Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 1:22 AM
Study NCT ID:
NCT04628468
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidents', 'timeFrame': 'baseline until 6 months after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint KOOS-JR at 6 weeks', 'timeFrame': 'baseline until 6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint HOOS-JR at 6 weeks', 'timeFrame': 'baseline until 6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint EQ5D-5L at 6 weeks', 'timeFrame': 'baseline until 6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint KOOS-JR at 6 months', 'timeFrame': 'baseline until 6 months after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint HOOS-JR at 6 months', 'timeFrame': 'baseline until 6 months after arthroplasty', 'description': '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.'}, {'measure': 'Sensitivity endpoint EQ5D-5L at 6 months', 'timeFrame': 'baseline until 6 months after arthroplasty', 'description': '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.'}, {'measure': 'Deaths', 'timeFrame': 'baseline until 6 months after arthroplasty', 'description': 'anticipated and unanticipated deaths'}], 'primaryOutcomes': [{'measure': 'Rehabilitation result 6 months after knee arthroplasty', 'timeFrame': '6 months after arthroplasty', 'description': '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.'}, {'measure': 'Rehabilitation result 6 months after hip arthroplasty', 'timeFrame': '6 months after arthroplasty', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rehabilitation result 6 weeks after knee arthroplasty', 'timeFrame': '6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Rehabilitation result 6 weeks after hip arthroplasty', 'timeFrame': '6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Quality of life assessment 6 weeks after arthroplasty', 'timeFrame': '6 weeks after arthroplasty', 'description': '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.'}, {'measure': 'Quality of life assessment 6 months after arthroplasty', 'timeFrame': '6 months after arthroplasty', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile application', 'patient reported outcomes, PROMs', 'physiotherapy', 'telerehabilitation'], 'conditions': ['Arthroplasty, Replacement, Knee', 'Rehabilitation', 'Hip Arthrosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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).', 'detailedDescription': '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.\n\nEligible patients will be randomized to one of the three treatment options of the study:\n\n1. 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.\n2. 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.\n3. 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.\n\nThe 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility criteria:\n\n1. 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.\n2. The patient has sufficient knowledge of Dutch, French, German or English.\n3. 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).\n4. 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.\n5. In the 6 months after arthroplasty the patient is not planned to have surgery that may impact the arthroplasty rehabilitation.\n6. 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.\n7. 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.\n8. The patient does not upfront exclude the possibility whereby part of the rehabilitation is performed without a physical therapist physically being present.\n9. 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.'}, 'identificationModule': {'nctId': 'NCT04628468', 'briefTitle': 'Patient Reported Outcome Measures (PROMs) in Rehabilitation With or Without the Possible Use of a Mobile Application After Primary Knee or Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'KCE HTA C2020-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Possibility to use the mobile application without a predefined number of physiotherapy sessions', 'description': 'Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.', 'interventionNames': ['Device: moveUp']}, {'type': 'EXPERIMENTAL', 'label': 'Possibility to use the mobile application with a predefined number of physiotherapy sessions', 'description': 'Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions', 'interventionNames': ['Device: moveUp', 'Other: Predefined number of traditional physiotherapy sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Rehabilitation after hip or knee arthroplasty without the use of a mobile application.'}], 'interventions': [{'name': 'moveUp', 'type': 'DEVICE', 'description': 'Mobile application for use in the rehabilitation of primary knee and hip arthroplasty', 'armGroupLabels': ['Possibility to use the mobile application with a predefined number of physiotherapy sessions', 'Possibility to use the mobile application without a predefined number of physiotherapy sessions']}, {'name': 'Predefined number of traditional physiotherapy sessions', 'type': 'OTHER', 'description': 'exercises with a physiotherapist being physically present', 'armGroupLabels': ['Possibility to use the mobile application with a predefined number of physiotherapy sessions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Auderghem', 'country': 'Belgium', 'facility': 'Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta', 'geoPoint': {'lat': 50.81667, 'lon': 4.43333}}, {'city': "Braine-l'Alleud", 'country': 'Belgium', 'facility': "Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo", 'geoPoint': {'lat': 50.68363, 'lon': 4.36784}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Deurne', 'country': 'Belgium', 'facility': 'AZ Monica Deurne', 'geoPoint': {'lat': 51.22134, 'lon': 4.46595}}, {'city': 'Eeklo', 'country': 'Belgium', 'facility': 'AZ Alma Eeklo', 'geoPoint': {'lat': 51.18703, 'lon': 3.55654}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Ieper', 'country': 'Belgium', 'facility': 'Jan Yperman Ziekenhuis', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège, site du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Ostend', 'country': 'Belgium', 'facility': 'AZ Damiaan', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}], 'overallOfficials': [{'name': 'Catherine Van Der Straeten, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Health, Innovation and Research Institute UZ Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health and Disability Insurance (NIHDI), Belgium', 'class': 'UNKNOWN'}, {'name': 'Belgium Health Care Knowledge Centre', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}