Clinical trial NCT03328741: Evaluation of a Web-based Platform for Osteoarthritis Treatment
Official title: Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Clinical Trials, Randomized
Telemedicine
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical functioning
timeFrame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Secondary outcomes:
measure: NRS pain
timeFrame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
measure: Health-related quality of life
timeFrame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
measure: Self-reported function
timeFrame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
measure: Physical activity
timeFrame: Change from baseline to 6 months (3 months after end of treatment) and at 12 month follow-up
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Abels Rehab
Study officials:
affiliation: Department of Orthopaedics, Lund University
name: Håkan Nero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.