Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Joint Academy | Experimental | Online osteoarthritis treatment |
|
| The BOA program | Active Comparator | Face-to-face osteoarthritis treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Osteoarthritis treatment | Behavioral | 6 week online-program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | Measured using the 30 second chair stand test, defined in number of repetitions. The result is directly reported after test performance | Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain | Self-reported knee pain on a 0-10 numeric rating scale (NRS) reported as during the latest week | Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up |
| Health-related quality of life |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HÃ¥kan Nero, PhD | Department of Orthopaedics, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abels Rehab | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30413507 | Derived | Nero H, Ranstam J, Kiadaliri AA, Dahlberg LE. Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study. BMJ Open. 2018 Nov 8;8(11):e022925. doi: 10.1136/bmjopen-2018-022925. |
Not provided
Not provided
De-identified IPD for primary and secondary outcomes will be made available upon request.
Study protocol, SAP and ICF will be made available six months after study completion. CSR and Analytic Code will be available after publication of results.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Face-to-face osteoarthritis treatment | Behavioral | 3 months face-to-face program |
|
|
Measured using the EQ5D-5L, index value. Measures the patients status at the day of reporting
| 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. | 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. | Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up |
| D012216 |
| Rheumatic Diseases |