Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000504415
Ethics application status
Approved
Date submitted
15/04/2016
Date registered
19/04/2016
Date last updated
21/10/2021
Date data sharing statement initially provided
18/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TKR Study: Supporting the delivery of total knee replacement care for both patients and their clinicians with a mobile app and online tool.
Scientific title
TKR Study: Investigating the clinical efficacy, economics and satisfaction with a mobile app and online tool to delivery total knee replacement care for both patients and their clinicians.
Secondary ID [1] 289013 0
Nil
Universal Trial Number (UTN)
U1111-1181-9597
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 298424 0
Osteoarthritis 298451 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298519 298519 0 0
Physiotherapy
Musculoskeletal 298552 298552 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises a mobile app, and wearable fitness tracker to support patients with their physical preparation for and recovery from Total Knee Replacement surgery. The app is provided in conjunction with usual care. The app is used for 16 weeks in total, four weeks prior to surgery and 12 weeks after surgery. The fitness tracker is wrist worn and the trial suggests that it is worn 24 hours per day for the 16 week trial, except when charging. No targets or recommendations for activities are set for participants. Participants are given virtual rewards for steps walked. Awards are won the first time a patient walks, 250, 500, 750, 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000 & 10000 steps. Adherence with tracker is used for analysis purposes only.

The TKR app contains information about the TKR procedure as well as hints and tips for surgical preparation, coaching, reminders, video based exercise demonstrations, and visual representations of the data collected through the wearable device. The app is recommended for daily use, to review activity tracking and to complete daily physiotherapy. Participants can use the app as little or as often as they choose. The suggested duration of use is determined by the physiotherapy program set for the individual. In addition to the physiotherapy the participant would spend no more than 1o minutes using the app per day if they interracted with all content and features. Software monitors frequency and duration of use, inclusing use of individual app components.

The care teams for patients in the intervention group will be able to view patient gathered data through the patient portal and configure the exercise programs (i.e. exercise videos) for each patient.
Intervention code [1] 294496 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care from their clinical care team, including the creation of a physiotherapy program for the four weeks leading up to surgery and the 12 weeks after surgery.
Control group
Active

Outcomes
Primary outcome [1] 298015 0
Oxford Knee Score (OKS)
Timepoint [1] 298015 0
4 weeks prior to surgery, 2 days prior to surgery, 12 weeks and 1 year post surgery
Secondary outcome [1] 322902 0
Quality of life using Short-Form Health Survey (SF-36), Version 2
Timepoint [1] 322902 0
4 weeks prior to surgery, 2 days prior to surgery, 12 weeks and 1 year post surgery
Secondary outcome [2] 322903 0
Knee Range of Motion (ROM) assessed by a physiotherapist or surgeon at a routine appointment.
Timepoint [2] 322903 0
4 weeks prior to surgery, 2 days prior to surgery, 12 weeks and 1 year post surgery
Secondary outcome [3] 322904 0
Depression, Anxiety and Stress Scale (DASS21)
Timepoint [3] 322904 0
4 weeks prior to surgery, 2 days prior to surgery, 12 weeks and 1 year post surgery
Secondary outcome [4] 322905 0
Satisfaction with knee surgery and service delivery (composite) using a 5-point Likert scale
Timepoint [4] 322905 0
12 weeks post surgery
Secondary outcome [5] 322906 0
Self-motivation using the self-motivation inventory (SMI)
Timepoint [5] 322906 0
2 days prior to surgery
Secondary outcome [6] 322907 0
self efficacy - adapted version of physical activity self-efficacy scale (SES) (Schwarzer, R., & Renner, B., 2005) designed to ask these questions around rehabilitation exercises rather than general exercise intention. This is a 5-item questionnaire, using 4- point Likert scale.
Timepoint [6] 322907 0
4 weeks prior to surgery, 2 days prior to surgery, 12 weeks and 1 year post surgery
Secondary outcome [7] 322908 0
Economic Impact - informed by patient diary of services used, including direct and indirect costs.
Timepoint [7] 322908 0
12 weeks post surgery
Secondary outcome [8] 332039 0
Satisfaction with technology using a 5-point Likert scale
Timepoint [8] 332039 0
12 weeks post surgery
Secondary outcome [9] 332040 0
Self-determination - 4 question questionnaire

Sheldon KM & Kasser T (1998). Pursuing personal goals: Skills enable progress, but not all progress is beneficial. Personality and Social Psychology Bulletin, 24(12), 1319-1331

It will be tailored for our purposes by referring to being “successful in my knee rehabilitation program”, but otherwise remains in its published form.
Timepoint [9] 332040 0
2 days prior to surgery

Eligibility
Key inclusion criteria
1. Suffering osteoarthritis as the principle diagnosis and reason for TKR.
2. >=50 years and<=80 years under going unilateral total knee replacement for the first time on the planned knee. The average age of osteoarthritis patients undergoing TKR surgery is 68 years, therefore 50 to 80 years is an appropriate range for the study.
3. Be sufficiently healthy to not be adversely affected by participation in the trial.
4. Access to an iOS device (iPhone/iPad) or a leading Android device (smartphone/tablet) with internet connection via mobile internet data or Wi-Fi connection.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous uni-compartmental replacement or tibial osteotomy on the same knee,
2. Previous lower extremity joint replacement surgery within the last 6 months.
3. Major neurologic conditions or cognitive impairment that may result in inability to interact with the smartphone app
4. Uncontrolled diabetes, heart disease, or other medical conditions meaning participation in TKR is non-standard.

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)
Allocation is conducted by research group, located "off-site" only after consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
Initial estimate: 262 patients

Revised estimate (using study data): 100 patients

Revised sample size (with 20% loss) based on smaller SD for within groups and initial SD for correlation among baseline and three repeated measures [80% power, p=0.05, 15% difference].

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/10/2016
Actual
27/10/2016
Date of last participant enrolment
Anticipated
31/05/2019
Actual
30/09/2019
Date of last data collection
Anticipated
31/10/2020
Actual
31/10/2020
Sample size
Target
100
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 293381 0
Commercial sector/Industry
Name [1] 293381 0
Johnson and Johnson Medical Devices AU
Country [1] 293381 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation
Address
Building 101, Clunies Ross Street
Acton ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 292200 0
None
Name [1] 292200 0
None
Address [1] 292200 0
Country [1] 292200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294839 0
CSIRO Health and Medical Research Human Research Ethics Committee (HMR HREC)
Ethics committee address [1] 294839 0
Ethics committee country [1] 294839 0
Australia
Date submitted for ethics approval [1] 294839 0
01/03/2016
Approval date [1] 294839 0
04/04/2016
Ethics approval number [1] 294839 0
1/2016
Ethics committee name [2] 299690 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 299690 0
Ethics committee country [2] 299690 0
Australia
Date submitted for ethics approval [2] 299690 0
01/06/2016
Approval date [2] 299690 0
29/09/2016
Ethics approval number [2] 299690 0
HREC/16/MHS/33

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

Contacts
Principal investigator
Name 65202 0
Dr Jill Freyne
Address 65202 0
CSIRO Health and Biosecurity
GPO Box 76,
Epping,
NSW,
1710
Country 65202 0
Australia
Phone 65202 0
+61293724453
Fax 65202 0
Email 65202 0
[email protected]
Contact person for public queries
Name 65203 0
Ofa Fitzgibbons
Address 65203 0
CSIRO Health and Biosecurity
PO BOX 330
NEWCASTLE
NSW
2300
AUSTRALIA
Country 65203 0
Australia
Phone 65203 0
+61 2 4960 6188
Fax 65203 0
Email 65203 0
[email protected]
Contact person for scientific queries
Name 65204 0
Jill Freyne
Address 65204 0
CSIRO Health and Biosecurity
GPO Box 76,
Epping,
NSW,
1710
Country 65204 0
Australia
Phone 65204 0
+61293724453
Fax 65204 0
Email 65204 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
In accordance with the human ethics approval, participant data will be used for the purpose of this research project, and may be reused for extensions of this project or for general research within CSIRO in the areas of rehabilitation, physiotherapy and orthopaedics with use of mobile application and wearable technology.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5334Study protocolHussain MS, Li J, Brindal E, van Kasteren Y, Varnfield M, Reeson A, Berkovsky S, Freyne J Supporting the Delivery of Total Knee Replacements Care for Both Patients and Their Clinicians With a Mobile App and Web-Based Tool: Randomized Controlled Trial Protocol JMIR Res Protoc 2017;6(3):e32https://www.researchprotocols.org/2017/3/e32/ 



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.