Evaluation of a Web-based Platform for Osteoarthritis Treatment
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|ClinicalTrials.gov Identifier: NCT03328741|
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2017
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Behavioral: Online Osteoarthritis treatment Behavioral: Face-to-face osteoarthritis treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of a Web-based Platform for Osteoarthritis Treatment - a Randomized Clinical Trial|
|Actual Study Start Date :||May 22, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Joint Academy
Online osteoarthritis treatment
Behavioral: Online Osteoarthritis treatment
6 week online-program
Other Name: Joint Academy
Active Comparator: The BOA program
Face-to-face osteoarthritis treatment
Behavioral: Face-to-face osteoarthritis treatment
3 months face-to-face program
Other Name: The BOA program
- Physical functioning [ Time Frame: 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
- NRS pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328741
|Principal Investigator:||Håkan Nero, PhD||Department of Orthopaedics, Lund University|