Remote Monitoring After Total Knee Replacement
- Conditions
- Knee Arthroplasty, Total
- Registration Number
- NCT07003932
- Lead Sponsor
- Diakonhjemmet Hospital
- Brief Summary
The goal of this clinical trial is to evaluate the effect, cost-effectiveness, safety and satisfaction with replacing standardized, pre-scheduled face-to-face visits with remote monitoring and video consultations or face-to-face consultations only when needed after total knee replacement surgery due to knee osteoarthritis.
The primary outcome is the probability of being a OMERACT-OARSI responder at 6 months post-surgery. This is a composite index where participants are classified as a responder or non-responder based on improvement in pain, function and/or disease activity. Health-related quality of life and healthcare costs will be used to determine cost-effectiveness. Patient-reported adverse events and statisfaction will be used to determine safety and satisfaction.
Patients will be recruited from Diakonhjemmet Hospital. Patients undergoing total knee replacement surgery will be randomly allocated to a control group who are summoned for a face-to-face consultation at Diakonhjemmet Hospital at 2 and 12 months, or a remote monitoring group who will not be scheduled for hospital visits but will answer patient-reported outcomes throught a web-application at 1, 2, 3, 6 and 12 months post-surgery and only be scheduled for hospital visits when needed.
An additional study with follow-up after 5 and 10 years will be conducted.
- Detailed Description
Participants are eligible for inclusion in the study if the following criteria apply:
* men and women, 50 years of age or older
* referred to total knee replacement surgery due to knee osteoarthritis
Participants are excluded from the study of any of the following criteria apply:
* revision of previous total knee replacement surgery
* serious comorbidities (such as severe malignancues, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
* congnitive dysfunction
* total knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)
* unable to understand Norwegian
* Cannot answer questionnaires digitally (lack BankID, do not possess a smartphone
* deemed inappropriate for remote monitoring by orthopedic surgeon
Patients included in both treatment arms will receive medical treatment according to current treatment recommendations as applied by the treating orthopedic surgeon after total knee replacement. All partients are recommended to seek physiotherapy treatment in primary care after surgery
Patients randomly allocated to the control group will be summoned for a hospital visit with a physiotherapist at 2 and 12 months. The physiotherapist will conduct assessment in line with regular clinical practice. If the patient is experiencing lack of improvement or adverse events, an orthopedic surgeon may be consulted. The patients will also answer patient-reported outcomes at 8 weeks and 6- and 12 months post-surgery, however, these answers will not be monitored.
Patients randomly allocated to the remote monitoring group will answer patient-reported outcome at 1, 2, 3, 6 and 12 months. They will be provided with a brief introduction from the study personnel on how to answer questions remotely through the Youwell platform. Patients will get an SMS notification on their mobile phone with a link to the questionnaire. They will have to log in with BankID to access the questionnaire. A physiotherapist will monitor the answers and will contact the patient if an unexpected deterioration or adverse events are detected.
Data will be collected through Nettskjema or the Youwell software program and will be stored in Services for Sensitive Data (TSD) and a a secure server at Diakonhjemmet Hospital.
The following data will be recorded through self-report in the baseline questionnaire:
* Demography: mobile number, education, work status, living arrangement, socioeconomic status, social support, expectations about treatment, fear of movement, catastrophizing, self-efficacy
* Disease variables: KOOS, other joints with osteoarthritis, duration of complaint, previous treatment, fatigue, disease activity, pain, function, pain medication, osteoarthritis quality indicators, knee flexion/extension, use of walking aids
* Lifestyle variables: physical activity, motivation for exercise, motivation for surgery
* Health competency, digital self-efficacy
* Patient satisfaction
* Health-related quality of life The following information will be collected from medical records
* Demographic variables: Age, gender, height, weight, comorbidity, referred knee, smoking,
* General medical history: description of radiographs, type of scheduled arthroplasty, joint status prior to surgery
Patients allocated to the remote monitoring group will receive an SMS with link to questionnaires in the Youwell platform at 1, 2, 3, 6 and 12 months. The following data will be collected for the remote monitoring group:
* Global rating of change
* Pain/Pain medication
* Fear of movement
* Expectations about treatment
* Disease activity
* Signs inflammation/swelling
* Function/activity
* Knee flexion/extension
* Use of walking aids
* Exercise
* Contact with physiotherapist/ rehabilitation stay
* Adverse events
* Patient satisfaction with care
A highly experienced physiotherapist will review the answers and based on these make a clinical judgement whether there is a need to call the patient or summon the patient for a physical examination, or if the patient seems to manage well at home.
Patients in the control group will also answer the remote monitoring questionnaire at 2 months, however, their answers will not be monitored (just for research purposes).
At follow-up, the following variables will be collected:
* Global rating of change
* Disease variables: KOOS, fatigue, disease activity, pain, function, pain medication,
* Fear of movement
* Self-efficacy
* Knee flexion/extension
* Lifestyle variables: physical activity,
* Patient satisfaction with care
* Health-related quality of life
* Health care costs: hospital stay, rehabilitation stay, travel distance to hospital, transportation, health care use
* Adverse events
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Men and women, 50 years of age or older
- Reffered to total knee replacement surgery due to knee osteoarthritis
- Revision of previous total knee replacement surgery
- Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
- Congitive dysfunction
- Total knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)
- Unable to understand Norwegian
- Low digital competency/ cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)
- Deemed inappropriate for remote monitoring by orthopedic surgeon
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method OMERACT-OARSI responder criteria Baseline, 6 months The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria:
High improvement on pain or function
* ≥50% improvement + absolute change of ≥2 points in pain, OR
* ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following
* ≥20% improvement + absolute change of ≥1 point in pain
* ≥20% improvement + absolute change of ≥1 point in function
* ≥20% improvement + absolute change of ≥1 point in disease activity
- Secondary Outcome Measures
Name Time Method Satisfaction with care 2 months, 6 months, 12 months Measured on a numeric rating scale (0-10) with higher score indicating higher satisfaction with care.
Change in disease activity Baseline, 2 months, 6 months, 12 months Measured on a numeric rating scale (0-10) with 10 indicating worst disease activity.
OMERACT-OARSI responder criteria Baseline, 12 months The OMERACT-OARSI responder criteria is a composite index where participants are classifies as responders or non-responders (binary outcome) based on the following criteria: High improvement on pain or function • ≥50% improvement + absolute change of ≥2 points in pain, OR • ≥50% improvement + absolute change of ≥2 point on KOOS) OR Improvement in at least two of the three following • ≥20% improvement + absolute change of ≥1 point in pain • ≥20% improvement + absolute change of ≥1 point in function • ≥20% improvement + absolute change of ≥1 point in disease activity
Healthcare costs Baseline, 6 and 12 months Direct (consultations in primary or specialist healthcare) and indirect costs (sick leave, medication, travel costs) collected from national registers (NAV, KUHR, NPR) or self-report. Summed up to cost per patient (euro).
Health-related quality of life (EQ5D-5L) Baseline, 6 months, 12 months 5 dimensions rated on a 5-point Likert scale, calculated utility score between 0 and 1 (best health)
Safety measures 1 month, 2 months, 3 months, 6 months, 12 months Any adverse events during the follow-up period. Any contact with hospital, emergency unit and general practitioned due to acute worsening. 1 and 3 months only for the remote monitoring group
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Baseline, 6 months, 12 months Assessment of three dimentions of the KOOS (pain, activity in daily living and health-related quality of life) summed up to 0-100 scales where 100 is best score.
Change in pain Baseline, 2 months, 6 months, 12 months Measured on numeric rating scales (0-10) with higher score indicating more pain
Satisfaction with total knee replacement surgery 2 months, 6 months, 12 months Assessed using 4 primary questions, each rated on a 5-point Likert scale (from "very satisfied" to "very dissatisfied"), and a question about change in health-related quality of life rated on a 6-point scale (from "more improvement than I ever dreamed about" to "the quality of my life is worse")
Change in range of motion Baseline, 1, 2, 3, 6, 12 months Knee flexion and extension is self-reported based on pictures of different degrees of range of motion. Measurement at 1 and 3 months only for the remote monitoring group.
Number of extra visits Baseline to 12 months Number of extra visits in both groups
Trial Locations
- Locations (1)
Diakonhjemmet Hospital
🇳🇴Oslo, Please Select, Norway