Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000936628
Ethics application status
Approved
Date submitted
15/08/2014
Date registered
2/09/2014
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Date results provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation
Scientific title
Effect of the addition of affordable technology to usual care on physical activity levels and mobility outcomes in people with mobility limitations admitted to hospital for aged care and neurological rehabilitation compared to usual care alone
Secondary ID [1] 285158 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
AMOUNT (Activity and MObility UsiNg Technology) rehabilitation trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility limitations 292748 0
Physical inactivity 292749 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293040 293040 0 0
Physiotherapy
Neurological 293205 293205 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive tailored technology use in addition to usual care. The research physiotherapist will determine the most appropriate intervention based on discussion with the clinical physiotherapist, baseline assessment, participant goals, and the technology suitable in accordance with the intervention protocol. In addition to usual therapy each participant will be asked to use the intervention technologies between 30 and 60 minutes daily for five or more days per week. The total duration of the intervention will be six months after randomisation and will incorporate both inpatient rehabilitation and post-discharge settings.

The prescription of technology to target mobility and physical activity problems will include, but will not be limited to, the use of video, computer and tablet programs and applications to encourage structured exercise and other forms of physical activity as well as pedometers to monitor activity levels. The chosen technologies are all relatively low cost and will provide feedback on mobility task or physical activity performance or dose. Some of the technologies involve games. The research physiotherapist will choose the most appropriate technology/ies for an individual patient by following a protocol refined through pilot testing. The exercise protocol guide will be reviewed quarterly and any new technologies will be added throughout the trial.

Each technology used 1) provides feedback about task performance; 2) facilitates individualised tailoring and progression of exercise or physical activity; 3) enables progress towards a functionally relevant goal(s) to be recorded and graphed; and 4) is relatively inexpensive.

The research physiotherapist will teach participants to use the technology and will develop individualised exercise procedures to enable participants to use the technology safely outside of therapy times. If judged by staff to be safe to do so, participants will exercise unsupervised or with the supervision of family members/friends, nursing staff and hospital volunteers.

After discharge from the inpatient stay, participants will be encouraged to continue using the technologies at home. Participants will be loaned necessary equipment (stand-alone devices or games consoles, installed by study staff) and trained in the safe use and progression of the games/exercises during a home visit by the research physiotherapist. Weekly support via telephone, email or videoconference will be provided during this phase of the study. This support will aim to assist study participants to maintain motivation and will identify and address any barriers to technology use at home. Up to five home visits will be provided to manage technology issues and/or progression.

Goals will be set collaboratively with each participant and recorded and reviewed throughout the intervention phase. Practice sheets and information from some of the devices (e.g. game play time, number of steps walked) will be used to monitor the dose of the intervention.
Intervention code [1] 290008 0
Rehabilitation
Intervention code [2] 290009 0
Lifestyle
Intervention code [3] 290010 0
Behaviour
Comparator / control treatment
The control group will receive usual rehabilitation care as prescribed during admission to hospital and post discharge from hospital according to current practice.

Participants in both groups will receive usual rehabilitation care (inpatient and outpatient). All participants will be assessed by a physiotherapist who will prescribe a series of repetitive exercises (e.g. practise of standing up or stepping). The conduct of these exercises will be supervised by the physiotherapist, a physiotherapy assistant or family member. Participants will also receive assessment and management by medical specialists, nurses, occupational therapists and speech pathologists, social workers, nutritionists, orthoptists or other health professionals as required. At the time of discharge, participants will be referred to follow-up outpatient therapy and/or prescribed a home exercise program in accordance with usual practice at the study sites.
Control group
Active

Outcomes
Primary outcome [1] 292907 0
Physical activity will be assessed over a 7-day period using the activPAL activity monitoring system. Using proprietary algorithms the activPAL classifies an individual's activity into periods spent sitting, standing and walking. The average number of minutes per day spent upright at 6 months will be the primary outcome.
Timepoint [1] 292907 0
At 6 months post randomisation
Primary outcome [2] 292908 0
Mobility task performance will be measured using the continuously scored version of the Short Physical Performance Battery (SPPB). The SPPB measures the “activity” aspect of mobility (as defined by the World Health Organisation's International Classification for Functioning Disability and Health).
Timepoint [2] 292908 0
At 6 months post randomisation
Secondary outcome [1] 309903 0
Physical activity will be assessed over a 7-day period using the activPAL activity monitoring system to determine the average number of minutes per day spent upright.
Timepoint [1] 309903 0
3 weeks post randomisation
Secondary outcome [2] 309904 0
Physical activity will also be assessed using the self-reported Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [2] 309904 0
3 weeks, 12 weeks and 6 months
Secondary outcome [3] 309905 0
Mobility task performance will be measured using the 12-point and continuously scored versions of the Short Physical Performance Battery (SPPB)
Timepoint [3] 309905 0
3 weeks post randomisation (both versions) and 6 months post randomisation (12-point version)
Secondary outcome [4] 309906 0
Mobility task performance will be measured by The de Morton Mobility Index (DEMMI), a 15-item unidimensional measure of mobility
Timepoint [4] 309906 0
3 weeks and 6 months post randomisation
Secondary outcome [5] 309916 0
Mobility task performance will be measured by single leg stance, maximal balance range test and the step test
Timepoint [5] 309916 0
3 weeks and 6 months post randomisation
Secondary outcome [6] 309917 0
Activity and Participation will be assessed with the World Health Organisation Disability Assessment Scale (WHODAS 2.0) 12 item, generic assessment instrument for health and disability
Timepoint [6] 309917 0
3 weeks, 12 weeks and 6 months post randomisation
Secondary outcome [7] 309918 0
Cognition will be assessed using the Trail Making Test (TMT) Parts A & B
Timepoint [7] 309918 0
3 weeks and 6 months post randomisation
Secondary outcome [8] 309919 0
Utility-based quality of life will be assessed using the SF-6D subset of the SF-36 and the EuroQOL-5D
Timepoint [8] 309919 0
3 weeks, 12 weeks and 6 months post randomisation
Secondary outcome [9] 309920 0
Falls will be assessed during the inpatient stay using routine incident documentation systems. After discharge, participants will be asked to complete a falls calendar for the remainder of time until six months post randomisation
Timepoint [9] 309920 0
Over 6 months post randomisation
Secondary outcome [10] 309921 0
Confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness will be measured with the Activities-Specific Balance Confidence Scale
Timepoint [10] 309921 0
3 weeks, 12 weeks and 6 months post randomisation
Secondary outcome [11] 309922 0
Self efficacy in using everyday technologies by older people or people with disabilities will be measured by the modified computer self efficacy scale
Timepoint [11] 309922 0
3 weeks, 12 weeks and 6 months post randomisation
Secondary outcome [12] 309923 0
“System usability”, intervention enjoyment and adherence will be calculated using records kept by staff, usage diaries kept by participants and data available from the devices themselves. The System Usability Scale and Physical Activity Enjoyment Scale (PACES) will be used.
Timepoint [12] 309923 0
3 weeks, 12 weeks and 6 months post randomisation (intervention group only)

Eligibility
Key inclusion criteria
Admitted for rehabilitation or assessment at one of the 3 study sites with:
*reduced mobility (Short Physical Performance Battery score of less than 12)
*clinician-assessed capacity for improvement in mobility
*likely life expectancy of more than 12 months
*anticipated length of stay of greater than or equal to 10 days.
*ability to maintain a standing position with 1 person assist as a minimum standard
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*marked cognitive impairment
*insufficient English language skills to participate in rehabilitation and no available interpreter
*inadequate vision to use the devices
*medical condition precluding exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm or a weight-bearing restriction)
*lack of interest in the use of the technologies
*anticipated discharge to nursing home
*discharge location too far from study site to complete home visits and follow-up assessments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients on the Aged Care and Neurological wards of the Repatriation General Hospital and Bankstown-Lidcombe Hospital, and all patients of the Liverpool Brain Injury Rehabilitation Unit will be screened for eligibility. For eligible patients who consent to participate in the study, a baseline assessment will be conducted. At the end of the assessment group allocation will be determined using concealed allocation. Concealed allocation will be achieved by central randomisation using a web-based randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation stratified for study site and health condition (whether or not the person has a neurological condition that affects their activity performance and/or participation) using a randomisation schedule created by a researcher not involved in recruitment/eligibility assessment using Microsoft excel and embedded in a RedCap database.
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
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
A total of 300 participants (150 per group) will provide 90% power to detect as significant, at the 5% level, a 15% between-group difference in both the primary outcome measures. The sample size calculation was undertaken using the sampsi command in Stata 13 and data from our pilot studies (manuscripts under preparation). The calculation assumed one pre-randomisation measure, one follow-up measure and analysis using linear models with baseline scores entered as covariates and a correlation between pre- and post measures of 0.65. For the continuously scored Short Physical Performance Battery score the intervention group mean was assumed to 1.89, the control group mean 1.64 and the standard deviation 0.75. For the activPAL the intervention group upright minutes per day was assumed to 223, the control group mean 194 and the standard deviation 90. We have allowed for a 20% dropout rate. This sample size will be sufficient to detect between-group differences of 10-15% in most of the secondary outcomes.

Statistical Analysis Plan:
Between-group comparisons for each of the continuously-scored outcome measures will be made using linear models with baseline scores entered as a covariate. The dichotomous outcomes will be compared between groups using log binomial regression. Fall rates between groups will be compared using negative binomial regression. Interaction terms will be used in the models to assess whether effects of the intervention differ according to age or a neurological versus non-neurological cause of the mobility impairment. Primary analyses will use an intention-to-treat approach. All analyses will be overseen by the study statistician.

Health and community service usage data collected from participant-completed calendars, hospital databases and medical records (length of stay, procedures, reasons for re-admission or emergency department visit) will be used to calculate health service utilisation and costs to inform the conduct of an economic evaluation. The cost of the intervention (staff and equipment) will also be calculated from trial records and used in the cost-effectiveness analysis. The Incremental Cost-Effectiveness Ratio will be calculated to assess the relative costs and benefits in terms of gain in mobility (SPPB score change) and quality of life (using the SF-6D and the EQ5D-5L).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2014
Actual
22/09/2014
Date of last participant enrolment
Anticipated
1/09/2016
Actual
10/11/2016
Date of last data collection
Anticipated
8/05/2017
Actual
11/05/2017
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 2846 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 2847 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 2848 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 8534 0
2200 - Bankstown
Recruitment postcode(s) [2] 8535 0
2170 - Liverpool
Recruitment postcode(s) [3] 8536 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 289770 0
Government body
Name [1] 289770 0
National Health and Medical Research Council
Country [1] 289770 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, Sydney Medical School, The University of Sydney
Address
PO Box M201, Missenden Road, Sydney NSW 2050
Country
Australia
Secondary sponsor category [1] 288459 0
Hospital
Name [1] 288459 0
Repatriation General Hospital
Address [1] 288459 0
Daws Road, Daws Park 5041, SA
Country [1] 288459 0
Australia
Other collaborator category [1] 278085 0
University
Name [1] 278085 0
The University of Sydney
Address [1] 278085 0
NSW 2006
Country [1] 278085 0
Australia
Other collaborator category [2] 278086 0
University
Name [2] 278086 0
Flinders University
Address [2] 278086 0
Sturt Rd, Bedford Park SA 5042
Country [2] 278086 0
Australia
Other collaborator category [3] 278087 0
University
Name [3] 278087 0
University of Tasmania
Address [3] 278087 0
Churchill Avenue, Sandy Bay, Hobart TAS 7005
Country [3] 278087 0
Australia
Other collaborator category [4] 278088 0
Hospital
Name [4] 278088 0
Bankstown-Lidcombe Hospital
Address [4] 278088 0
Eldridge Road, Bankstown NSW 2200
Country [4] 278088 0
Australia
Other collaborator category [5] 278089 0
University
Name [5] 278089 0
University of Technology Sydney
Address [5] 278089 0
15 Broadway, Ultimo NSW 2007
Country [5] 278089 0
Australia
Other collaborator category [6] 278090 0
University
Name [6] 278090 0
Macquarie University
Address [6] 278090 0
Sydney NSW 2109
Country [6] 278090 0
Australia
Other collaborator category [7] 278091 0
University
Name [7] 278091 0
Australian Catholic University
Address [7] 278091 0
PO Box 968, North Sydney NSW 2059
Country [7] 278091 0
Australia
Other collaborator category [8] 278092 0
Hospital
Name [8] 278092 0
Brain Injury Rehabilitation Unit, Liverpool Hospital
Address [8] 278092 0
Liverpool Hospital, Goulburn St & Elizabeth St, Liverpool NSW 2170
Country [8] 278092 0
Australia
Other collaborator category [9] 278098 0
University
Name [9] 278098 0
VU University Medical Center Amsterdam
Address [9] 278098 0
De Boelelaan 1117, 1081 HZ Amsterdam
Country [9] 278098 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291498 0
The Southern Adelaide Clinical Human Research Ethics
Ethics committee address [1] 291498 0
Ethics committee country [1] 291498 0
Australia
Date submitted for ethics approval [1] 291498 0
Approval date [1] 291498 0
19/12/2013
Ethics approval number [1] 291498 0
529.163 - HREC/13/SAC/359
Ethics committee name [2] 291499 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 291499 0
Ethics committee country [2] 291499 0
Australia
Date submitted for ethics approval [2] 291499 0
Approval date [2] 291499 0
04/07/2014
Ethics approval number [2] 291499 0
HREC/13/SAC/359 - SSA14LPOOL/97 (Bankstown-Lidcombe Hospital)
Ethics committee name [3] 291501 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [3] 291501 0
Ethics committee country [3] 291501 0
Australia
Date submitted for ethics approval [3] 291501 0
Approval date [3] 291501 0
04/07/2014
Ethics approval number [3] 291501 0
HREC/13/SAC/359 - SSA14LPOOL/96 (Liverpool Hospital)

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

Contacts
Principal investigator
Name 50658 0
Prof Cathie Sherrington
Address 50658 0
The George Institute for Global Health
PO Box M201, Missenden Road Sydney NSW 2050 Australia
Country 50658 0
Australia
Phone 50658 0
+61280524300
Fax 50658 0
+61280524301
Email 50658 0
[email protected]
Contact person for public queries
Name 50659 0
Leanne Hassett
Address 50659 0
The George Institute for Global Health
PO Box M201, Missenden Road Sydney NSW 2050 Australia
Country 50659 0
Australia
Phone 50659 0
+61280524300
Fax 50659 0
+61280524301
Email 50659 0
[email protected]
Contact person for scientific queries
Name 50660 0
Cathie Sherrington
Address 50660 0
The George Institute for Global Health
PO Box M201, Missenden Road Sydney NSW 2050 Australia
Country 50660 0
Australia
Phone 50660 0
+61280524300
Fax 50660 0
+61280524301
Email 50660 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?
De-identified data for primary and secondary outcomes.
When will data be available (start and end dates)?
Available from 18/02/2020.
No end date.
Available to whom?
No restrictions.
Available for what types of analyses?
No restriction.
How or where can data be obtained?
The data underlying
The results presented in the study are available
from the University of Sydney’s open access
institutional repository, Sydney eScholarship
repository: https://ses.library.usyd.edu.au/handle/
2123/21698.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12328Study protocolCitation: Hassett L, van den Berg M, Lindley RI, Crotty M, McCluskey A, van der Ploeg HP, et al. (2020) Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial. PLoS Med 17(2): e1003029. https://doi.org/10.1371/journal. pmed.1003029  
12329Statistical analysis planCitation: Hassett L, van den Berg M, Lindley RI, Crotty M, McCluskey A, van der Ploeg HP, et al. (2020) Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial. PLoS Med 17(2): e1003029. https://doi.org/10.1371/journal. pmed.1003029  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDigitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.2020https://dx.doi.org/10.1371/journal.pmed.1003029
EmbaseActivity and MObility UsiNg Technology (AMOUNT) rehabilitation trial - description of device use and physiotherapy support in the post-hospital phase.2021https://dx.doi.org/10.1080/09638288.2020.1790679
N.B. These documents automatically identified may not have been verified by the study sponsor.