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Trial registered on ANZCTR


Registration number
ACTRN12619000540112
Ethics application status
Approved
Date submitted
14/03/2019
Date registered
4/04/2019
Date last updated
31/07/2019
Date data sharing statement initially provided
4/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
StandingTall-Plus: A 1-year randomised controlled trial of a novel multifactorial intervention for preventing falls in older people
Scientific title
A novel multifactorial intervention for preventing falls in older people over 1 year: randomised controlled trial
Secondary ID [1] 297167 0
None
Universal Trial Number (UTN)
U1111-1227-1999
Trial acronym
StandingTall-Plus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 311202 0
Condition category
Condition code
Injuries and Accidents 309820 309820 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises 1 year (52 weeks) of tailored balance exercise, cognitive behavioural therapy and cognitive motor training (CMT). The intervention group will receive up to 3 programs, as described below.
1. All intervention participants will receive the StandingTall-Balance exercise program on a tablet computer from week 1 up to and including week 52. The home-based exercise training offers an effective way for people to improve their balance, reduce their fall risk and increase their physical activity with greater confidence. It comprises standing balance (e.g. standing on a foam surface), 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 box (e.g. step up and over a box) exercises. The program is fully optimised to deliver unsupervised and individually-tailored balance exercises that increase in difficulty over time through mobile technology (tablet and internet). Participants will be instructed to complete 40 min/wk in the first 2 weeks, and increase the exercise dose by 20 min fortnightly, to finally reach a dose of 2 or 3 hr/wk based on their fall risk score on the Physiological Profile Assessment (2 hours if PPA < 0.6; 3 hours if PPA >= 0.6 unless concurrent StandingTall-CMT is prescribed). Participants have full autonomy to choose the timing and duration of their sessions.
2. Intervention participants with depressive symptoms (GDS-15 >= 5) will receive a fully-automated cognitive behavioural therapy program (myCompass) delivered through a tablet or computer in people’s homes with no therapist input from week 1 up to and including week 7. The myCompass program offers evidence-based and interactive psychological modules that users can complete via the internet on a tablet or computer in their homes. Each module comprises three 10-minute sessions and includes activities for users to complete on the computer. There are home practice tasks recommended for participants to complete between the online sessions (i.e. completion of one full module per week followed by 1 week of practice), which are intended to promote skill generalisation. Participants will be instructed to complete 1 module per week and self-monitor daily (30 min/wk), with the aim of completing 3 full modules during the first 7 weeks of the trial.
3. Intervention participants with poor executive functioning (TMT B-A >=50s) will receive the StandingTall-Cognitive Motor Training program to improve executive function and attention on a tablet computer from week 5 up to and including week 52. Concomitant cognitive tasks, relying primarily on executive function, are added to StandingTall balance exercises by using auditory and visual cues. Three core executive functions are engaged: inhibition (the ability to consciously override automated or dominant responses), working memory (the ability to hold, process, and manipulate information in mind) and task shifting (the ability to switch flexibly between tasks or mental sets). Participants will receive 50% (if on a 2 hr StandingTall dose) or 33% (if on a 3 hr StandingTall dose) of their weekly StandingTall-Balance exercise dose, with a final dose of 1 hr/wk, as StandingTall-Cognitive Motor Training.
All programs are delivered in a similar way through a tablet computer and use of personalised encouragement messages and compliance-promoting features.

* Tailoring of total exercise recommendation will be guided by the Multifactorial Profile Assessment (PPA, GDS, TMT) and will remain tailored to the participant’s abilities through the intervention over the duration of the trial (1 year).

* Following the baseline assessment at Neuroscience Research Australia, an exercise physiologist from the research team will explain to the participant how to use the StandingTall and myCompass programs during a home visit with an approximate duration of 2 hr.

* All participants will receive a phone call around week 4 to remind people of the health promotion education program and, when relevant, follow up on adherence and inform intervention participants with poor executive functioning that the StandingTall-Cognitive Motor Training program will become available as of week 5.

* Participants will be given their own login and password to access the StandingTall and myCompass programs on a tablet computer. Tablets will be provided for participants without home computers or internet access.

* Participant adherence (training duration and frequency) will be monitored following automatic data transfer to a server and examined weekly. Participants not engaging in the minimum weekly training duration for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence for the first 6 months.

* Phone, email support and home visits will be available as needed for the entire duration of the study.
Intervention code [1] 313428 0
Prevention
Comparator / control treatment
Both groups will receive a health promotion education program with a focus on general health concerns relevant to older adults (e.g. blood pressure, healthy diet, medications). The control group will only receive the health promotion education program. The program will be provided to the participants through a website with weekly updates. The program has no therapeutic content and has been successfully used as a placebo in previous studies by members of the research team. Adherence will be tracked automatically through the website.
Control group
Placebo

Outcomes
Primary outcome [1] 319140 0
The rate of falling in each group: Falls will be monitored with monthly fall diaries.
Timepoint [1] 319140 0
At 12 months after randomisation
Secondary outcome [1] 367073 0
The rate of falling in each group: Falls will be monitored with monthly fall diaries.
Timepoint [1] 367073 0
At 6 months after randomisation
Secondary outcome [2] 368431 0
Proportion of fallers defined as participants who experienced >=1 fall/yr. Falls will be monitored with monthly fall diaries.
Timepoint [2] 368431 0
At 6 and 12 months after randomisation
Secondary outcome [3] 368432 0
Proportion of multiple fallers defined as participants who experienced >=2 fall/yr. Falls will be monitored with monthly fall diaries.
Timepoint [3] 368432 0
At 6 and 12 months after randomisation
Secondary outcome [4] 368433 0
Questionnaire measure of physical activity levels using the Incidental and Planned Exercise Questionnaire.
Timepoint [4] 368433 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [5] 368434 0
Physical activity levels and mobility monitoring during daily activities over 1 week using a wearable sensor (MoveMonitor, McRoberts, the Netherlands).
Timepoint [5] 368434 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [6] 368435 0
Composite fall risk score using the Physiological Profile Assessment (containing individual tests of knee extension strength, postural sway, lower limb proprioception, hand simple reaction time, and Melbourne- edge test of edge contrast sensitivity)
Timepoint [6] 368435 0
At baseline and at 6 months after randomisation
Secondary outcome [7] 368436 0
Clinical measure of balance: Standing balance using the Romberg test battery
Timepoint [7] 368436 0
At baseline and at 6 months after randomisation
Secondary outcome [8] 368437 0
Update Clinical measure of balance: Maximum anteroposterior balance range
Timepoint [8] 368437 0
At baseline and at 6 months after randomisation
Secondary outcome [9] 368438 0
Clinical measure of balance: coordinated stability test
Timepoint [9] 368438 0
At baseline and at 6 months after randomisation
Secondary outcome [10] 368439 0
Composite clinical measure of mobility using the Short Physical Performance Battery (SPPB; containing standing, transferring, and walking)
Timepoint [10] 368439 0
At baseline and at 6 months after randomisation
Secondary outcome [11] 368440 0
Clinical measure of mobility - transferring, walking, turning: timed up-and-go (TUG)
Timepoint [11] 368440 0
At baseline and at 6 months after randomisation
Secondary outcome [12] 368441 0
Clinical measure of mobility - transferring, walking, turning: 5 time sit-to-stand test (5-STS)
Timepoint [12] 368441 0
At baseline and at 6 months after randomisation
Secondary outcome [13] 368442 0
Clinical measure of mobility - transferring, walking, turning: timed 10-meter walk test (10MW)
Timepoint [13] 368442 0
At baseline and at 6 months after randomisation
Secondary outcome [14] 368443 0
Clinical measure of mobility - transferring, walking, turning: timed 10-meter walking test with cognitive dual task (10MDTW)
Timepoint [14] 368443 0
At baseline and at 6 months after randomisation
Secondary outcome [15] 368444 0
Measure of reaction time: colour choice reaction time test
Timepoint [15] 368444 0
At baseline and at 6 months after randomisation
Secondary outcome [16] 368445 0
Measure of reaction time: 'catch-the-ruler' ReacStick test
Timepoint [16] 368445 0
At baseline and at 6 months after randomisation
Secondary outcome [17] 368446 0
Measure of reaction time: choice stepping reaction time test
Timepoint [17] 368446 0
At baseline and at 6 months after randomisation
Secondary outcome [18] 368447 0
Measure of reaction time: inhibitory choice stepping reaction time test
Timepoint [18] 368447 0
At baseline and at 6 months after randomisation
Secondary outcome [19] 368448 0
Composite measure of executive functioning using two Cogstate computerized cognitive tests (i.e. Groton maze learning test, one-back test)
Timepoint [19] 368448 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [20] 368449 0
Measure of executive functioning: Cogstate Groton maze learning test
Timepoint [20] 368449 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [21] 368450 0
Measure of executive functioning: Cogstate one-back test
Timepoint [21] 368450 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [22] 368451 0
Measure of executive functioning and processing speed: Stroop choice stepping Reaction time test
Timepoint [22] 368451 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [23] 368452 0
Measure of executive functioning: Trail making tests (Part A, Part B, Part B minus A)
Timepoint [23] 368452 0
At baseline and at 6 months after randomisation
Secondary outcome [24] 368453 0
Questionnaire measure of concern about falling using the iconographical Falls Efficacy Scale
Timepoint [24] 368453 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [25] 368454 0
Questionnaire measures of depression, anxiety and stress: Depression, Anxiety and Stress Scales (DASS)
Timepoint [25] 368454 0
At baseline, at 7 weeks, at 6 and 12 months after randomisation
Secondary outcome [26] 368455 0
Questionnaire measure of depression: Geriatric Depression Scale (GDS-30)
Timepoint [26] 368455 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [27] 368456 0
Questionnaire measure of well-being: COMPAS-W
Timepoint [27] 368456 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [28] 368457 0
Questionnaire measure of health-related quality of life: European QoL-5 Dimensions (EQ-5D-5L)
Timepoint [28] 368457 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [29] 368458 0
Questionnaire measure of health-related quality of life: WHO Disability Assessment Schedule (WHODAS)
Timepoint [29] 368458 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [30] 368459 0
Questionnaire measure of health-related quality of life: ICEpop CAPability (ICECAP-O)
Timepoint [30] 368459 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [31] 368460 0
Questionnaire measures of health literacy: Health Literacy Questionnaire (HLQ)
Timepoint [31] 368460 0
At baseline and at 6 and 12 months after randomisation
Secondary outcome [32] 368462 0
Health care use recorded with monthly diaries and data linkage via CHeReL
Timepoint [32] 368462 0
At 6 and 12 months after randomisation
Secondary outcome [33] 368463 0
Adherence to the intervention as weekly training dose and total training dose recorded by the tablet computer and monitored following data transfer to server
Timepoint [33] 368463 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [34] 368464 0
Questionnaire measures related to the StandingTall-Plus exercise programs: Usability of the intervention is assessed using the System Usability Scale
Timepoint [34] 368464 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [35] 368465 0
Questionnaire measures related to the StandingTall-Plus exercise programs: Enjoyment of the intervention is assessed using the Physical Activity Enjoyment Scale
Timepoint [35] 368465 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [36] 368466 0
Questionnaire measures related to the StandingTall-Plus exercise programs: Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale
Timepoint [36] 368466 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [37] 368467 0
Questionnaire measures related to the StandingTall-Plus exercise programs: Exercise self-efficacy is assessed using the Exercise Self-Efficacy Scale
Timepoint [37] 368467 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [38] 368468 0
Adverse events due to system use (e.g. falls) monitored by self-report through monthly diaries and phone calls
Timepoint [38] 368468 0
At 6 and 12 months after randomisation (intervention group only)
Secondary outcome [39] 368469 0
Self-reported change in balance, physical activity and overall quality of life using the Patient’s Global Impression of Change (PGIC) Scale
Timepoint [39] 368469 0
At 6 and 12 months after randomisation

Eligibility
Key inclusion criteria
Healthy volunteers at high-risk of falls based on the following criteria: experienced 1+ falls in the past 6 months AND/OR have a self-reported fear of falling AND/OR are 80+ years.

* 65 years of age or older
* Living in the community
* Proficient in English
* Independent in activities of daily living
* Able to walk household distances without the use of a walking aid
* Willingness to give informed consent and comply with the study protocol
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unstable or acute medical condition that precludes exercise participation
* Progressive neurological condition (such as Parkinson’s disease, Multiple Sclerosis)
* Cognitively impaired defined as a Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score <8
* Severe depression or suicidal thoughts (Patient Health Questionnaire-9 score >=20 or scoring 3 on the last question) or acute psychiatric condition with psychosis
* Currently participating in a fall prevention program

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 to the intervention or control group will be performed using an independent web-based randomisation service run at NeuRA. Assessments will be conducted by assessors who will be blinded to group allocation. Due to the nature of the trial, the participants will not be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with separate randomisations for singles and couples to reduce the risk of contamination within the same household.
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
Analyses will be conducted using SPSS and Stata software packages. All analyses will follow a detailed statistical analysis plan made publicly available prior to analysis of the data. Analyses will be conducted while masked to group allocation and will use an intention-to-treat approach.
* Number of falls per person-year will be compared between groups using negative binomial or Poisson regression (depending on the data distribution). Secondary analyses using causal modelling will be conducted to establish intervention effects in people with greater adherence.
* Proportion of fallers between groups will be compared using logistic or robust Poisson regression (depending on the data distribution). Generalised linear models will be used to assess the effect of group allocation on continuously scored secondary outcome measures. Ordinal outcomes will be analysed for between-group differences using ordinal regression or logistic regression (depending on the data distribution).
* Economic analysis will be conducted from a health & community care provider perspective and comprise a cost-effectiveness analysis and a cost-utility analysis. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios. A cost-effectiveness acceptability curve will be plotted to provide information about the probability that the intervention is cost-effective at different willingness to pay thresholds.

A sample size calculation (p<0.05, power=0.8, 20% dropout rate) indicated a total sample size of 518 will be necessary to see an effect on fall rate using a negative binomial regression. The overdispersion parameter alpha was set to 1.2 based on a previous fall prevention trial (Haran et al., 2010). The control group fall rate was assumed 1.09 fall per person-year (Delbaere, Close, Heim, et al., 2010). An incidence Rate Ratio of 0.67 was chosen as the smallest worthwhile effect that justifies associated costs, risks and inconveniences (Franco et al., 2016), which was also supported by meta-regression results for exercise (Sherrington et al., 2017) and multifactorial interventions (Gillespie et al., 2012).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302019 0
Government body
Name [1] 302019 0
National Health and Medical Research Council
Address [1] 302019 0
GHD Building Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Country [1] 302019 0
Australia
Primary sponsor type
University
Name
Neuroscience Research Australia; University of New South Wales
Address
139 Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 301806 0
University
Name [1] 301806 0
Black Dog Institute; University of New South Wales
Address [1] 301806 0
Hospital Rd
Prince of Wales Hospital
Randwick NSW 2031
Country [1] 301806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302707 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 302707 0
UNSW Sydney
NSW 2052
Ethics committee country [1] 302707 0
Australia
Date submitted for ethics approval [1] 302707 0
14/11/2017
Approval date [1] 302707 0
15/12/2017
Ethics approval number [1] 302707 0
HC17977

Summary
Brief summary
Falls in older people are often caused by a concomitant decline across three domains: mobility, cognition and affect; or in other words, across moving – thinking – feeling domains. The aim of this trial is to test a program that is individually tailored to physical, cognitive and affective aspects (as opposed to medical pathologies) by taking a multifactorial profile approach to fall prevention. The use of technology will ensure that is easily accessible to do in the home and engaging to continue over a long period.

A randomised controlled trial will be conducted in 518 community-dwelling older adults at high-risk of falls. All participants will be assessed using a comprehensive test battery of known falls risk factors across physical, cognitive and affective domains. This will then be used to offer each participant a fully tailored program that is suited to their abilities and circumstances. Our primary aim is to reduce the number of falls over a 12-month follow-up period when compared to a health promotion program.

We hypothesise that our program will improve balance, cognitive function and mood, increase physical activity levels and reduce falls in older people, when compared to a health promotion program. This trial addresses a key gap in the understanding of falls interventions and application of personalized medicine and will provide direct evidence about the cost and effectiveness of a tailored multifaceted “best-bet” solution.
Trial website
https://www.neura.edu.au/project/standingtall-plus-a-multifactorial-program-to-prevent-falls-in-older-people/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53870 0
A/Prof Kim Delbaere
Address 53870 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 53870 0
Australia
Phone 53870 0
+61 2 9399 1066
Fax 53870 0
Email 53870 0
k.delbaere@neura.edu.au
Contact person for public queries
Name 53871 0
A/Prof Kim Delbaere
Address 53871 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 53871 0
Australia
Phone 53871 0
+61 2 9399 1066
Fax 53871 0
Email 53871 0
k.delbaere@neura.edu.au
Contact person for scientific queries
Name 53872 0
A/Prof Kim Delbaere
Address 53872 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country 53872 0
Australia
Phone 53872 0
+61 2 9399 1066
Fax 53872 0
Email 53872 0
k.delbaere@neura.edu.au

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)?
Following the publication of the main results and ending 15 years following the publication of the main results
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis
Available for what types of analyses?
On a case-by-case basis
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results