025
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Actual
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Date of last data collection
Anticipated
16/07/2025
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Actual
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Sample size
Target
40
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Funding & Sponsors
Funding source category [1]
316969
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Charities/Societies/Foundations
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Name [1]
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HCF research foundation
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Address [1]
316969
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Country [1]
316969
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Australia
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Primary sponsor type
University
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Name
Neuroscience Research Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
319215
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None
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Name [1]
319215
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Address [1]
319215
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Country [1]
319215
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315721
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
315721
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
315721
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Australia
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Date submitted for ethics approval [1]
315721
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10/01/2024
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Approval date [1]
315721
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05/02/2024
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Ethics approval number [1]
315721
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Summary
Brief summary
The research aims to develop and evaluate a delivery model for implementing StandingTall within community aged care services. The delivery model has been designed and will be refined in co-design with aged care providers. The primary outcome will assess adoption (health care professionals are referring clients to the intervention) to the program. Secondary outcome measures include reach, effectiveness, adoption (uptake), implementation, and maintenance.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kim van Schooten
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Address
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Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9399 1087
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Fax
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Email
135606
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k.vanschooten@neura.edu.au
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Contact person for public queries
Name
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Prof Kim Delbaere
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Address
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Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
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Country
135607
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Australia
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Phone
135607
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+61 2 9399 1066
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Fax
135607
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Email
135607
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k.delbaere@neura.edu.au
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Contact person for scientific queries
Name
135608
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Dr Kim van Schooten
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Address
135608
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Neuroscience Research Australia, 139 Barker St, Randwick NSW 2031
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Country
135608
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Australia
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Phone
135608
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+61 2 9399 1087
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Fax
135608
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Email
135608
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k.vanschooten@neura.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
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When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication
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Available to whom?
Researchers who provide a methodologically sound proposal
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Available for what types of analyses?
Researchers who provide a methodologically sound proposal
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (k.vanschooten@neura.edu.au)
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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.
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