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

• ClinicalTrials.gov Identifier: NCT04628468
• Recruitment Status: Active, not recruiting
• First Posted: November 13, 2020
• Last Update Posted: October 4, 2022
• Sponsor: University Hospital, Ghent
• Collaborators: National Institute for Health and Disability Insurance (NIHDI), Belgium; Belgium Health Care Knowledge Centre
• Information provided by (Responsible Party): University Hospital, Ghent

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Replacement, Knee; Rehabilitation; Hip Arthrosis	Device: moveUp; Other: Predefined number of traditional physiotherapy sessions	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1011 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: January 18, 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Possibility to use the mobile application without a predefined number of physiotherapy sessions; Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.	Device: moveUp; Mobile application for use in the rehabilitation of primary knee and hip arthroplasty
Experimental: Possibility to use the mobile application with a predefined number of physiotherapy sessions; Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions	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
No Intervention: Usual care; Rehabilitation after hip or knee arthroplasty without the use of a mobile application.

Outcome Measures

Primary Outcome Measures :

1. Rehabilitation result 6 months after knee arthroplasty [ Time Frame: 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.
2. Rehabilitation result 6 months after hip arthroplasty [ Time Frame: 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.

Secondary Outcome Measures :

1. Rehabilitation result 6 weeks after knee arthroplasty [ Time Frame: 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.
2. Rehabilitation result 6 weeks after hip arthroplasty [ Time Frame: 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.
3. Quality of life assessment 6 weeks after arthroplasty [ Time Frame: 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.
4. Quality of life assessment 6 months after arthroplasty [ Time Frame: 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.

Other Outcome Measures:

1. Incidents [ Time Frame: baseline until 6 months after arthroplasty ]
   Any malfunction or deterioration in the characteristics and/or performance of the medical device app, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
2. Sensitivity endpoint KOOS-JR at 6 weeks [ Time Frame: baseline until 6 weeks after arthroplasty ]
   Change in KOOS-JR score from baseline at 6 weeks after arthroplasty. KOOS-JR is a Knee injury and Osteoarthritis Outcome Score for Joint Replacement. 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.
3. Sensitivity endpoint HOOS-JR at 6 weeks [ Time Frame: baseline until 6 weeks after arthroplasty ]
   change in HOOS-JR score from baseline at 6 weeks after arthroplasty. HOOS-JR is a Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement. 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.
4. Sensitivity endpoint EQ5D-5L at 6 weeks [ Time Frame: baseline until 6 weeks after arthroplasty ]
   change in EQ5D-5L score from baseline at 6 weeks after arthroplasty. 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.
5. Sensitivity endpoint KOOS-JR at 6 months [ Time Frame: baseline until 6 months after arthroplasty ]
   Change in KOOS-JR score from baseline at 6 months after arthroplasty. KOOS-JR is aKnee injury and Osteoarthritis Outcome Score for Joint Replacement. 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.
6. Sensitivity endpoint HOOS-JR at 6 months [ Time Frame: baseline until 6 months after arthroplasty ]
   Change in HOOS-JR score from baseline at 6 months after arthroplasty. HOOS-JR is a Hip dysfunction and Osteoarthritis Outcome score for Joint Replacement. 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.
7. Sensitivity endpoint EQ5D-5L at 6 months [ Time Frame: baseline until 6 months after arthroplasty ]
   change in EQ5D-5L score from baseline at 6 months after arthroplasty. 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.
8. Deaths [ Time Frame: baseline until 6 months after arthroplasty ]
   anticipated and unanticipated deaths

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Eligibility criteria:

1. The patient is aged 18 years or older, has a Belgian National Number, is insured by a Belgian sickness fund, and is not staying in a nursing home or long term rehabilitation centre.
2. The patient has sufficient knowledge of Dutch, French, German or English.
3. The patient has a planned date between the next 1 to 8 weeks for a primary unilateral unicompartmental knee arthroplasty (UKA); a bicompartmental knee arthroplasty, (BKA), consisting of either two UKA or a UKA and a patellar replacement; or a total knee arthroplasty (TKA) or a total hip arthroplasty (THA).
4. The patient is not planned to have a peri-operative procedure (e.g. intra-articular catheter) or postoperative procedure that is expected to significantly impact the rehabilitation in and out of hospital.
5. In the 6 months after arthroplasty the patient is not planned to have surgery that may impact the arthroplasty rehabilitation.
6. The patient is not suffering from a medical condition (e.g. Parkinson, multiple sclerosis, cerebrovascular accident) that is expected to significantly impact the rehabilitation or that constitutes a contra-indication for the use of the mobile application.
7. The patient confirms to have easy and daily access to the internet, a mobile phone, a personal email address and a computer, tablet or smartphone, until 8 months after randomization.
8. The patient does not upfront exclude the possibility whereby part of the rehabilitation is performed without a physical therapist physically being present.
9. The patient is willing to complete online the patient reported outcomes and is aware that if he/she fails in this computer literacy test (performed before randomization) he/she will not be randomized and hence not included in the study. He/she will receive usual rehabilitation care.

Contacts and Locations

Locations

Belgium

Antwerp University Hospital

Antwerp, Belgium

Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta

Auderghem, Belgium

Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo

Braine-l'Alleud, Belgium

AZ Sint-Jan Brugge

Brugge, Belgium

AZ Monica Deurne

Deurne, Belgium

AZ Alma Eeklo

Eeklo, Belgium

AZ Maria Middelares

Gent, Belgium

Universitair Ziekenhuis Gent

Gent, Belgium

Jan Yperman Ziekenhuis

Ieper, Belgium

CHU de Liège, site du Sart Tilman

Liège, Belgium

AZ Damiaan

Oostende, Belgium

Sponsors and Collaborators

University Hospital, Ghent

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

More Information

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04628468
• Other Study ID Numbers: KCE HTA C2020-1
• First Posted: November 13, 2020
• Last Update Posted: October 4, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Ghent:

mobile application; patient reported outcomes, PROMs; physiotherapy; telerehabilitation

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases