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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

Primary Purpose

Arthroplasty, Replacement, Knee, Rehabilitation, Hip Arthrosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
moveUp
Predefined number of traditional physiotherapy sessions
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring mobile application, patient reported outcomes, PROMs, physiotherapy, telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Antwerp University Hospital
  • Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta
  • Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo
  • AZ Sint-Jan Brugge
  • AZ Monica Deurne
  • AZ Alma Eeklo
  • AZ Maria Middelares
  • Universitair Ziekenhuis Gent
  • Jan Yperman Ziekenhuis
  • CHU de Liège, site du Sart Tilman
  • AZ Damiaan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Possibility to use the mobile application without a predefined number of physiotherapy sessions

Possibility to use the mobile application with a predefined number of physiotherapy sessions

Usual care

Arm Description

Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.

Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions

Rehabilitation after hip or knee arthroplasty without the use of a mobile application.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 27, 2020
Last Updated
July 6, 2023
Sponsor
University Hospital, Ghent
Collaborators
National Institute for Health and Disability Insurance (NIHDI), Belgium, Belgium Health Care Knowledge Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04628468
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
May 29, 2023 (Actual)
Study Completion Date
May 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
National Institute for Health and Disability Insurance (NIHDI), Belgium, Belgium Health Care Knowledge Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Rehabilitation, Hip Arthrosis
Keywords
mobile application, patient reported outcomes, PROMs, physiotherapy, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Possibility to use the mobile application without a predefined number of physiotherapy sessions
Arm Type
Experimental
Arm Description
Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and no predefined traditional physiotherapy.
Arm Title
Possibility to use the mobile application with a predefined number of physiotherapy sessions
Arm Type
Experimental
Arm Description
Rehabilitation after hip or knee arthroplasty with the option to use a mobile application and a predefined number of traditional physiotherapy sessions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Rehabilitation after hip or knee arthroplasty without the use of a mobile application.
Intervention Type
Device
Intervention Name(s)
moveUp
Intervention Description
Mobile application for use in the rehabilitation of primary knee and hip arthroplasty
Intervention Type
Other
Intervention Name(s)
Predefined number of traditional physiotherapy sessions
Intervention Description
exercises with a physiotherapist being physically present
Primary Outcome Measure Information:
Title
Rehabilitation result 6 months after knee 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.
Time Frame
6 months after arthroplasty
Title
Rehabilitation result 6 months after hip 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.
Time Frame
6 months after arthroplasty
Secondary Outcome Measure Information:
Title
Rehabilitation result 6 weeks after knee 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.
Time Frame
6 weeks after arthroplasty
Title
Rehabilitation result 6 weeks after hip 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.
Time Frame
6 weeks after arthroplasty
Title
Quality of life assessment 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.
Time Frame
6 weeks after arthroplasty
Title
Quality of life assessment 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.
Time Frame
6 months after arthroplasty
Other Pre-specified Outcome Measures:
Title
Incidents
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.
Time Frame
baseline until 6 months after arthroplasty
Title
Sensitivity endpoint KOOS-JR at 6 weeks
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.
Time Frame
baseline until 6 weeks after arthroplasty
Title
Sensitivity endpoint HOOS-JR at 6 weeks
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.
Time Frame
baseline until 6 weeks after arthroplasty
Title
Sensitivity endpoint EQ5D-5L at 6 weeks
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.
Time Frame
baseline until 6 weeks after arthroplasty
Title
Sensitivity endpoint KOOS-JR at 6 months
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.
Time Frame
baseline until 6 months after arthroplasty
Title
Sensitivity endpoint HOOS-JR at 6 months
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.
Time Frame
baseline until 6 months after arthroplasty
Title
Sensitivity endpoint EQ5D-5L at 6 months
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.
Time Frame
baseline until 6 months after arthroplasty
Title
Deaths
Description
anticipated and unanticipated deaths
Time Frame
baseline until 6 months after arthroplasty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility criteria: 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. The patient has sufficient knowledge of Dutch, French, German or English. 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). 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. In the 6 months after arthroplasty the patient is not planned to have surgery that may impact the arthroplasty rehabilitation. 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. 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. The patient does not upfront exclude the possibility whereby part of the rehabilitation is performed without a physical therapist physically being present. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Van Der Straeten, Professor
Organizational Affiliation
Health, Innovation and Research Institute UZ Ghent
Official's Role
Study Director
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
Country
Belgium
Facility Name
Centre Hospitalier Interrégional Edith Cavell (CHIREC), site Delta
City
Auderghem
Country
Belgium
Facility Name
Centre Hospitalier Interrégional Edith Cavell (CHIREC), Hôpital de Braine L'Alleud-Waterloo
City
Braine-l'Alleud
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
Country
Belgium
Facility Name
AZ Monica Deurne
City
Deurne
Country
Belgium
Facility Name
AZ Alma Eeklo
City
Eeklo
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
Jan Yperman Ziekenhuis
City
Ieper
Country
Belgium
Facility Name
CHU de Liège, site du Sart Tilman
City
Liège
Country
Belgium
Facility Name
AZ Damiaan
City
Oostende
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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