Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Arthroplasty Replacement Knee
- Hip Arthrosis
- Rehabilitation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 manda...
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: The "usual care group" will not be informed about the mobile application and will perform exercises as per standard of care with a physiotherapist during face to face visits. 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 use the mobile application. A predefined number of traditional physiotherapy sessions is combined with the use of the mobile app in this group. 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 use the mobile application. No predefined number of traditional physiotherapy sessions are required. The patient will be asked to complete 3 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. Additionally, a health economic evaluation is foreseen by the Federal Knowledge Center for Healthcare (KCE) in cooperation with the sponsor UZ Ghent. In this way the results can be helpful in getting a more definitive refund for the mobile application in Belgium.
Tracking Information
- NCT #
- NCT04628468
- Collaborators
- National Institute for Health and Disability Insurance (NIHDI), Belgium
- Belgium Health Care Knowledge Centre
- Investigators
- Study Director: Catherine Van Der Straeten, Professor Health, Innovation and Research Institute UZ Ghent