NCT04628468

Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty

Patient Reported Outcome of Rehabilitation and Quality of Life in Computer Literate Patients Undergoing Primary Knee or Hip Arthroplasty and Randomized to Rehabilitation With or Without the Possible Use of a Mobile Application.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty, Replacement, Knee
• Rehabilitation
• Hip Arthrosis

Interventions

Type	Name	Description
DEVICE	moveUp	Mobile application for use in the rehabilitation of primary knee and hip arthroplasty
OTHER	Predefined number of traditional physiotherapy sessions	exercises with a physiotherapist being physically present

Timeline

• Start date: 2021-01-18
• Primary completion: 2023-05-29
• Completion: 2023-05-29
• First posted: 2020-11-13
• Last updated: 2023-07-07

Locations

11 sites across 1 country: Belgium