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Trial registered on ANZCTR


Registration number
ACTRN12619001329156
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the StandingTall implementation project - technology-driven, home-based balance exercise program to prevent falls
Scientific title
Implementation of StandingTall: Determining eHealth fall prevention uptake and adherence in older people living in the community
Secondary ID [1] 298532 0
Nil
Universal Trial Number (UTN)
U1111-1235-5139
Trial acronym
StandingTall-ER
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
impaired balance 313344 0
accidental falls 314268 0
Condition category
Condition code
Injuries and Accidents 311788 311788 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All intervention participants will receive the StandingTall exercise program for 6 months. StandingTall comprises standing balance (e.g. standing on the floor and/or 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 delivered using tablets/computers. Exercises are delivered through animated instructions on the screen. The StandingTall program is fully optimised to deliver unsupervised, individually-tailored and progressive balance exercises using mobile technology (computer/tablet and internet). Online StandingTall safety training is provided for participants, support persons and exercise specialists through the StandingTall website. The training module includes a quiz, an 80% pass mark is needed for participants and exercise specialists to receive access to the StandingTall program and control management system respectively. Participants are expected to have an installation session with an exercise specialist (e.g. physiotherapist, exercise physiologist, sports scientist, fitness leader with prior experience in delivering exercise to older people) before starting the program. The StandingTall program automatically progresses exercise dose, in the first 2 weeks the dose is 40 minutes per week, and increases by 20 minutes fortnightly, to finally reach a dose of 2 hr/wk from week 9 onwards. Exercise intensity is individually tailored using a modified perceived exertion 5-point Likert scale (1 = unstable and 5 = very stable). Exercise intensity rating ensures the exercises are of moderate to high challenge and increase in difficulty according to the user’s ability. Within the StandingTall program, participants rate exercise intensity after each exercise, which determines whether the exercise progresses, remains stable or regresses. Participants have full autonomy to choose the timing and duration of their sessions. Adherence data is automatically transferred to a secure server at Neuroscience Research Australia. Weekly exercise minutes (adherence) can be monitored in the control management system.
Intervention code [1] 314834 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320521 0
Adherence to the StandingTall program as weekly training dose and total training dose recorded by the program and monitored following data transfer to server
Timepoint [1] 320521 0
6 months after baseline assessment
Secondary outcome [1] 373858 0
Acceptability of the StandingTall program to older people using an evaluation survey designed for this study which includes question/s on usability of the program
Timepoint [1] 373858 0
3 and 6 months after baseline assessment
Secondary outcome [2] 373859 0
Acceptability of the StandingTall program to health professionals and exercise instructors using an evaluation survey designed for this study which includes question/s on the impact of the program on professional practice
Timepoint [2] 373859 0
12 months after starting the study
Secondary outcome [3] 373860 0
Adoption: Uptake and referral by health care and community services documented in an engagement log recorded by research staff throughout the study period
Timepoint [3] 373860 0
12 months after starting the study
Secondary outcome [4] 373861 0
Appropriateness of the training modules and other resources on the accompanying StandingTall website to older people using an online website survey developed for this study
Timepoint [4] 373861 0
On visiting the website and on completion of the website training module
Secondary outcome [5] 373862 0
Appropriateness of the training modules and other resources on the accompanying StandingTall website to health professionals, exercise instructors and support persons using an online website survey developed for this study
Timepoint [5] 373862 0
On visiting the website and on completion of the website training module
Secondary outcome [6] 373863 0
Appropriateness of the StandingTall program to older persons using the app using an evaluation survey developed for this study with questions related to user experience
Timepoint [6] 373863 0
3 and 6 months after baseline assessment
Secondary outcome [7] 373864 0
Feasibility of monitoring adherence by the exercise trainers recorded on monitoring logs by research staff
Timepoint [7] 373864 0
12 months after starting the study
Secondary outcome [8] 373866 0
Implementation cost of each intervention component from a health sector perspective captured from trial financial records
Timepoint [8] 373866 0
12 months after starting the study
Secondary outcome [9] 373869 0
Sustainability as the extent to which StandingTall is maintained within the services will be evaluated using surveys question/s designed for this study
Timepoint [9] 373869 0
12 months after starting the trial

Eligibility
Key inclusion criteria
The trial will involve consenting adults who are:
• male or female;
• 60+ years;
• living in the community (as opposed to residential care);
• have no major mobility limitation (ability to walk 10m indoors without the use of assistive device);
• without major cognitive impairment (no diagnosis of dementia or cognitive impairment)
• have sufficient English language skills to comprehend an internet-based intervention.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The trial will exclude adults who are:
• residents of residential aged care facilities;
• have the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, progressive neurological diseases;
• unstable medical condition that precludes exercise participation
• considered not suitable for study participation by their family doctor or health care worker;
• have a major cognitive impairment (a diagnosis of dementia or cognitive impairment);
• have mobility limitations (Unable to walk unaided around the home)
• visual impairment that cannot be corrected with glasses

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation
The primary analysis will estimate mean adherence, measured as minutes of exercise per week. With a SD of 43.1 minutes (estimated from an earlier trial), a sample size of 83 participants would yield estimates of the mean with a Confidence Interval width less than or equal to +/- 10 minutes in 80% of studies. To allow for an approximately 20% loss to follow-up we will test 100 participants per site.

Statistical Analysis
* Quantitative data analysis. Adherence will be recorded by the StandingTall app and the data automatically transferred to our secure server, total exercise minutes and mean (95% CI) weekly exercise minutes will be calculated from this data. We will also examine the predictors of acceptability and adherence using multivariate modelling techniques. Number and proportions of responses to survey questions will also be reported.
*Qualitative data analysis. Interviews will be audio-recorded, transcribed verbatim and entered into QSR NVivo. Thematic analysis will identify patterns within and across study sites. A combination of inductive and deductive coding will be used – commencing with examination of barriers and facilitators, but open to unexpected findings that may contribute to these or other themes.
* Quantitative preferences. A discrete choice experiment (DCE), administered through a survey, will examine the user’s preferences for, and acceptable trade-offs between, aspects of StandingTall, including costs and other factors identified by qualitative interviews.
* A cost-benefit evaluation will estimate implementation and per-person costs, overall benefit of StandingTall and potential number of users. This will result in a business case development for widespread implementation of StandingTall.

Recruitment
Recruitment status
Not yet 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,VIC
Recruitment hospital [1] 14076 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 14077 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 27569 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 27570 0
2480 - Lismore
Recruitment postcode(s) [3] 26867 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 26866 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 21880 0
United Kingdom
State/province [1] 21880 0
Northern England

Funding & Sponsors
Funding source category [1] 303060 0
Government body
Name [1] 303060 0
National Health and Medical Research Council
Address [1] 303060 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 303060 0
Australia
Funding source category [2] 303876 0
Government body
Name [2] 303876 0
NSW Ministry of Health
Address [2] 303876 0
73 Miller Street
North Sydney NSW Australia
Country [2] 303876 0
Australia
Funding source category [3] 303877 0
Government body
Name [3] 303877 0
Northern Health Science Alliance Ltd.
Address [3] 303877 0
Weightmans LLP
Hardman Square
No 1 Spinningfields
Manchester M3 3EB
Country [3] 303877 0
United Kingdom
Funding source category [4] 303889 0
Government body
Name [4] 303889 0
National Institute for Health Research
Address [4] 303889 0
Grange House
15 Church street
Twickenham
TW1 3NL
Country [4] 303889 0
United Kingdom
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 303063 0
Other
Name [1] 303063 0
The University of Manchester
Address [1] 303063 0
School of Health Sciences
Oxford Road
Manchester M13 9PL
Country [1] 303063 0
United Kingdom
Other collaborator category [1] 280963 0
Hospital
Name [1] 280963 0
Austin Health
Address [1] 280963 0
Level 8, Harold Stokes Building, Austin Health
145 Studley Rd
Heidelberg VIC 3084
Country [1] 280963 0
Australia
Other collaborator category [2] 280964 0
Government body
Name [2] 280964 0
Mid North Coast Local Health District
Address [2] 280964 0
19-31 Morton Street
Port Macquarie NSW 2444
Country [2] 280964 0
Australia
Other collaborator category [3] 280965 0
Government body
Name [3] 280965 0
Northern NSW Local Health District
Address [3] 280965 0
31 Uralba Street
Lismore NSW 2480
Country [3] 280965 0
Australia
Other collaborator category [4] 280966 0
Individual
Name [4] 280966 0
Professor Chris Todd
Address [4] 280966 0
Contact person for public queries in the United Kingdom

The University of Manchester
School of Health Sciences
Oxford Road
Manchester M13 9PL


Tel: (+44) (0)161-306-7865
Fax: (+44) (0)161-306-7894

Email: chris.todd@manchester.ac.uk
Country [4] 280966 0
United Kingdom
Other collaborator category [5] 280967 0
Individual
Name [5] 280967 0
Dr Helen Hawley-Hague
Address [5] 280967 0
Contact person for scientific queries in the United Kingdom

The University of Manchester
School of Health Sciences
Oxford Road
Manchester M13 9PL

Email: Helen.hawley-hague@manchester.ac.uk
Country [5] 280967 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303610 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 303610 0
Research Support Office
Prince of Wales Hospital
G71 East Wing , Edmund Blacket Building
Prince of Wales Hospital, RANDWICK NSW 2031
Ethics committee country [1] 303610 0
Australia
Date submitted for ethics approval [1] 303610 0
28/11/2018
Approval date [1] 303610 0
28/02/2019
Ethics approval number [1] 303610 0
HREC 18/288
Ethics committee name [2] 304384 0
Research Ethics Service
Ethics committee address [2] 304384 0
Health Research Authority
Skipton House
80 London Road
London SE1 6LH
Ethics committee country [2] 304384 0
United Kingdom
Date submitted for ethics approval [2] 304384 0
07/10/2019
Approval date [2] 304384 0
Ethics approval number [2] 304384 0

Summary
Brief summary
StandingTall targets a major need for older people for whom falls are a real risk that can have debilitating impacts on quality of life. This project aims to evaluate the implementation of StandingTall in clinical practice and the community in multiple sites across Australia and Northern England. We will monitor exercise adherence, as well as acceptability and uptake of StandingTall in older people and health care workers. Our primary aim is to estimate mean adherence at each site with a confidence interval width of +/- 10 minutes. This project addresses the final steps needed to disseminate this innovative technology for widespread use by older people across Australia, UK and internationally.
Trial website
www.standingtall.org.au
Trial related presentations / publications
Public notes
This is an international trial with sites in Australia and the United Kingdom. The Australian sites will start first, followed by the Northern England sites at a later date.

Contacts
Principal investigator
Name 94250 0
A/Prof Kim Delbaere
Address 94250 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country 94250 0
Australia
Phone 94250 0
+612 9399 1066
Fax 94250 0
+612 9399 1204
Email 94250 0
k.delbaere@neura.edu.au
Contact person for public queries
Name 94251 0
A/Prof Kim Delbaere
Address 94251 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country 94251 0
Australia
Phone 94251 0
+612 9399 1066
Fax 94251 0
+612 9399 1204
Email 94251 0
k.delbaere@neura.edu.au
Contact person for scientific queries
Name 94252 0
Dr Morag Taylor
Address 94252 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country 94252 0
Australia
Phone 94252 0
+612 9399 1885
Fax 94252 0
+612 9399 1204
Email 94252 0
m.taylor@neura.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
No ethical approval to share individual participant data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results