Remote Monitoring After Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- OMERACT-OARSI responder criteria
研究概览
简要总结
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 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 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.
详细描述
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 or unicondylar (medial) knee replacement surgery due to knee osteoarthritis
Participants are excluded from the study of any of the following criteria apply:
- revision of previous knee replacement surgery
- serious comorbidities (such as severe malignancues, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
- congnitive dysfunction
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The statistician conducting the primary analysis will be blinded to group allocation
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 50 years of age or older
- •Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis
排除标准
- •Revision of previous knee replacement surgery
- •Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)
- •Congitive dysfunction
- •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
研究组 & 干预措施
Control group
Patients randomly allocated to standard follow-up will be summoned for a hospital visit with a physiotherapist at 8 weeks and 12 months post-surgery. The physiotherapist will conduct an 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.
干预措施: Usual Care (Other)
Remote monitoring
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/Dignio 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.
干预措施: Remote monitoring (Other)
结局指标
主要结局
OMERACT-OARSI responder criteria
时间窗: 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
次要结局
- OMERACT-OARSI responder criteria(Baseline, 12 months)
- Healthcare costs(Baseline, 6 and 12 months)
- Health-related quality of life (EQ5D-5L)(Baseline, 6 months, 12 months)
- Safety measures(1 month, 2 months, 3 months, 6 months, 12 months)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 6 months, 12 months)
- Change in pain(Baseline, 2 months, 6 months, 12 months)
- Change in disease activity(Baseline, 2 months, 6 months, 12 months)
- Satisfaction with care(2 months, 6 months, 12 months)
- Satisfaction with total knee replacement surgery(2 months, 6 months, 12 months)
- Change in range of motion(Baseline, 1, 2, 3, 6, 12 months)
- Number of extra visits(Baseline to 12 months)
研究者
Anne Therese Tveter
Professor
Diakonhjemmet Hospital