Evaluation of a Web-based Platform for Osteoarthritis Treatment

Study Overview
=================
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.

Official Title
-----------------
Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Behavioral: Online Osteoarthritis treatment
* Behavioral: Face-to-face osteoarthritis treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint Academy<br>Online osteoarthritis treatment | Behavioral: Online Osteoarthritis treatment<br>* 6 week online-program<br>* Other names: Joint Academy;|
| Active Comparator: The BOA program<br>Face-to-face osteoarthritis treatment | Behavioral: Face-to-face osteoarthritis treatment<br>* 3 months face-to-face program<br>* Other names: The BOA program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Trials, Randomized, Telemedicine