Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Physical functioning
研究概览
简要总结
This study will compare the effects of a novel web-based program (Joint Academy) to regular face-to-face treatment (the BOA program) for people with osteoarthritis of the knee. Half of the participants will be randomized to the web-based program whilst the other half will receive regular face-to-face care.
详细描述
According to national and international guidelines, osteoarthritis (OA) treatment consists of exercise and information. The face-to-face BOA program is a model to deliver this treatment at primary care facilities in Sweden. Presently less than 20% of people with OA receive adequate treatment. This may be due to lack of healthcare resources or people having trouble to fit their schedule to primary care opening hours. To facilitate a better OA care, alternative methods are therefore required.
A two-armed randomized clinical superiority trial will be performed to compare OA treatment by a web-based program, Joint Academy, with the traditional face-to-face BOA program in 270 adults with clinically verified OA. Using intention-to-treat analysis and per-protocol, evaluations will be performed at baseline, after 6 weeks and after 3, 6 and 12 months. The primary outcome is physical function. Secondary outcomes are joint pain, health-related quality of life, self-reported function, amount of time of physical activity/exercise and overall satisfaction. A health-economic analysis will also be performed. The primary endpoint will be at 12 months. Data will be monitored using web-based questionnaires in Joint Academy, and regular paper questionnaires for the face-to-face treatment.
Should the trial show superiority in favor of Joint Academy, an implementation of the web-based treatment would benefit both patient and society at large, since Joint Academy entails a more flexible treatment in regards to time and location, and is not as costly per-patient as regular face-to-face treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I: A clinical diagnosis of knee OA according to American College of Rheumatology (ACR) diagnostic criteria as well as national and international guidelines: knee pain and 3 of the following: > 50 years of age, morning stiffness >30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth; II: Reported knee pain ≥4 and ≤8 on the NRS, and ≥6 to ≤16 in number of repetitions of the 30 second chair stand test, at pre-randomization screening.
- •II: Able to handle a software program via phone, tablet or computer. III: Able to read and write the Swedish language.
排除标准
- •I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient
研究组 & 干预措施
Joint Academy
Online osteoarthritis treatment
干预措施: Online Osteoarthritis treatment (Behavioral)
The BOA program
Face-to-face osteoarthritis treatment
干预措施: Face-to-face osteoarthritis treatment (Behavioral)
结局指标
主要结局
Physical functioning
时间窗: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance
次要结局
- NRS pain(Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up)
- Self-reported function(Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up)
- Physical activity(Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up)
- Health-related quality of life(Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up)