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Trial record 1 of 1 for:    NCT04628468
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Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT04628468
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : June 30, 2021
Sponsor:
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
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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
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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 : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628468


Contacts
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Contact: Hélène De Naeyer, Phd 09/332.05.00 hiruz.ctu@uzgent.be

Locations
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Belgium
Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta Recruiting
Auderghem, Belgium
Contact: Etienne Willemart, MD         
Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo Recruiting
Braine-l'Alleud, Belgium
Contact: Bernard Geulette, MD         
AZ Sint-Jan Brugge Recruiting
Brugge, Belgium
Contact: Maxence Vandekerckhove, MD         
Cliniques Universitaires Saint Luc Not yet recruiting
Brussels, Belgium
Contact: Olivier Cornu, Professor         
Grand Hôpital de Charleroi Not yet recruiting
Charleroi, Belgium
Contact: Hervé Charlier, MD         
AZ Monica Deurne Recruiting
Deurne, Belgium
Contact: Peter Verdonk, MD         
AZ Alma Eeklo Recruiting
Eeklo, Belgium
Contact: Alex Demurie, MD         
AZ Maria Middelares Recruiting
Gent, Belgium
Contact: Pieter Vansintjan, MD         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium
Contact: Jan Victor, Professor         
Jan Yperman Ziekenhuis Recruiting
Ieper, Belgium
Contact: François Hardeman, MD         
CHU de Liège, site du Sart Tilman Recruiting
Liège, Belgium
Contact: William Kurth, MD         
AZ Damiaan Recruiting
Oostende, Belgium
Contact: Thomas De Geest, MD         
Sponsors and Collaborators
University Hospital, Ghent
National Institute for Health and Disability Insurance (NIHDI), Belgium
Belgium Health Care Knowledge Centre
Investigators
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Study Director: Catherine Van Der Straeten, Professor Health, Innovation and Research Institute UZ Ghent
More Information
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04628468    
Other Study ID Numbers: KCE HTA C2020-1
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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