Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619001329156
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
30/09/2019
Date last updated
27/06/2022
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
Query!
Scientific title
Implementation of StandingTall: Determining eHealth fall prevention uptake and adherence in older people living in the community
Query!
Secondary ID [1]
298532
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1235-5139
Query!
Trial acronym
StandingTall-ER
Query!
Linked study record
None
Query!
Health condition
Health condition(s) or problem(s) studied:
impaired balance
313344
0
Query!
accidental falls
314268
0
Query!
Condition category
Condition code
Injuries and Accidents
311788
311788
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
314834
0
Prevention
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
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
Query!
Assessment method [1]
320521
0
Query!
Timepoint [1]
320521
0
6 months after baseline assessment
Query!
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
Query!
Assessment method [1]
373858
0
Query!
Timepoint [1]
373858
0
3 and 6 months after baseline assessment
Query!
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
Query!
Assessment method [2]
373859
0
Query!
Timepoint [2]
373859
0
12 months after starting the study
Query!
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
Query!
Assessment method [3]
373860
0
Query!
Timepoint [3]
373860
0
12 months after starting the study
Query!
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
Query!
Assessment method [4]
373861
0
Query!
Timepoint [4]
373861
0
On visiting the website and on completion of the website training module
Query!
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
Query!
Assessment method [5]
373862
0
Query!
Timepoint [5]
373862
0
On visiting the website and on completion of the website training module
Query!
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
Query!
Assessment method [6]
373863
0
Query!
Timepoint [6]
373863
0
3 and 6 months after baseline assessment
Query!
Secondary outcome [7]
373864
0
Feasibility of monitoring adherence by the exercise trainers recorded on monitoring logs by research staff
Query!
Assessment method [7]
373864
0
Query!
Timepoint [7]
373864
0
12 months after starting the study
Query!
Secondary outcome [8]
373866
0
Implementation cost of each intervention component from a health sector perspective captured from trial financial records
Query!
Assessment method [8]
373866
0
Query!
Timepoint [8]
373866
0
12 months after starting the study
Query!
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
Query!
Assessment method [9]
373869
0
Query!
Timepoint [9]
373869
0
12 months after starting the trial
Query!
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.
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Data collected is being analysed
Query!
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Query!
Other reasons
The trial was severely impacted by natural disasters (bushfires and floods) in Australia at the start, and then by COVID lockdowns in both Australia and the UK.
Query!
Date of first participant enrolment
Anticipated
2/10/2019
Query!
Actual
30/10/2019
Query!
Date of last participant enrolment
Anticipated
30/06/2021
Query!
Actual
12/10/2021
Query!
Date of last data collection
Anticipated
31/12/2021
Query!
Actual
12/04/2022
Query!
Sample size
Target
400
Query!
Accrual to date
Query!
Final
246
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
14076
0
Austin Health - Austin Hospital - Heidelberg
Query!
Recruitment hospital [2]
14077
0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Query!
Recruitment postcode(s) [1]
27569
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [2]
27570
0
2480 - Lismore
Query!
Recruitment postcode(s) [3]
26867
0
3081 - Heidelberg West
Query!
Recruitment postcode(s) [4]
26866
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
21880
0
United Kingdom
Query!
State/province [1]
21880
0
Northern England
Query!
Funding & Sponsors
Funding source category [1]
303060
0
Government body
Query!
Name [1]
303060
0
National Health and Medical Research Council
Query!
Address [1]
303060
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
303060
0
Australia
Query!
Funding source category [2]
303876
0
Government body
Query!
Name [2]
303876
0
NSW Ministry of Health
Query!
Address [2]
303876
0
73 Miller Street
North Sydney NSW Australia
Query!
Country [2]
303876
0
Australia
Query!
Funding source category [3]
303877
0
Government body
Query!
Name [3]
303877
0
Northern Health Science Alliance Ltd.
Query!
Address [3]
303877
0
Weightmans LLP
Hardman Square
No 1 Spinningfields
Manchester M3 3EB
Query!
Country [3]
303877
0
United Kingdom
Query!
Funding source category [4]
303889
0
Government body
Query!
Name [4]
303889
0
National Institute for Health Research
Query!
Address [4]
303889
0
Grange House
15 Church street
Twickenham
TW1 3NL
Query!
Country [4]
303889
0
United Kingdom
Query!
Primary sponsor type
Other
Query!
Name
Neuroscience Research Australia
Query!
Address
Neuroscience Research Australia
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Query!
Country
Australia
Query!
Secondary sponsor category [1]
303063
0
Other
Query!
Name [1]
303063
0
The University of Manchester
Query!
Address [1]
303063
0
School of Health Sciences
Oxford Road
Manchester M13 9PL
Query!
Country [1]
303063
0
United Kingdom
Query!
Other collaborator category [1]
280963
0
Hospital
Query!
Name [1]
280963
0
Austin Health
Query!
Address [1]
280963
0
Level 8, Harold Stokes Building, Austin Health
145 Studley Rd
Heidelberg VIC 3084
Query!
Country [1]
280963
0
Australia
Query!
Other collaborator category [2]
280964
0
Government body
Query!
Name [2]
280964
0
Mid North Coast Local Health District
Query!
Address [2]
280964
0
19-31 Morton Street
Port Macquarie NSW 2444
Query!
Country [2]
280964
0
Australia
Query!
Other collaborator category [3]
280965
0
Government body
Query!
Name [3]
280965
0
Northern NSW Local Health District
Query!
Address [3]
280965
0
31 Uralba Street
Lismore NSW 2480
Query!
Country [3]
280965
0
Australia
Query!
Other collaborator category [4]
280966
0
Individual
Query!
Name [4]
280966
0
Professor Chris Todd
Query!
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
Query!
Country [4]
280966
0
United Kingdom
Query!
Other collaborator category [5]
280967
0
Individual
Query!
Name [5]
280967
0
Dr Helen Hawley-Hague
Query!
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
Query!
Country [5]
280967
0
United Kingdom
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
303610
0
South Eastern Sydney Local Health District HREC
Query!
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
Query!
Ethics committee country [1]
303610
0
Australia
Query!
Date submitted for ethics approval [1]
303610
0
28/11/2018
Query!
Approval date [1]
303610
0
28/02/2019
Query!
Ethics approval number [1]
303610
0
HREC 18/288
Query!
Ethics committee name [2]
304384
0
Research Ethics Service
Query!
Ethics committee address [2]
304384
0
Health Research Authority Skipton House 80 London Road London SE1 6LH
Query!
Ethics committee country [2]
304384
0
United Kingdom
Query!
Date submitted for ethics approval [2]
304384
0
07/10/2019
Query!
Approval date [2]
304384
0
Query!
Ethics approval number [2]
304384
0
Query!
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.
Query!
Trial website
www.standingtall.org.au
Query!
Trial related presentations / publications
Query!
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.
Query!
Contacts
Principal investigator
Name
94250
0
A/Prof Kim Delbaere
Query!
Address
94250
0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Query!
Country
94250
0
Australia
Query!
Phone
94250
0
+612 9399 1066
Query!
Fax
94250
0
+612 9399 1204
Query!
Email
94250
0
k.delbaere@neura.edu.au
Query!
Contact person for public queries
Name
94251
0
Kim Delbaere
Query!
Address
94251
0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Query!
Country
94251
0
Australia
Query!
Phone
94251
0
+612 9399 1066
Query!
Fax
94251
0
+612 9399 1204
Query!
Email
94251
0
k.delbaere@neura.edu.au
Query!
Contact person for scientific queries
Name
94252
0
Morag Taylor
Query!
Address
94252
0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Query!
Country
94252
0
Australia
Query!
Phone
94252
0
+612 9399 1885
Query!
Fax
94252
0
+612 9399 1204
Query!
Email
94252
0
m.taylor@neura.edu.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
No ethical approval to share individual participant data.
Query!
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.
Download to PDF