Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001067965
Ethics application status
Approved
Date submitted
9/07/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mobile Technology to Assist Patient Education and Research in Arthroplasty
Scientific title
Mobile Technology to Assist Patient Education and Research in Arthroplasty
Secondary ID [1] 301710 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 318163 0
Total Hip Replacement 318164 0
Condition category
Condition code
Musculoskeletal 316181 316181 0 0
Osteoarthritis
Musculoskeletal 316661 316661 0 0
Other muscular and skeletal disorders
Surgery 316662 316662 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients receive the POP app irrespective if they are enrolled in the study, as it is a part of standard of care practices following total hip arthroplasty (THA) procedures. The purpose of this observational study is to observe the clinical utility of the app in delivering standard post-operative treatment program, satisfaction questionnaires and rehabilitation instructions. The Patient Optimised Pathway (POP) App is a mobile phone application which delivers information on post-operative treatment program, rehabilitation and research tools for patients undergoing total hip or knee replacement. Patients fill out Patient Reported Outcome Measures (PROMs) surveys and Patient Satisfaction surveys delivered via the app at Baseline (1-4 weeks pre-surgery), Day 1 post-surgery, 2 weeks post-surgery, 6 weeks post-surgery, 3 months post-surgery and 6 months post-surgery. The duration of the app use is at the participants discretion.
Intervention code [1] 318017 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324367 0
Patient satisfaction with the mobile phone application ("app") in delivering information on their treatment program, rehabilitation and research tools.
This is assessed by patient completion of study-specific patient satisfaction survey delivered via the app.
Timepoint [1] 324367 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [1] 384460 0
Changes over time (pre and post-surgery) in Oxford Hip Questionnaire Scores
Timepoint [1] 384460 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [2] 384461 0
Average scores obtained in Risk Assessment Prediction Tool (RAPT). This is a patient score calculated to determine the the level of acute care and rehabilitation required post-surgery.
Timepoint [2] 384461 0
Baseline (pre-surgery)
Secondary outcome [3] 384462 0
Changes over time (pre and post surgery) in Oxford Knee Questionnaire Scores
Timepoint [3] 384462 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [4] 384463 0
EQ-5D - EQ-5D is a validated survey that measures quality of life.
Timepoint [4] 384463 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [5] 384464 0
Knee and Osteoarthritis Outcome Score (KOOS)
Timepoint [5] 384464 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [6] 386616 0
Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [6] 386616 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [7] 386617 0
Multi-attribute Arthritis Prioritisation Tool (MAPT),
Timepoint [7] 386617 0
Baseline (pre-surgery), Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-surgery.

Eligibility
Key inclusion criteria
- Patients 18 years or over presenting with hip or knee arthritis that meets the indications for hip or knee arthroplasty respectively
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery
- Patients who are considered by the surgeon to be capable of following the patient optimised pathway
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients under the age of 18 years
- Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study
- Any patient who cannot or will not provide informed consent for participation in the study
- Patients who need revision surgery
- Patients unable to communicate in English
- Any case not described in the inclusion criteria
- Patients who do not own a compatible smartphone

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All patients receive the POP device app as part of standard of care practices for under going Total Hip Arthroplasty procedures, irrespective if they are enrolled in the study.
This is a pilot, observation study designed to assess the acceptability of the application, with no comparator group. As such, it is not powered to demonstrate any statistically significant differences. All the collected categorical variables will be reported by frequency distribution, percentage and confidence interval. The quantitative variable will be reported as mean, standard deviation, minimum and maximum. No comparative data will be required as this is a pilot study with no control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2020
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
30
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30705 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 306145 0
Commercial sector/Industry
Name [1] 306145 0
Medacta Australia
Country [1] 306145 0
Australia
Funding source category [2] 306154 0
University
Name [2] 306154 0
University of the Sunshine Coast Clinical Trials
Country [2] 306154 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia
Address
Unita A1, 16 Mars Road
Lane Cove NSW 2066
Country
Australia
Secondary sponsor category [1] 306615 0
University
Name [1] 306615 0
University of the Sunshine Coast Clinical Trials
Address [1] 306615 0
Level 1, 9 Ochre Way
Sippy Downs QLD 4556
Country [1] 306615 0
Australia
Other collaborator category [1] 281381 0
Other
Name [1] 281381 0
Sunshine Coast Orthopaedic Group
Address [1] 281381 0
Suite 12, 3 Doherty Street
Birtinya QLD 4575
Country [1] 281381 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306365 0
Bellberry Limited
Ethics committee address [1] 306365 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 306365 0
Australia
Date submitted for ethics approval [1] 306365 0
04/12/2019
Approval date [1] 306365 0
20/02/2020
Ethics approval number [1] 306365 0
2019-12-1086

Summary
Brief summary
All patients receive the POP device app as part of standard of care practices for under going Total Hip Arthroplasty procedures, irrespective if they are enrolled in the study. This is is a pilot, observational, prospective study to assess patient satisfaction of a mobile phone application (App) as a means of delivering information on post-operative treatment program, rehabilitation and research tools for patients undergoing total hip or knee replacement.
Follow up of Patient Reported Outcome Measures (PROMs) is essential to auditing practice and undertaking research in arthroplasty. Traditionally, PROM data is collected via paperwork. Similarly, patient education about post-operative regimens has been in the form of verbal discussions and multiple sheets of paper. The Patient Optimised Pathway application (POP-App) has been designed to reduce this paperwork burden. It is hoped this app will improve the surgical patient journey.
30 participants will be enrolled into a single arm of the study (no control group). Participants will be shown how to use the app and fill out the PROMs prior to operation. They will then be asked to fill out PROMs and Patient Satisfaction surveys pre-operatively and at Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-operatively.
Data collected will confirm acceptability of the app.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103622 0
Dr Daevyd Rodda
Address 103622 0
Sunshine Coast Orthopaedic Group
Suite 12, 3 Doherty Street
Birtinya QLD 4575
Country 103622 0
Australia
Phone 103622 0
+61 7 54938038
Fax 103622 0
Email 103622 0
[email protected]
Contact person for public queries
Name 103623 0
Dr Daevyd Rodda
Address 103623 0
Sunshine Coast Orthopaedic Group
Suite 12, 3 Doherty Street
Birtinya QLD 4575
Country 103623 0
Australia
Phone 103623 0
+61 7 54938038
Fax 103623 0
Email 103623 0
[email protected]
Contact person for scientific queries
Name 103624 0
Dr Daevyd Rodda
Address 103624 0
Sunshine Coast Orthopaedic Group
Suite 12, 3 Doherty Street
Birtinya QLD 4575
Country 103624 0
Australia
Phone 103624 0
+61 7 54938038
Fax 103624 0
Email 103624 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
The objective is to compile and statistically analyse the data and then present findings at a national scientific forum and/or publish findings in a peer-reviewed journal.


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.