Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001448235
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
28/08/2018
Date last updated
13/02/2023
Date data sharing statement initially provided
5/04/2019
Date results information initially provided
17/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The PATHway trial: health motivational strategies and tracking devices for post-surgical rehabilitation following knee replacement or spinal decompression
Scientific title
The PATHway Trial: Participatory health through behavioural engagement and disruptive digital technology for post-operative rehabilitation of lumbar decompression and total knee replacement.
Secondary ID [1] 294027 0
Nil known
Universal Trial Number (UTN)
U1111-1209-2989
Trial acronym
The PATHway Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 306715 0
low back pain 306716 0
rehabilitation post total knee replacement surgery 306718 0
rehabilitation post lumbar decompression surgery 306719 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305820 305820 0 0
Other physical medicine / rehabilitation
Musculoskeletal 305821 305821 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed intervention will consist of the clinical pathway augmented by a 6-months disruptive technology package to optimise engagement and adherence to the post-surgical rehabilitation program. The intervention will be delivered by a study coordinator through apps installed in the study iPad. The technology package will be composed of:
• a daily exercise program (please see details below) delivered via a health fitness app (PhysiApp®) which will be monitored using Physitrack® (the clinician portal)
• daily physical activity tracking using a wearable tracker (Fitbit®) built-in with motivational reminders and used in combination with the Fitbit app
• a weekly health-coaching delivered by a certified health coach via video-conferencing software (Zoom® app) and motivational text messages via iMessage (Apple®)
• a knee joint ROM measuring app (Goniometer Pro®) for total knee replacement participants to measure and record ROM during each health-coaching session

Exercise program
A 6-month exercise program was created by a physiotherapist after consultation with a surgeon, a rheumatologist and a patient representative using Physitrack®, which is specifically for lumbar decompression and total knee replacement, respectively. The exercise program focused mainly on strengthening, ROM and neural gliding exercises (the latter was limited to lumbar decompression participants). There will be no special equipment needed for the participants except for a chair or exercise mat.
Each program is comprised of 3 levels of difficulty with independent progression for strengthening and ROM/neural glide exercises.
The exercise program will be delivered to the participant via PhysiApp, which will record the participant’s adherence to the exercises (number sets and repetitions performed). Participants will be asked to rate their pain intensity experienced during exercises.

Treatment Adherence
Frequency of exercise/physical activity over the last week will be used to assess adherence. Satisfactory adherence to the intervention will be defined as completion of at least 80% of the prescribed intervention.
Adherence to the experimental intervention will be measured through a combination of self-reported and objective measures including adherence self-reported questions, data from activity devices, Physitrack app and logs maintained by the study coordinator.
Intervention code [1] 300402 0
Rehabilitation
Comparator / control treatment
The comparator treatment will be comprised of the standardised post-surgical rehabilitation care. The control will also receive an activity tracker (Fitbit) to allow the monitoring of physical activity, however without motivational messaging. To ensure participant retention, we will offer healthy lifestyle advice after each fortnightly health care usage survey. The experimental group will also receive lifestyle advice messages.
Control group
Active

Outcomes
Primary outcome [1] 304879 0
Patient-reported average pain intensity in the past week (0-10 scale)
Timepoint [1] 304879 0
3 (primary endpoint), 6 and 12 months
Secondary outcome [1] 343468 0
The patient-reported impression of change assessed by the Global Rating of Change (GRC) in pain intensity
Timepoint [1] 343468 0
3 (primary endpoint), 6 and 12 months
Secondary outcome [2] 369099 0
28-day readmission to hospital (self-reported)
Timepoint [2] 369099 0
Baseline, 3 (primary endpoint), 6, and 12 months.
Secondary outcome [3] 369100 0
Patient activity engagement, through the Active Australia Questionnaire
Timepoint [3] 369100 0
Baseline, 3 (primary endpoint), 6, and 12 months
Secondary outcome [4] 369101 0
Sedentary behaviour questionnaire (validated SBQ tool)
Timepoint [4] 369101 0
Baseline, 3 (primary endpoint), 6, and 12 months
Secondary outcome [5] 369102 0
Patient-reported pain-related disability, through the Pain Disability Index
Timepoint [5] 369102 0
Beseline, 3 (primary endpoint), 6, and 12 months
Secondary outcome [6] 369103 0
Assessment of Quality of Life-8
Timepoint [6] 369103 0
Baseline, 3 (primary endpoint), 6, and 12 months.
Secondary outcome [7] 369104 0
ActivPAL (physical activity tracking monitor) 5-day measures (step count, sitting/lying time, standing time, stepping time, number of transition from sitting to standing)
Timepoint [7] 369104 0
3 (primary endpoint), 6, and 12 months.
Secondary outcome [8] 369107 0
Health care and medication use, through data from Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS)
Timepoint [8] 369107 0
Baseline, 3 (primary endpoint), 6, and 12 months.
Secondary outcome [9] 376834 0
System usability assessed by the System Usability Scale (experimental group only)
Timepoint [9] 376834 0
3 and 6-months
Secondary outcome [10] 418483 0
Fitbit (wearable physical activity tracker) 5-day measures (step count, sedentary time, sleeping duration, time in bed)
Timepoint [10] 418483 0
3, 6 and 12 months
Secondary outcome [11] 418484 0
Patient Activation Measure (PAM) which measures a person's ability to self-care, including the knowledge, skills and confidence to participate in their own healthcare journey.
Timepoint [11] 418484 0
3,6 and 12 months

Eligibility
Key inclusion criteria
1. Ability and willingness to participate in the study
2. Familiarity with the use of the Internet and smart devices
3. Ownership of a smartphone
4. Participants must have at least functional English to be able to understand the study procedures, complete the questionnaires, communicate during the health coaching sessions and consent to participate in the study
5. aged 18 years or older, male or female
6. Admission to one of the study sites for rehabilitation following total knee replacement or lumbar decompression with or without fusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder).
2. Any clinically significant acute or ongoing chronic medical conditions (e.g., uncontrolled diabetes) that could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study.
3. Patients undergoing bilateral knee replacement.
4. Patients undergoing revision for a previous total knee replacement or spinal surgery.
5. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrolment.
6. Current use of any intervention component (activity tracker, exercises app or health coaching) and unwillingness to stop using it for the duration of the study.
7. Spinal surgery beyond two spine levels.
8. Participants beyond 45 days post-op.

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 allocation will be concealed by automated assignment using the REDCap randomisation module. Due to the type of intervention, participants and the researchers delivering the intervention will not be blinded to the treatment allocation. The site staff, principal investigators and study statistician will remain blinded to the treatment allocation until the main results are analysed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals who qualify and consent to take part in the study will be assigned to either experimental or control group with a 1:1 allocation rate as per computer-generated randomisation scheduled using random permuted block sizes and stratified by study sites. A separate randomisation schedule will be created for each type of surgery (total knee replacement and spinal surgery).
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be based on the intention-to-treat principle and conducted by surgical procedure (i.e. TKR and lumbar decompression). Statistical significance will be defined as P<0.05 on the basis of a two-sided test.

Descriptive statistics of baseline characteristics will be summarised by randomisation group and type of conditions (i.e. post-TKR and post spinal surgery). Continuous variables will be summarised as mean (SD) where appropriate or median (range). Categorical variables will be summarised as frequency (%). Pain scores as 3 months will be summarised as mean (SD) or median (range) if non-normal. The primary analysis for the difference in pain will be assessed using t-test if normally distributed or a Mann Whitney test if non-normal. Secondary outcomes including a secondary analysis of pain (at 6 and 12 months) will be investigated using generalised estimating equation, this takes into account the repeated measures of the data. Analyses will be performed separately for each condition. A time-by-treatment interaction will be included in the models alongside the main effects to assess the effect of treatment over time. Additional analyses will also be performed, adjusting the models for relevant baseline scores, demographics and clinical characteristics. In case of non-compliance with treatments before the 6 and 12-month follow-up, a sensitivity analysis (among only those who completed the follow-up questionnaire) will also be performed excluding those who were non-compliant. Missing data will be checked for randomness and data missing at random will be imputed using multiple imputations.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/11/2019
Actual
18/11/2019
Date of last participant enrolment
Anticipated
29/07/2022
Actual
27/09/2022
Date of last data collection
Anticipated
27/09/2023
Actual
Sample size
Target
204
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10079 0
Lawrence Hargrave Private Hospital - Thirroul
Recruitment hospital [2] 10080 0
Hunters Hill Private Hospital - Hunters Hill
Recruitment hospital [3] 10081 0
Mt Wilga Private Hospital - Hornsby
Recruitment hospital [4] 19671 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [5] 19672 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 21605 0
2515 - Thirroul
Recruitment postcode(s) [2] 21606 0
2110 - Hunters Hill
Recruitment postcode(s) [3] 21607 0
2077 - Hornsby
Recruitment postcode(s) [4] 34303 0
2500 - Wollongong
Recruitment postcode(s) [5] 34304 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 298653 0
Hospital
Name [1] 298653 0
Ramsay Hospital Research Foundation
Country [1] 298653 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 3, F23 Administration Building, The University of Sydney, Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 297937 0
None
Name [1] 297937 0
Address [1] 297937 0
Country [1] 297937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299608 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 299608 0
Research Integrity& Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 299608 0
Australia
Date submitted for ethics approval [1] 299608 0
23/07/2018
Approval date [1] 299608 0
08/10/2018
Ethics approval number [1] 299608 0
2018/265

Summary
Brief summary
It is estimated that 6.9 million Australians have chronic musculoskeletal conditions. More than 550,000 elective surgical procedures are performed each year in Australia for all musculoskeletal conditions and one in seven of these operations is for osteoarthritis of the knee or low back pain. The rising prevalence of these conditions and the ensuing surgical costs mean the quality of care and pricing have been identified for review. Moreover, post-surgical care, including inpatient rehabilitation for the knee and lumbar spine, is currently not standardised, sustainable or evidence-based. This contributes to substantial clinical variation and a wide range of outcomes.

The PATHway is a randomised controlled trial designed to evaluate a post-surgical rehabilitation program using disruptive technologies to increase function and physical activity for patients following inpatient rehabilitation after their total knee replacement and lumbar spinal decompression surgeries. The intervention is a post-surgical clinical pathway (standardised, evidence-based, multidisciplinary rehabilitation program) supplemented by a 6-month disruptive technology package composed of 4 components:
• an exercise program delivered via a health and fitness app (PhysiApp®)
• wearable physical activity tracker (Fitbit®) built-in with motivational reminders and used in combination with the Fitbit app
• health-coaching delivered via video calls using the Zoom app and through motivational messages delivered via iMessage
• knee joint range of motion (ROM) measuring app (Goniometer Pro®) for total knee replacement participants.
The proposed program will be compared to a control group which is akin to usual care.
The primary outcome is a change in patient-reported average pain intensity (0-10 on a Numerical Rating Scale, NRS) over the last week from baseline to 3-months. The major secondary outcomes include change of NRS from baseline to 6 and 12 months, change in patient-reported pain-related disability, change in physical activity participation (subjective and objective measures) and physical function from baseline to 3, 6 and 12 months.
The study aims to recruit a total of 204 participants (102 participants per arm) of whom 50% will have undergone knee replacement and 50% spinal surgery. Patients will be recruited from multiple study sites (hospitals and private clinics) across Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81010 0
Prof David Hunter
Address 81010 0
Level 10 Kolling Institute Department of Rheumatology Royal North Shore Hospital St Leonards NSW 2065
Country 81010 0
Australia
Phone 81010 0
+61 2 9463 1887
Fax 81010 0
Email 81010 0
[email protected]
Contact person for public queries
Name 81011 0
Ms Sarah Robbins
Address 81011 0
Level 10 Kolling Institute
Department of Rheumatology
Royal North Shore Hospital
St Leonards
NSW 2065
Country 81011 0
Australia
Phone 81011 0
+61 2 9463 1855
Fax 81011 0
Email 81011 0
[email protected]
Contact person for scientific queries
Name 81012 0
Prof David Hunter
Address 81012 0
Level 7C, Clinical Administration
Royal North Shore Hospital, Acute Services Building
Dept. of Rheumatology, University of Sydney, Northern Clinical School
St Leonards NSW 2065
Country 81012 0
Australia
Phone 81012 0
+61 2 9463 1887
Fax 81012 0
Email 81012 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?
Raw data, Statistical Analysis Plan and data dictionary
When will data be available (start and end dates)?
31/12/2025 - 31/12/2030
Available to whom?
Researchers who apply for the appropriate ethical and investigator approvals
Available for what types of analyses?
Meta analysis and other
How or where can data be obtained?
Upon request to Principal Investigators and following Sponsor and Ethical approval


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
SourceTitleYear of PublicationDOI
EmbaseParticipatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: Protocol of the PATHway trial.2021https://dx.doi.org/10.1136/bmjopen-2020-041328
N.B. These documents automatically identified may not have been verified by the study sponsor.