Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty
- Conditions
- RehabilitationHip ArthrosisArthroplasty, Replacement, Knee
- Interventions
- Device: moveUpOther: Predefined number of traditional physiotherapy sessions
- Registration Number
- NCT04628468
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Rehabilitation after primary knee or hip arthroplasty may include performing exercises with a physiotherapist. For patients who can work well with a computer, tablet or smartphone, it is now possible to use a mobile application (e.g. moveUp) to carry out a large part of the exercises more independently. This is done with online guidance by a physiotherapist via a mobile application that is CE marked in Europe.
This study will investigate whether the effect of the mobile application on knee or hip rehabilitation and quality of life is equal to that of standard care (i.e. without the use of a mobile application).
- Detailed Description
Via the moveUP Coach App, patients receive personalized rehabilitation for knee or hip replacement, both before and after surgery. This mobile application is on the market, meets the legal requirements in Europe and has been provisionally remunerated under an agreement (convention) between the mandatory health insurance (NIHDI) and the hospital that participate in this study.
Eligible patients will be randomized to one of the three treatment options of the study:
1. The "usual care group" will not be informed in detail about the mobile application and will receive usual rehabilitation care for knee- or hip replacement.
2. The group "possibility to use the mobile application with a predefined number of physiotherapy sessions" will receive all necessary information on the mobile application and can still decide whether or not to receive rehabilitation with online guidance by a physiotherapist via the mobile application. A predefined number of traditional physiotherapy sessions is combined with the use of the mobile app in this group.
3. The group "possibility to use the mobile application without a predetermined number of physiotherapy sessions" will receive all necessary information on the mobile application and can still decide whether or not to receive rehabilitation with online guidance by a physiotherapist via the mobile application. No predefined number of traditional physiotherapy sessions are required.
The patient will be asked to complete 2 questionnaires (KOOS-JR/HOOS-JR and EQ5D-5L) at baseline, 6 weeks and 6 months after arthroplasty. These patient reported outcomes will give an indication on the rehabilitation outcome and quality of life compared in the 3 groups.
At the end of the study, a health economic evaluation is foreseen by the Federal Knowledge Center for Healthcare (KCE). In this way the results can be helpful in getting a more definitive refund for the mobile application in Belgium.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Possibility to use the mobile application with a predefined number of physiotherapy sessions moveUp Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions Possibility to use the mobile application without a predefined number of physiotherapy sessions moveUp Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy. Possibility to use the mobile application with a predefined number of physiotherapy sessions Predefined number of traditional physiotherapy sessions Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions
- Primary Outcome Measures
Name Time Method Rehabilitation result 6 months after hip arthroplasty 6 months after arthroplasty Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement (HOOS-JR score). HOOS-JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Rehabilitation result 6 months after knee arthroplasty 6 months after arthroplasty Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR score). KOOS-JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
- Secondary Outcome Measures
Name Time Method Rehabilitation result 6 weeks after knee arthroplasty 6 weeks after arthroplasty Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR score). KOOS-JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Quality of life assessment 6 weeks after arthroplasty 6 weeks after arthroplasty EQ5D-5L score. This score describes and values health-related quality of life and consist (1) the EQ-5D descriptive system with 5 dimensions each having 5 response levels from 1 indicating no problems to 5 indicating extreme problems, and (2) the EQ visual analogue scale (EQ VAS), a 0-100 scale with 0 score the worst health the patient can imagine and 100 the best health the patient can imagine.
Quality of life assessment 6 months after arthroplasty 6 months after arthroplasty EQ5D-5L score. This score describes and values health-related quality of life and consist (1) the EQ-5D descriptive system with 5 dimensions each having 5 response levels from 1 indicating no problems to 5 indicating extreme problems, and (2) the EQ visual analogue scale (EQ VAS), a 0-100 scale with 0 score the worst health the patient can imagine and 100 the best health the patient can imagine.
Rehabilitation result 6 weeks after hip arthroplasty 6 weeks after arthroplasty Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement (HOOS-JR score). HOOS-JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Trial Locations
- Locations (11)
Antwerp University Hospital
🇧🇪Antwerp, Belgium
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
AZ Monica Deurne
🇧🇪Deurne, Belgium
Jan Yperman Ziekenhuis
🇧🇪Ieper, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
AZ Alma Eeklo
🇧🇪Eeklo, Belgium
Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta
🇧🇪Auderghem, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo
🇧🇪Braine-l'Alleud, Belgium
CHU de Liège, site du Sart Tilman
🇧🇪Liège, Belgium