Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001097134
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
9/08/2019
Date last updated
22/12/2020
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
RECOVERY APP- The use of a smartphone based application to improve and personalize preparation for and rehabilitation of patients undergoing knee replacement surgery; a feasibility and usability study.
Scientific title
Personalised Recovery utilising the Internet of things after Major Orthopaedic (PRIMO) surgery: Optimising and personalising recovery after total knee replacement (TKR) utilising the RECOVERY app
Secondary ID [1] 298350 0
Nil known
Universal Trial Number (UTN)
U1111-1234-2424
Trial acronym
PRIMO 2 Study: Personalised Recovery utilising the Internet of things after Major Orthopaedic
surgery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis of the knee 313003 0
Acute pain 313004 0
Chronic pain 313005 0
total knee replacement 313394 0
Condition category
Condition code
Musculoskeletal 311506 311506 0 0
Osteoarthritis
Anaesthesiology 311507 311507 0 0
Pain management
Physical Medicine / Rehabilitation 311509 311509 0 0
Physiotherapy
Mental Health 311511 311511 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The RECOVERY APP will guide participants:
• With an animated surgeon which provides two separate voiced-animations (VA) that are
designed to introduce participants to the both the prehabilitation and the rehabilitation programs. A component of the study is to evaluate if participants can successfully download the Recovery App, "onboard" and learn to use the App without the assistance of a health professional as this App is intended for use in both urban and rural settings. In this pilot study, participants will download the App at 4 weeks preoperatively. At the 3 week preoperative clinic visit at RNSH, one of the project team physiotherapists will assess the participants on how successfully they have learnt to use the App and also how well they are doing their exercises.
• On a graded prehabilitation exercise program which will commence 4 weeks before total knee arthroplasty (TKA) surgery. The exercises used are the exercises that they will be expected to perform on the day of surgery, as soon as possible after they return to the ward. Participants will be expected to learn how to do the exercises from the VAs on the Recovery App and will not be given any assistance with this unless a request is made to the nominated orthopaedic registrar.
At his/ her discretion, contact can be made with nominated physiotherapists at RNSH for further explanation or assistance. In addition participants will be supplied with crutches and instructed on their use with the assistance of a VA at their preoperative visit 3 weeks before surgery if they are deemed suitable at the time of assessment.
Participants will be notified on the exercise screen how many repetitions are recommended by the physiotherapist and the participant will click on a numbers table which is a pop-up on the screen to indicate how many repetitions they achieved. Total time on prehabilitation exercises is expected to be 15-30 minutes twice per day for 4 weeks, in addition to tracking steps taken with a goal of graded increases in daily steps pre-operatively.
• on the use of active pain management strategies (pacing, mental imagery, problem solving,
managing pain flare-ups and applied relaxation) through a series of VA embedded in the APP.
• functional data and scores on self report questionnaires will be displayed in tables or graphically
• on a rehabilitation program which commences on the day of surgery and continues for 6 weeks. Rehabilitation exercises are expected to take 15-45 minutes, 3-4 times per day in addition to graded increase in daily steps taken (with reduction in gait aids as patient's balance and strength improves).
After 6 weeks participants will not be guided on exercises but will be asked to complete the same questions. Any need for further exercise progressions will be according to usual care by
physiotherapy and their surgeon. There will be a further completion at 12 weeks of the same
battery of validated psychosocial questionnaires that were completed 4 times previously during the pilot study. The exercises used in this program are voiced animations of the exercises in the AdvaNSYD Pathway of the North Shore Local Health District New South Wales Australia (NSLHD) and the animations are also approved by our project team physiotherapists.

Use of the APP will be monitored based on participant recording (or not) of number exercises completed, completion of questionnaires, APP analytics, steps taken recorded via accelerometer in phone (predicated on participants carrying phone)

Exercises included:
Prehabilitation phase- Static Quads, Heel slides, Bridges, Inner range Quadriceps, Sit to stand, Seated press-ups , Wall push ups, 1/4 squat at bar, Heel raises, Step up, Walking, Practice using crutches
Rehabilitation phase- Ankle circles, Static Quads, Heel slides, Inner range Quadriceps, Sit to stand, Seated knee flexion, Heel raises, Walking (initially with assistive devices), Knee flexion/ lunges on step, Hamstring stretch, Heel raises, Calf stretch, Balance exercises: step stance, 1/4 squat at a bar. Stair climbing and descending, Prone knee flexion: hamstring curl, Prone quadriceps stretch, Prone knee extension

The exercises included are a relatively low level of intensity when performed at low repetitions, the intensity is increased by increasing number of repetitions or number of sets of exercises.

The AdvanSYD pathway is an initiative by the NSLHD which aims to deliver excellent care for patients requiring lower limb arthroplasty by providing appropriate, efficient, equitable care which aligns with evidence based practice. This is a district wide initiative with patients related goals of patients receiving appropriate, efficient and equitable care measured through:
- Patient outcome measures are collected and evaluated; outcome measures are achieving state benchmarks.
- Reduced variation in care processes.
- Improved cost-effectiveness compared to state benchmarks.
- Informed recommendation of appropriate strategy for prostheses management; prostheses use is cost effective and clinical outcomes are maintained.

The processes used to achieve this are:
1. Providing a ‘Patient Roadmap’ that outlines appointment/steps a patient will take, and key messages e.g. that most patients return directly home
2. Patients attending a ‘Joint Class Education Session’ that reinforces these messages and allows an opportunity to answer questions.
3. A GP Letter is sent to GPs with the waitlist letter and given to patients at Joint Class
4. Anaesthesia and Analgesia Guidelines are distributed and followed as appropriate
5. A Protocol for the ‘Quickstep Group’ (Low risk patients) is followed, including:
a. Surgeons liaise with Anaesthetists regarding intraoperative recommendations
b. Surgeons direct patients to the Quickstep Protocol as appropriate, and orthopaedic ward staff follow the protocol as per role
c. A ‘Patient Recovery Guide’ (a daily checklist) is given to patients to follow
6. A Discharge Path and Criteria including:
a. Patients are discharged using the ‘criteria led discharge’ and discharge path, with reference to the Acute Post Acute Care Outline
b. Patient follow-up and escalation is arranged as per protocol.

Within the pathway, consensus recommendations for typical anesthetic/analgesic treatments and typical mobilization/ exercises have been developed.

Intervention code [1] 314590 0
Rehabilitation
Intervention code [2] 314813 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320216 0
Qualitative feedback regarding technology and process from patients
Collected via study specific questionnaire with room for free-form responses
Specifically:
Ease of use or barriers to use
Issues with APP software/video downloading or latency in use
Timepoint [1] 320216 0
6 weeks post surgery (10 weeks of use)
- also collected 3 weeks before surgery (1 week of use) and 12 weeks after surgery (16 weeks of use)
Primary outcome [2] 320698 0
Qualitative feedback regarding technology and process from clinicians
Collected via study specific questionnaire with room for free-form responses
Specifically:
Ease of use or barriers to use (for self and patient)
Issues with APP software/video downloading or latency in use
Ability to engage with patients via APP
Assessment of patient's ability to engage with APP
Timepoint [2] 320698 0
6 weeks post surgery (10 weeks of use)
- also collected 3 weeks before surgery (1 week of use) and 12 weeks after surgery (16 weeks of use)
Secondary outcome [1] 370881 0
System Usability Scale (SUS) score
Timepoint [1] 370881 0
3 weeks before surgery, 6 weeks post surgery, 12 weeks post surgery
Secondary outcome [2] 370886 0
Depression and anxiety questionaire scores- DASS 21
Timepoint [2] 370886 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [3] 370889 0
Pain self-efficacy questionaire scores
Timepoint [3] 370889 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [4] 370942 0
Pain and function of the knee- Oxford knee score (OKS)
Timepoint [4] 370942 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [5] 370943 0
Knee associated symptoms and function- Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [5] 370943 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [6] 370944 0
General domains of health and functioning- short questionnaire scores- Patient-Reported Outcomes Measurement Information System (Promis-10)
Timepoint [6] 370944 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [7] 370945 0
Assessment of amount that negative beliefs (in particular catastrophic thoughts and fear avoidant patterns) occur in patient- Pain Catastrophising Questionnaire
Timepoint [7] 370945 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [8] 370946 0
Self report daily Opioid use
Timepoint [8] 370946 0
Daily recording in application by patient during trial
Secondary outcome [9] 370947 0
VAS scored response to question (not validated tool)
How much the pain is bothering them
Timepoint [9] 370947 0
Daily recording in application by patient during the trial
Secondary outcome [10] 370948 0
Participant self report of number of repetitions of prescribed exercises completed
Timepoint [10] 370948 0
Daily recording by patients in application
Secondary outcome [11] 370949 0
Number of steps per day
(Distance walked as measured by the Health app, and HealthKit-enabled apps on iPhone which are open framework.)
Timepoint [11] 370949 0
Daily recording by application during trial
Secondary outcome [12] 370975 0
Knee pain, stiffness and functional limitation- WOMAC assessment tool
Timepoint [12] 370975 0
4 weeks pre-operatively
immediately pre-operatively
2 weeks post-operative
6 weeks post-operative
12 weeks post-operative
Secondary outcome [13] 372565 0
VAS scored response to question (not validated tool)

Happiness with their progress,
Timepoint [13] 372565 0
Daily recording in application by patient during the trial
Secondary outcome [14] 372566 0
VAS scored response to question (not validated tool)

Their confidence to continue with the program
Timepoint [14] 372566 0
Daily recording in application by patient during the trial

Eligibility
Key inclusion criteria
Participants
- wait-listed for a TKA at RNSH with planned surgery date at least 8 weeks from
time of contact who are willing to give consent and to participate and comply with
the requirements of the study.
- who are willing to engage with an internet-based functional monitoring and treatment
program.
- who are willing and able to use a smartphone.
- who have internet access
- who are able to complete self-report functional and psychosocial questionnaires
and patient reported outcome measures (PROM)
- who are able to attend the physiotherapy outpatients at their treating hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- have significant medical or psychiatric co-morbid conditions that would limit participation.
- having bilateral TKA
- who are not willing to engage with an internet-based functional monitoring and
treatment program
- unwilling or unable to complete a series of validated psychological and functional
self-report questionnaires

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)
There is no allocation, so no allocation concealment
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
Efficacy
Statistical methods / analysis
As this is a pilot study and therefore no statistical hypothesis testing will be conducted,
sample size is based on practical considerations. We estimated that a full randomised
controlled trial would require 300 patients, so for this pilot study we have selected 10% of
this number, so 30 patients be will studied. As no account will be taken of preoperative
functional status or social support available postoperatively, some participants may not be
discharged home and will go to inpatient rehabilitation. Inpatient rehabilitation takes place
at a number of sites so it is unrealistic to obtain site specific approval for this pilot study to
be performed at all these potential centres so these participants will be recorded as
"ineligible postoperatively". This may mean that more than 30 participants are enrolled to
achieve our pilot number of 30 participants. The in-patient rehabilitation rate is less than
20% in public hospitals so total enrolled participants should not exceed 40.

Descriptive statistical analysis will be used, as there is no comparator group we do not have pre-described comparative statistics planned.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/08/2019
Actual
11/09/2019
Date of last participant enrolment
Anticipated
13/08/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
80
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13853 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13854 0
Ryde Hospital - Eastwood
Recruitment hospital [3] 13855 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 26624 0
2065 - St Leonards
Recruitment postcode(s) [2] 26625 0
2122 - Eastwood
Recruitment postcode(s) [3] 26626 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 302887 0
Self funded/Unfunded
Name [1] 302887 0
A/Prof Allan Molloy
Country [1] 302887 0
Australia
Funding source category [2] 303282 0
Government body
Name [2] 303282 0
North Sydney Local Health District
Country [2] 303282 0
Australia
Primary sponsor type
Government body
Name
North Shore Local Health District
Address
Douglas Building,
Level 5,
Royal North Shore Hospital Campus,
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 302842 0
None
Name [1] 302842 0
Address [1] 302842 0
Country [1] 302842 0
Other collaborator category [1] 280718 0
Commercial sector/Industry
Name [1] 280718 0
Servian Pty Ltd
Address [1] 280718 0
Level 46
Australia Square Tower
264 George Street
Sydney NSW 2000
Country [1] 280718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303462 0
Northern Sydney Local Health District Human Research Ethics Committee (NSLHD HREC)
Ethics committee address [1] 303462 0
Ethics committee country [1] 303462 0
Australia
Date submitted for ethics approval [1] 303462 0
15/04/2019
Approval date [1] 303462 0
07/05/2019
Ethics approval number [1] 303462 0
2019/ETH09847

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

Contacts
Principal investigator
Name 93742 0
Dr Andrew Weiss
Address 93742 0
Pain Management and Research Institute
Royal North Shore Hospital,
Reserve Road,
St Leonards NSW 2065
Australia
Country 93742 0
Australia
Phone 93742 0
+61 02 9463 1500
Fax 93742 0
Email 93742 0
andrew.weiss@health.nsw.gov.au
Contact person for public queries
Name 93743 0
Andrew Weiss
Address 93743 0
Pain Management and Research Institute
Royal North Shore Hospital,
Reserve Road,
St Leonards NSW 2065
Australia
Country 93743 0
Australia
Phone 93743 0
+61 02 9463 1500
Fax 93743 0
Email 93743 0
andrew.weiss@health.nsw.gov.au
Contact person for scientific queries
Name 93744 0
Andrew Weiss
Address 93744 0
Pain Management and Research Institute
Royal North Shore Hospital,
Reserve Road,
St Leonards NSW 2065
Australia
Country 93744 0
Australia
Phone 93744 0
+61 02 9463 1500
Fax 93744 0
Email 93744 0
andrew.weiss@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethics application that has been approved, does not allow for the sharing of the referenced individual patient data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2226Ethical approval    377671-(Uploaded-12-07-2019-14-54-34)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
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