Osteoarthritis, Knee
Conditions
Keywords
Clinical Trials, Randomized, Telemedicine
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.
Interventions
BEHAVIORALOnline Osteoarthritis treatment
6 week online-program
BEHAVIORALFace-to-face osteoarthritis treatment
3 months face-to-face program
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
I: Neurological disease, inflammatory joint disease or cancer. II: Cognitive disorder, e.g. dementia. III: Exercise is contra-indicated for the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
Countries
Sweden
Outcome results
None listed