Evaluation of a Web-based Platform for Osteoarthritis Treatment

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03328741
• Other study ID #: OA-treatment RCT
• Status: Suspended
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 270
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Online Osteoarthritis treatment
6 week online-program
• Face-to-face osteoarthritis treatment
3 months face-to-face program

Locations

Country	Name	City	State
Sweden	Abels Rehab	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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