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| Name | Class |
|---|---|
| National Institute for Health and Disability Insurance, Belgium | OTHER |
| Belgium Health Care Knowledge Centre | OTHER_GOV |
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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).
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Possibility to use the mobile application without a predefined number of physiotherapy sessions | Experimental | 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 | Experimental | Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions |
|
| Usual care | No Intervention | Rehabilitation after hip or knee arthroplasty without the use of a mobile application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moveUp | Device | Mobile application for use in the rehabilitation of primary knee and hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation result 6 months after knee 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. | 6 months after arthroplasty |
| Rehabilitation result 6 months after hip 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. | 6 months after arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation result 6 weeks after knee 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. | 6 weeks after arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Incidents | 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. | baseline until 6 months after arthroplasty |
Eligibility criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Van Der Straeten, Professor | Health, Innovation and Research Institute UZ Ghent | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Antwerp | Belgium | ||||
| Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta |
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| Predefined number of traditional physiotherapy sessions | Other | exercises with a physiotherapist being physically present |
|
| Rehabilitation result 6 weeks after hip 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. | 6 weeks after arthroplasty |
| Quality of life assessment 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. | 6 weeks after arthroplasty |
| Quality of life assessment 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. | 6 months after arthroplasty |
| Sensitivity endpoint KOOS-JR at 6 weeks | 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. | baseline until 6 weeks after arthroplasty |
| Sensitivity endpoint HOOS-JR at 6 weeks | 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. | baseline until 6 weeks after arthroplasty |
| Sensitivity endpoint EQ5D-5L at 6 weeks | 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. | baseline until 6 weeks after arthroplasty |
| Sensitivity endpoint KOOS-JR at 6 months | 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. | baseline until 6 months after arthroplasty |
| Sensitivity endpoint HOOS-JR at 6 months | 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. | baseline until 6 months after arthroplasty |
| Sensitivity endpoint EQ5D-5L at 6 months | 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. | baseline until 6 months after arthroplasty |
| Deaths | anticipated and unanticipated deaths | baseline until 6 months after arthroplasty |
| Auderghem |
| Belgium |
| Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo | Braine-l'Alleud | Belgium |
| AZ Sint-Jan Brugge | Bruges | Belgium |
| AZ Monica Deurne | Deurne | Belgium |
| AZ Alma Eeklo | Eeklo | Belgium |
| AZ Maria Middelares | Ghent | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| Jan Yperman Ziekenhuis | Ieper | Belgium |
| CHU de Liège, site du Sart Tilman | Liège | Belgium |
| AZ Damiaan | Ostend | Belgium |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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