Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000447550
Ethics application status
Approved
Date submitted
18/12/2023
Date registered
11/04/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
11/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of using wearable activity trackers during rehabilitation
Scientific title
Using wearable activity trackers to promote activity during rehabilitation in inpatients and outpatients at a rehabilitation hospital: a single-group feasibility study.
Secondary ID [1] 311207 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical rehabilitation 332393 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329095 329095 0 0
Physiotherapy
Physical Medicine / Rehabilitation 329336 329336 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in an inpatient Virtual Rehabilitation Ward (VRW) and an outpatient Falls, Fracture, Frailty Intervention Team (FIT) program will be provided with wearable activity trackers (WATs) and will receive information and guidance on goal setting, activity feedback, and self-monitoring by trained clinicians. This will be conducted within patients’ usual clinical appointments.

• Physical activity monitoring will last for the duration of the participants’ admission. We anticipate this will be 2-4 weeks in the VRW, and approx. 6 weeks in the FIT program, the typical admission duration for each service.

• The WATs will be used for two main purposes : promoting patient activity during rehabilitation, and measuring patient activity for data collection. Activity promotion will target walking, which will involve goal setting based on daily step counts, patient self-monitoring via the device interface and application, and feedback on progress based on daily step counts.

• Exercise Physiologists (EPs) and Physiotherapists (PTs) working in each service will lead protocol delivery, including initial assessments and goal-setting based on WAT metrics. Goals will include a daily step goal that is gradually progressed over the course of the admission.

• Participating patients will track their daily steps, and EPs/PTs will adjust goals, provide encouragement and support for patients, and troubleshoot as needed.

• Setting and reviewing goals will occur during every therapy session with the EPs/PTs (approx. 3x weekly). Activity feedback and self-monitoring will occur daily and throughout the day as the patient's use WATs to track and work toward their daily step goals.

• Patients will be asked to wear WATs during waking and sleep hours. The WATs are water resistant and can be worn during bathing. Patients will be able to remove WATs while sleeping or bathing for comfort if they prefer, or if required for any other necessary purpose (i.e. if it needs to be removed to take another health measure). Patients will be asked to wear WATs for a minimum of 12 waking hours, but encouraged to wear for more to capture more step counts.

• When participating patients complete their final assessment with EPs/PTs, their activity progress as measured by the WAT over the course of their admission will be reviewed.

• When participants are discharged, VRW patients will return their WATs to the hospital in the VRW home monitoring kits, and FIT patients will return their WAT to the hospital during their final assessment. Returned WATs will be cleaned, and patient physical activity data will be exported from devices by the researcher.

• If WAT devices are not returned when participating patients are discharged, the participant will be phoned by the researchers or an allied health assistant to arrange return (e.g. patient to bring to hospital, or arrange reply-paid postage).

• The lead researcher will set up and manage accounts for participants required for monitoring, and will also be available to meet with clinicians throughout the implementation period to provide additional support and troubleshooting of any issues that may arise.

• While patients will receive exercise programs as part of their standard rehabilitation, this intervention is additional to exercise programs prescribed as part of standard rehabilitation and the intervention will not involve additional exercise prescription other than walking. The exercise programs that patients are prescribed as part of usual rehabilitation will vary depending on their presentation, but will typically include exercises such as sit to stands, ankle dorsiflexion and plantarflexion, bicep curls, seated row, lateral raises.
Intervention code [1] 327656 0
Treatment: Devices
Intervention code [2] 327657 0
Rehabilitation
Intervention code [3] 327658 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336913 0
Patient eligibility (% of total eligible patients admitted to service)
Timepoint [1] 336913 0
At the conclusion of the implementation period (3 months).
Primary outcome [2] 336914 0
Patient acceptability and satisfaction (composite outcome)
Timepoint [2] 336914 0
This outcome ill be assessed in both subgroups at discharge (typically 2-4 weeks following admission for VRW inpatients, and 6 weeks for FIT program outpatients).
Primary outcome [3] 336915 0
Clinician experiences and perceptions (composite outcome)
Timepoint [3] 336915 0
End of protocol implementation period (3 months)
Secondary outcome [1] 430149 0
Daily step count
Timepoint [1] 430149 0
Daily step count will be measured in both subgroups. Total step counts for each day will be assessed from enrolment to discharge.

Step count will be continuously measured from baseline (patient enrolment into study) to patient follow-up at discharge (typically 2-4 weeks following admission for VRW inpatients, and 6 weeks for FIT program outpatients).
Secondary outcome [2] 431186 0
Primary outcome: Patient uptake (% of eligible patients enrolled).
Timepoint [2] 431186 0
At the conclusion of the implementation period (3 months).
Secondary outcome [3] 431187 0
Patient retention (% of patient still wearing WAM at follow-up)
Timepoint [3] 431187 0
At the conclusion of the implementation period (3 months).
Secondary outcome [4] 431188 0
Primary outcome: Device loss (% of devices lost/broken)
Timepoint [4] 431188 0
At the conclusion of the implementation period (3 months).
Secondary outcome [5] 431190 0
Primary outcome: Physical activity data completeness (% of patients with mean 18hr per day)
Timepoint [5] 431190 0
At the conclusion of the implementation period (3 months).
Secondary outcome [6] 431191 0
Primary outcome: Adverse events (e.g. falls, skin irritation from device)
Timepoint [6] 431191 0
At the conclusion of the implementation period (3 months).
Secondary outcome [7] 431192 0
Daily minutes of physical activity (PA)
Timepoint [7] 431192 0
Daily minutes of PA will be measured in both subgroups. Total minutes of PA for each day will be assessed from enrolment to discharge.

Daily minutes of PA will be continuously measured from baseline (patient enrolment into study) to patient follow-up at discharge (typically 2-4 weeks following admission for VRW inpatients, and 6 weeks for FIT program outpatients).
Secondary outcome [8] 431193 0
Daily minutes of sedentary behaviour (SB).
Timepoint [8] 431193 0
Daily minutes of SB will be measured in both subgroups. Total minutes of SB for each day will be assessed from enrolment to discharge.

Daily minutes of SB will be continuously measured from baseline (patient enrolment into study) to patient follow-up at discharge (typically 2-4 weeks following admission for VRW inpatients, and 6 weeks for FIT program outpatients).

Eligibility
Key inclusion criteria
Virtual Rehabilitation Ward
18 years old, able to ambulate independently or with stand-by assistance/supervision, have a rehabilitation goal related to increasing mobility/activity, expected length of stay of at least 2 weeks.

FIT Program
18 years old, able to ambulate independently or with stand-by assistance/supervision, own an Apple or Android smartphone (to download Fitbit application to use with Fitbit WAT device) have a rehabilitation goal related to increasing mobility/activity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Virtual Rehabilitation Ward
Lower limb amputation, delirium or cognitive impairment impacting ability to follow instructions or engage with independent behaviour change, not expected to ambulate during admission, insufficient English language to comprehend instructions regarding WAT use or no available interpreter, inadequate vision or dexterity to use devices and no available carer to help, any absolute contraindication to partaking in exercise (e.g. symptomatic severe aortic stenosis, unstable angina).

FIT Program
Lower limb amputation, delirium or cognitive impairment impacting ability to follow instructions or engage with independent behaviour change, not expected to ambulate during admission, insufficient English language to comprehend instructions regarding WAT use or no available interpreter, inadequate vision or dexterity to use devices and no available carer to help, any absolute contraindication to partaking in exercise (e.g. symptomatic severe aortic stenosis, unstable angina).

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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2024
Actual
29/05/2024
Date of last participant enrolment
Anticipated
21/08/2024
Actual
Date of last data collection
Anticipated
2/10/2024
Actual
Sample size
Target
30
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25952 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 41786 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 315466 0
Government body
Name [1] 315466 0
National Health and Medical Research Council - Medical Research Future Fund Investigator Grant (GNT1193862).
Country [1] 315466 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 317536 0
Hospital
Name [1] 317536 0
Flinders Medical Centre
Address [1] 317536 0
Flinders Dr, Bedford Park SA 5042
Country [1] 317536 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314375 0
Southern Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 314375 0
Ethics committee country [1] 314375 0
Australia
Date submitted for ethics approval [1] 314375 0
22/11/2023
Approval date [1] 314375 0
Ethics approval number [1] 314375 0
Ethics committee name [2] 315849 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 315849 0
Ethics committee country [2] 315849 0
Australia
Date submitted for ethics approval [2] 315849 0
02/02/2024
Approval date [2] 315849 0
05/02/2024
Ethics approval number [2] 315849 0
206100

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

Contacts
Principal investigator
Name 131354 0
Prof Carol Maher
Address 131354 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 131354 0
Australia
Phone 131354 0
+61 8 830 22315
Fax 131354 0
Email 131354 0
[email protected]
Contact person for public queries
Name 131355 0
Kimberley Szeto
Address 131355 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 131355 0
Australia
Phone 131355 0
+61 8 8302 2283
Fax 131355 0
Email 131355 0
[email protected]
Contact person for scientific queries
Name 131356 0
Kimberley Szeto
Address 131356 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 131356 0
Australia
Phone 131356 0
+61 8 8302 2283
Fax 131356 0
Email 131356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.