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Trial registered on ANZCTR


Registration number
ACTRN12621000938808
Ethics application status
Approved
Date submitted
30/09/2020
Date registered
19/07/2021
Date last updated
8/09/2022
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing affordable technology to improve mobility and physical activity in an inpatient rehabilitation setting; a feasibility study.
Scientific title
Investigating the feasibility of implementing a digitally enabled environment in rehabilitation on mobility and physical activity outcomes with Activity and MObility Using Technology (AMOUNT); a hybrid type II feasibility RCT.
Secondary ID [1] 301525 0
Nil Known
Universal Trial Number (UTN)
U1111-1253-6639
Trial acronym
AMOUNT_Implement
Linked study record
ACTRN12614000936628 is the parent study or the first phase of the current study.

Health condition
Health condition(s) or problem(s) studied:
Mobility limitations
 317885 0
Physical inactivity 317886 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315926 315926 0 0
Physiotherapy
Neurological 315927 315927 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a hybrid type II feasibility randomised control trial and therefore has two separate intervention components: 1) the implementation strategies delivered by the research team to physiotherapists to enable them to use the clinical intervention (digitally enabled rehabilitation) in practice; and 2) the clinical intervention (digitally enabled rehabilitation) delivered by physiotherapists to people undertaking inpatient aged care and neurological rehabilitation.
Implementation strategies:
The COM-B model of behaviour change has been used to design the implementation strategies to address the identified barriers to implementation identified from the AMOUNT trial and related qualitative work (access to devices, lack of training and support to use devices, IT problems). The COM-B intervention functions to be used include education, training, enablement, and environmental restructuring. A clinical champion who is a clinical physiotherapist at the site will be identified and trained by the Chief Investigator (Physiotherapist, Manager of parent AMOUNT trial (ACTRN12614000936628), who developed the original intervention protocol) and research physiotherapist (delivered intervention in parent AMOUNT trial (ACTRN12614000936628) in the use of digital devices and the intervention protocol. Digital devices will be loaned to the study site. The physiotherapy team will be provided with resources (e.g., intervention protocol) and face-to-face education and training through two workshops held approximately three months apart. The first workshop will be run for about 3 hours by the Chief Investigator and the research physiotherapist who conducted the phase 1 (ACTRN12614000936628) of this study at least 6 months before the trial is open for patient recruitment. The workshops will involve education on current evidence, hands-on practical sessions using different devices, case studies from the AMOUNT trial, and discussion and planning with the clinical team on how to embed the use of digital devices into practice to ensure quality and quantity of practice for patients randomised to the clinical intervention group. After the first workshop, the clinical physiotherapy team will be facilitated by the Clinical Champion to start using the devices (and intervention protocol) in clinical practice by regular clinical reasoning sessions. Audit and feedback of practice sheets will be used to provide feedback to clinical physiotherapists in the quality and quantity of digitally enabled rehabilitation delivered and their recording of usual practice dosage. The second workshop will be conducted 3 months from the first workshop by the research team including the Clinical Champion, which will run for about 3 hours. This workshop will overview progress to date, experiences of using devices, embedding devices into practice, recording dosage of practice and trial recruitment. Ongoing support will be provided by the Clinical Champion weekly to the clinicians as needed until the end of clinical intervention. New staff and students commencing on the rehabilitation ward after the initial workshops will have a one-hour lecture on use of digital devices (based on what was presented in Workshop 1) delivered by the Chief Investigator and one-on-one sessions with the Clinical Champion as part of their clinical practice to teach use of the different devices and clinically reason use of devices with their patients. A training log will be kept by the Clinical Champion to monitor staff training and delivery of implementation strategies.

Clinical intervention (digitally enabled rehabilitation):
Patients randomised to the clinical intervention group will receive tailored prescription of digital devices to improve mobility and increase physical activity in addition to the usual care in an inpatient rehabilitation unit of a public hospital. The additional devices will be prescribed by a clinical physiotherapist based on baseline assessment, participant goals and preferences, and the device (and games or exercises within that device) suitable to address their mobility limitations in accordance with the intervention protocol. The additional intervention devices will be provided between 30 and 60 minutes daily for five or more days per week. The total duration of the intervention will be for 3 weeks after randomisation.

The prescription of digital devices to target mobility and physical activity problems may include, but will not be limited to recreational virtual reality systems (e.g. Nintendo Wii, Xbox Kinect), rehabilitation virtual reality systems (e.g. Humac, Fysiogaming, Lusio), exercise applications on tablets or smartphones (e.g. physiotherapyexercises) and activity monitors (e.g. StepWatch).
Each device will 1) provide feedback about task performance; 2) enable individualised tailoring and progression of exercise or physical activity; 3) enables progress towards a functionally relevant goal(s); and 4) is relatively inexpensive.
The clinical physiotherapist will teach participants to use the devices and will develop individualised exercise procedures to enable participants to use the technology safely to increase dose of practice. The exercises will be mostly functional exercises like sit-to-stand, stepping, walking etc. as well as individualised strengthening exercises like dorsiflexion, knee flexion in sitting etc. The types of exercises, devices used, and the repetition/duration of the exercises done by the participant using digital devices will be recorded in a digital devices practice sheet completed by clinical physiotherapist. Data on dosage of practice from devices that store this data (e.g., Fysiogaming) will be exported by the Clinical Champion and saved with the digital device practice sheets. 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.

The trial will also embed a qualitative sub-study in which the experiences and attitudes of physiotherapists delivering digitally-enabled rehabilitation to adults with decreased mobility will be explored. All physiotherapy clinicians with involvement in the delivery of the intervention will be invited to attend a focus group conducted by a researcher not directly involved in the trial intervention. Focus groups will be run during embedding the digital devices into practice before the trial begins and towards the end of the trial to capture data from all physiotherapists that take part in the trial due to staff changes (e.g., rotations, staff resignations) throughout the trial. The Normalization Process Theory, the Consolidated Framework for Implementation Research (CFIR) and the Consolidated Criteria for Reporting Qualitative Research (COREQ) will guide the conduct and reporting of the qualitative part of the study.
Intervention code [1] 317884 0
Rehabilitation
Intervention code [2] 317885 0
Treatment: Devices
Intervention code [3] 317886 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. The usual inpatient care includes 1-2 hours of physiotherapy 5 days a week.
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. The usual practice will be recorded in a usual care practice sheet. Participants will also receive assessment and management by other health professionals of the multidisciplinary team 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.
Control group
Active

Outcomes
Primary outcome [1] 324197 0
Feasibility outcome: Percentage of usual care (both groups) and digital device (intervention group only) practice sheets complete and legible, These practice sheets are completed by clinical physiotherapists and detail the type and amount of exercises done in rehabilitation with and without the use of digital devices respectively. Feasibility criteria: complete sheets for > or = 85% participants.
Timepoint [1] 324197 0
At the end of the trial - after the last enrolled participant has completed the trial.
Primary outcome [2] 324198 0
Feasibility outcome: Average number of participants recruited into the study per week determined from the screening log. Feasibility criteria: nil.
Timepoint [2] 324198 0
At the end of the trial - after the last enrolled participant has completed the trial
Primary outcome [3] 327512 0
Feasibility outcome: Average total active time in minutes per day using digital devices for mobility tasks collected from digital device and usual care practice sheets (both groups). Feasibility criteria: average of > or = 30mins per day for >50% intervention participants; 0mins per day for >90% control participants (to confirm no contamination).
Timepoint [3] 327512 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [1] 383991 0
Patient level outcome: Short Physical Performance Battery (SPPB) (continuous version),
also known as the lower extremity continuous summary performance score, which uses actual time taken to complete mobility tasks. Scores range from 0 (worst performance) to 3 (best performance) and are based on timed gait speed over 4-m, standing balance with feet positioned parallel, semi-tandem and tandem, and standing up from a chair five times. The continuous version has been suggested as more likely to be able to detect change than the 12-point version.
Timepoint [1] 383991 0
Baseline and 3 weeks post randomisation
Secondary outcome [2] 394423 0
Patient level outcome: Timed single leg stance (max 10 seconds).
Timepoint [2] 394423 0
Baseline and 3 weeks post randomisation
Secondary outcome [3] 394424 0
Patient level outcome; Maximal balance range test measuring maximum anterior posterior displacement in mm.
Timepoint [3] 394424 0
Baseline and 3 weeks post randomisation
Secondary outcome [4] 394425 0
Patient level outcome: Step test, number of times the participant is able to step one foot on, then off, a 7.5cm block as quickly as possible in 15secs. The average number of steps between the two legs is the variable calculated.
Timepoint [4] 394425 0
Baseline and 3 weeks post randomisation
Secondary outcome [5] 394427 0
Patient level outcome: Activity Measure for Post Acute Care (AM-PAC) 12 item version.
Timepoint [5] 394427 0
Baseline and 3 weeks post randomisation
Secondary outcome [6] 394429 0
Patient level outcome: Quality of life: EQ5D-5L
Timepoint [6] 394429 0
Baseline and 3 weeks post randomisation
Secondary outcome [7] 394430 0
Patient level outcome: Average steps per day measured over a 3-day period (1 day at
baseline) using the StepWatch activity monitor
Timepoint [7] 394430 0
Baseline and 3 weeks post randomisation
Secondary outcome [8] 394431 0
Patient level outcome: Adverse events: Falls and fall related injuries (from hospital incident reporting
system)
Timepoint [8] 394431 0
Baseline to end of inpatient stay
Secondary outcome [9] 394432 0
Implementation determinants: Change in physiotherapists Capability, Opportunity and Motivation to prescribing and delivering rehabilitation using digital devices, measured using a study specific questionnaire, developed based upon the COM-B self-evaluation questionnaire.
Timepoint [9] 394432 0
End of workshop 1 and workshop 2, and during implementation period.
Secondary outcome [10] 395468 0
Feasibility outcome: Proportion of patient screened who were eligible and ineligible, and reasons why they were ineligible, collected from screening log.
Timepoint [10] 395468 0
At the end of the trial - after the last enrolled participant has completed the trial.
Secondary outcome [11] 395471 0
Feasibility outcome: Proportion of people screening who were eligible who declined taking part in the study and the reasons why they decline. This will be collected from the screening log.
Timepoint [11] 395471 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [12] 395472 0
Feasibility outcome: Number of participants who have a 3-week assessment completed (primary outcome measure) prior to discharge between 2-4 weeks post randomisation. This will be collected from REDCap study completion form. Feasibility criteria: > or = 85% completed for all outcome measures except physical activity (> or = 80%).
Timepoint [12] 395472 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [13] 395473 0
Feasibility outcome: Number and cost of devices and consumables (e.g., data cards) needed throughout the implementation phase and trial, recorded using an equipment management log.
Timepoint [13] 395473 0
At the end of the trial - after the last enrolled participant has completed the trial.
Secondary outcome [14] 395474 0
Feasibility outcome: Number of lost or broken devices needing replacement throughout the implementation phase and trial, recorded using an equipment management log.
Timepoint [14] 395474 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [15] 395475 0
Feasibility outcome: Number of times the devices did not work, time needed to fix it, how and who fixed it and the cost of fixing it. This will be collected using equipment management log.
Timepoint [15] 395475 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [16] 395476 0
Feasibility outcome: Total number of FTE staff within physiotherapy rehabilitation team that are participating in the trial. This will be collected using the staff and students training log.
Timepoint [16] 395476 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [17] 395477 0
Feasibility outcome: Number of physiotherapists and physiotherapy students that were trained over the course of project and the number of hours spent training them in using digital devices. This will be recorded in the staff and students training log.
Timepoint [17] 395477 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [18] 395478 0
Feasibility outcome: Number of training sessions missed by staff and students and the reasons why? This will be collected in the staff and students training log.
Timepoint [18] 395478 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [19] 395479 0
Feasibility outcome: Number of staff trained and conducting screening, recruitment and outcome assessment. This will be collected using the staff and students training log.
Timepoint [19] 395479 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [20] 395480 0
Feasibility outcome: Hours spent by Clinical Champion and study investigators in staff training. This will be collected using the staff and students training log.
Timepoint [20] 395480 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [21] 395481 0
Feasibility outcome: Total number of training activities performed (workshops, journal clubs, clinical reasoning sessions and audit and feedback). This will be collected from the staff and students training log.
Timepoint [21] 395481 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [22] 395482 0
Feasibility outcome: Number of devices that dosage data was successfully retrieved from. This will be collected from digital devices practice sheets.
Timepoint [22] 395482 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [23] 395483 0
Feasibility outcome: Who collected and how was dosage data collected for technology use? This will be collected from the digital devices practice sheets.
Timepoint [23] 395483 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [24] 395484 0
Patient level outcome: Number and type of adverse events when using digital devices in practice. This will collected using the Adverse events collection form.
Timepoint [24] 395484 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [25] 395487 0
Feasibility outcome: Number of days over 3-week intervention that digital devices were not used by participants randomised to the intervention group and why? This will be collected from the digital devices practice sheets.
Timepoint [25] 395487 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [26] 395488 0
Feasibility outcome: Percentage of participants in the intervention group that used each digital device. This will be collected from digital devices practice sheets.
Timepoint [26] 395488 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [27] 395489 0
Feasibility outcome: Percentage of participants each mobility task was trained with digital devices. This will be collected using digital devices practice sheets.
Timepoint [27] 395489 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [28] 395490 0
Feasibility outcome: Percentage of staff trained that participated in prescribing and delivering rehabilitation using digital devices. This will be collected using the staff training log and digital device practice sheets.
Timepoint [28] 395490 0
At the end of the trial - after the last enrolled participant has completed the trial
Secondary outcome [29] 395660 0
Patient-level outcome: Mobility task performance will be measured using the 12-point (total score and subscale scores) of the Short Physical Performance Battery (SPPB). The SPPB is a composite performance-based measure of gait, sit-to-stand and standing balance.

The secondary outcome measure 29, 'The SPPB', is a composite score while the secondary outcome measure 1, Short Physical Performance Battery (SPPB) also known as the lower extremity continuous summary performance score is a continuous score and will be reported as two separate scores and the reason why both are mentioned here, Though they sound similar, they are different.
Timepoint [29] 395660 0
At baseline and 3 weeks post randomisation.
Secondary outcome [30] 397784 0
Qualitative outcome measure: Focus Groups - to capture the experiences and attitudes of physiotherapists delivering digitally-enabled rehabilitation.
Timepoint [30] 397784 0
Towards the end of the trial.

Eligibility
Key inclusion criteria
Patients receiving the clinical intervention:
Adults admitted to the Prince of Wales Hospital for rehabilitation with
• reduced mobility (Short Physical Performance Battery score of less than 12/12)
• a clinician-assessed capacity for improvement in mobility
• a likely life expectancy of more than 6 months, estimated by a score of three or less on a modified version of the Implicit Illness Severity Scale
• an anticipated length of stay of at least 3 weeks from the date of randomisation

Therapists receiving the implementation strategies and delivering the clinical intervention:
Eligible therapists will be physiotherapists employed within SESLHD who provide inpatient rehabilitation to people with decreased mobility in the Rehabilitation ward (Parks 1 West) of Prince of Wales Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for patient-participants will be:
• a marked cognitive impairment (MMSE <24 or MoCA <18) unless caregiver present and willing and able to use digital devices with patient
• insufficient English language skills to participate in rehabilitation.
• inadequate vision to use the devices (less than 6/18 on the Snellen Chart)
• a medical condition precluding exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm or a weight-bearing restriction)
• inability to balance safely in standing despite the assistance of a staff member or the nominated support person or walking aid

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)
The trial will use a centralised web based randomisation system using REDCap (Research Electronic Data Capture) within The University of Sydney license. The randomisation schedule will be prepared and uploaded into REDCap by a study member not involved in the recruitment process. This will ensure concealment of allocation to groups and an auditable process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable block randomisation schedule will be prepared using the Sampsi command in STATA v14 by a researcher not involved in the recruitment in the trial. The randomisation schedule will incorporate stratification for baseline mobility (SPPB score >=6 vs. SPPB score <6) and health condition (neurological vs. non-neurological health condition).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
A total of 30 participants (15 per group) will be recruited. This sample will be a
representative of the target population and will be based on the same inclusion and
exclusion of a fully powered randomised control trial. Therefore, this sample size is large
enough to provide information about key aspects of feasibility measures being assessed.

Quantitative analysis
Quantitative analysis will be conducted using STATA statistical software. The feasibility
outcomes under processes (e.g. recruitment rate), resources (e.g. number of devices) and
management (e.g. completion of practice sheets) will be descriptively analysed using
frequencies, total numbers and percentages or proportions. For the scientific data (e.g.
patient-level outcomes), the main (intention-to-treat (ITT)) dataset analysed will be
constituted of all patients randomised into the study irrespective of adherence to
interventions. Between-group comparisons for each of the continuously scored outcome
measures will be made using linear models with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary
analyses will be pre-planned and conducted while masked to group allocation. All analyses will be overseen by Investigator Sherrington.

Qualitative Analysis
Audio-recordings of focus groups will be transcribed verbatim and imported into NVivo
10 (version 10 produced by QSR International, Melbourne, VIC, Australia), a qualitative
software program, to assist in the process of data analysis. The Consolidated Framework
for Implementation Research (CFIR) will be used to code the data into implementation
themes where relevant. Data will be analysed guided by our research question and using
framework analysis as described by Ritchie and Spencer. Framework analysis involves
five steps: familiarisation with the data, identifying a thematic framework, indexing,
charting, mapping and interpretation. Free codes will be used where the coding frame
was considered to have gaps.. Participants will be invited to review a de-identified
summary of the transcript and add comments (i.e. member checking).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
15/11/2021
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
29/03/2023
Actual
Sample size
Target
30
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16956 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 30613 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 305966 0
Charities/Societies/Foundations
Name [1] 305966 0
The Prince of Wales Hospital Foundation
Country [1] 305966 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
320-346 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 306424 0
University
Name [1] 306424 0
The University of Sydney
Address [1] 306424 0
Sydney School of Health Sciences, Susan Wakil Health Building, University of Sydney.
Western Ave, Camperdown, NSW 2050.
Country [1] 306424 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306206 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 306206 0
Ethics committee country [1] 306206 0
Australia
Date submitted for ethics approval [1] 306206 0
21/02/2020
Approval date [1] 306206 0
09/04/2020
Ethics approval number [1] 306206 0
2019/ETH13444; 2019/STE17877

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

Contacts
Principal investigator
Name 103090 0
Dr Leanne Hassett
Address 103090 0
Sydney School of Health Sciences, Susan Wakil Health Building, The University of Sydney.
Western Ave, Camperdown, 2050, Sydney, NSW,
Country 103090 0
Australia
Phone 103090 0
+61286276251
Fax 103090 0
+61286276262
Email 103090 0
[email protected]
Contact person for public queries
Name 103091 0
Nisha Aravind
Address 103091 0
Physiotherapy Department (Rehabilitation), Prince of Wales Hospital.
320-346 Barker St, Randwick NSW 2031.
Country 103091 0
Australia
Phone 103091 0
+61 416430011
Fax 103091 0
Email 103091 0
[email protected]
Contact person for scientific queries
Name 103092 0
Leanne Hassett
Address 103092 0
Sydney School of Health Sciences, Susan Wakil Health Building, The University of Sydney.
Western Ave, Camperdown, Sydney, NSW 2050
Country 103092 0
Australia
Phone 103092 0
+61286276251
Fax 103092 0
+61286276262
Email 103092 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 patient-level data of published results.
When will data be available (start and end dates)?
When the main study results are published. No end date.
Available to whom?
Available to other researchers on request to Chief Investigator.
Available for what types of analyses?
Systematic reviews.
How or where can data be obtained?
Request to Chief Investigator by emailing to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11695Study protocol    It is planned a study protocol will be published i... [More Details]
11696Statistical analysis plan    It is planned the statistical analysis plan will b... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementing digital devices to increase mobility training for people receiving inpatient rehabilitation: protocol for a feasibility hybrid type II randomized controlled trial.2023https://dx.doi.org/10.1186/s40814-023-01298-y
N.B. These documents automatically identified may not have been verified by the study sponsor.