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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
6 week online-program
3 months face-to-face program
Abels Rehab
Malmö, Sweden
Physical functioning
Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance
Time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
NRS pain
Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week
Time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Health-related quality of life
Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
Time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Self-reported function
Measured using the KOOS-ps, for the latest week.
Time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Physical activity
Number of minutes of physical activity and exercise per week.
Time frame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
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