Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001566224p
Ethics application status
Not yet submitted
Date submitted
10/09/2018
Date registered
19/09/2018
Date last updated
19/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Comparative Feedback via a Mobile Phone Application in improving Recovery post Total Knee Arthroplasty
Scientific title
The Effects of Comparative Feedback via a Mobile Phone Application in improving Recovery post Total Knee Arthroplasty
Secondary ID [1] 296043 0
N/A
Universal Trial Number (UTN)
U1111-1220-1938
Trial acronym
TECMART - The Effects of Comparative feedback via a Mobile phone Application in improving Recovery post Total knee arthroplasty
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 309595 0
Condition category
Condition code
Musculoskeletal 308413 308413 0 0
Osteoarthritis
Mental Health 308414 308414 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, randomised trial comparing effects of comparative feedback vs. individualised feedback in enhancing recovery post total knee replacement .

Patients will be recruited from Hollywood Private Hospital (HPH) in Perth Western Australia with the aim to have multiple surgeons encouraging their patients to participate in the study. We will also encourage hospital staff to take part so the patients can compare their mobility to the average mobility of groups of medical staff. Informed consent for patients will be attained through the app, which will contain a standardised consent form with details regarding the trial. The study will consist of 4 phases:
1) Using a custom developed Apple iPhone iOS based application (app) we aim to monitor an individual’s mobility level through their step count. This component will be exclusively available to all members of staff at HPH, who can download the app onto their iPhones. This phase will run for 30 days and in the analysis stage we will stratify participants into their sub-specialities and asses which specialities are more physically active than others
2) After the first month of trial, we will release the daily step count to the participants, who will be able to see how they performed against other staff groups. We will then monitor mobility levels for the next 30 days, observing any changes. This will enable us to assess the effect of motivation and competition on physical activity. We aim to complete phase 2 by time for submission to the British Medical Journal’s Christmas Edition. This edition is on a more humorous side of research
3) Our app will be provided to 50 patients undergoing TKR at HPH, without any feedback. This phase will serve as a pilot study, with the data collected serving as a baseline for providing feedback to patients that are randomised into the study arm of the trial in Phase 4
4) The same app will be given to at least 120 patients who will be undergoing elective TKR. For the purposes of our study, all enrolled participants will be randomised into the app group with instant feedback or into an app group without any instant feedback, which will be the control group. Participants randomised into the app group with feedback will have access to daily step counts, and comparisons of this against other patients, as well as their treating surgeons and health care professionals (all data will be anonymised and the patients will only see the subtotal scores of the specific population group, e.g. surgeons). They will also have access to average step counts of patients according to the number of days post-operatively. All patients will also be given weekly reminders (alerts) to complete a short app-based questionnaire (Forgotten Joint Score) and pain level (VAS) relating to their recovery and function, and basic psychological outcome measures regarding mood and post-operative satisfaction.

Intervention group - participants in this arm of the trial will receive personalised feedback on their rehab, as well as how they compare against other patients at that stage in post operative recovery (i.e. at day 3 post op, 1 week post op, etc)

1. Participants will be recruited from many different Orthopaedic surgeons, each of whom will have their own little variations to post-operative rehabilitation for their respective patients. As such, the only influence we have if providing feedback on individual performance (for both groups) and overall group feedback (for study cohort).
2.
a. Patients will be given physical/hard-copy versions of an information sheet outline our study. This will be provided during their pre-operative clinic appointment.
b. The procedure being investigated is Total Knee Arthroplasty (replacement)
c. Feedback provided to study group:
i. Daily activity level – step count
ii. Their performance at a particular point in post-operative time vs. other patients at that given time
iii. Their activity level vs. hospital staff (e.g. surgeons, physiotherapists, administrative staff, etc).
iv. Longitudinal (temporal) record of pain and joint range of motion
Feedback given to control group
v. Daily activity level – step count
vi. Longitudinal (temporal) record of pain and joint range of motion
d. Mode of delivery is the Apple iPhone
e. All feedback will be given to patients via the app on their phone. The feedback will continue for up to 1 year post op. Our use of questionnaires will be up until 3 months post op.
f. Location – all patients will be recruited from Hollywood Private Hospital

3. Patients will download our app onto their phone. They will be presented with the study information via the app, and if they consent to partake, they proceed through our app. Patient information sheets will also be given in hard-copy formats to patients when they attend their pre-op clinic appointment
Intervention code [1] 312382 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator group will only receive individualised feedback, without any indication of group progress

Any feedback of this sort (in either patient group) is not part of conventional post total knee arthroplasty care. The study aims to explore the use of this app to enhance patient post operative recover and improve patient outcomes.

Feedback is ADDITIONAL TO USUAL CARE
Control group
Active

Outcomes
Primary outcome [1] 307378 0
Mobility levels (via step count)
Timepoint [1] 307378 0
daily feedback for 1 year post-op
Secondary outcome [1] 351703 0
Forgotten Joint Score - patient satisfaction questionnaire
Timepoint [1] 351703 0
2 weeks post op, 6 weeks post op, 8 weeks post op, 12 weeks post op, 26 weeks post op, 1 year post op
Secondary outcome [2] 351871 0
Visual Analogue Scale - questionnaire for pain
Timepoint [2] 351871 0
2 weeks post op, 6 weeks post op, 8 weeks post op, 12 weeks post op, 26 weeks post op, 1 year post op
Secondary outcome [3] 352012 0
Mood - visual analogue scale
Timepoint [3] 352012 0
2 weeks post op, 6 weeks post op, 8 weeks post op, 12 weeks post op, 26 weeks post op, 1 year post op

Eligibility
Key inclusion criteria
1. Patients undergoing elective primary total knee replacement
2. Patients must be undergoing their surgery at a Ramsay Health Care facility
3. Apple iPhone users (developed software is limited to iOS platform; however, we will explore the possibility of expanding to cater for Android and Windows phone users if the intervention proves effective)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who do not use iOS based Apple smartphones
2. Patients undergoing revision total knee replacement

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment - done via our app
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Via a randomisation table inbuilt into our app
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are aiming 120 patients minimum -> minimum number required for a pilot study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11826 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 23953 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 300632 0
Hospital
Name [1] 300632 0
Hollywood Private Hospital
Country [1] 300632 0
Australia
Primary sponsor type
Hospital
Name
Hollywood Private Hospital
Address
Monash Ave
Nedlands WA 6009
Australia
Country
Australia
Secondary sponsor category [1] 300143 0
None
Name [1] 300143 0
Address [1] 300143 0
Country [1] 300143 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301421 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 301421 0
Monash Ave
Nedlands WA 6009
Australia
Ethics committee country [1] 301421 0
Australia
Date submitted for ethics approval [1] 301421 0
30/09/2018
Approval date [1] 301421 0
Ethics approval number [1] 301421 0

Summary
Brief summary
Our study will explore the effects of comparative feedback in improving post-operative rehab in patients undergoing total knee arthroplasty. This will be done by comparing outcomes in the study group of patients who receive feedback regarding their performance, with comparative feedback regarding the overall groups's. This will be compared to a control group, who only receive individual feedback, and are blinded to the performance of the rest of the group.
Our hypothesis is that comparative feedback motivates patients to improve performance during post operative rehabilitation, thus improving their long term outcomes (e.g. improved joint range of motion, better limb strength, lower pain levels).
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 86938 0
Prof Markus Kuster
Address 86938 0
Perth Orthopaedics and Sports Medicine Centre
31 Outram Street
West Perth WA 6005
Country 86938 0
Australia
Phone 86938 0
+61 0429 004 977
Fax 86938 0
Email 86938 0
[email protected]
Contact person for public queries
Name 86939 0
Dr Senthuren Isaac
Address 86939 0
Orthopaedics Department
Level 1 G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA 6009
Country 86939 0
Australia
Phone 86939 0
+61 0432196979
Fax 86939 0
Email 86939 0
[email protected]
Contact person for scientific queries
Name 86940 0
Dr Senthuren Isaac
Address 86940 0
Orthopaedics Department
Level 1 G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA 6009
Country 86940 0
Australia
Phone 86940 0
+61 0432196979
Fax 86940 0
Email 86940 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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