Evaluation of a Web-based Platform for Osteoarthritis Treatment
- Conditions
- Osteoarthritis, Knee
- Interventions
- Behavioral: Face-to-face osteoarthritis treatmentBehavioral: Online Osteoarthritis treatment
- Registration Number
- NCT03328741
- Lead Sponsor
- Lund University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The BOA program Face-to-face osteoarthritis treatment Face-to-face osteoarthritis treatment Joint Academy Online Osteoarthritis treatment Online osteoarthritis treatment
- Primary Outcome Measures
Name Time Method Physical functioning 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
- Secondary Outcome Measures
Name Time Method Physical activity Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up Number of minutes of physical activity and exercise per week.
NRS pain Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week
Self-reported function Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up Measured using the KOOS-ps, for the latest week.
Health-related quality of life Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
Trial Locations
- Locations (1)
Abels Rehab
🇸🇪Malmö, Sweden