Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial

BACKGROUND: Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular symptoms (fatigue, sleep disorders, anxiety and depression) and a reduction of life quality. Studies have revealed that patients with OA benefitted from enhanced management via telemedicine. Guangdong Online Hospital (GOH) is the first officially recognized web-based hospital that provides telemedicine service in China. However, the effective implementation of GOH telemedicine (GOHT) to enhance management for patients with OA remains unknown. METHODS/DESIGN: An assessor-blinded, parallel randomized controlled trial will be performed to study the feasibility and effectiveness of GOHT in the enhanced management of OA. Forty participants with knee OA will be recruited for a 6-month study. Patients meeting the inclusion criteria will be randomly allocated to receive conventional therapy (CT) or conventional therapy plus a brief GOH-based intervention (CT-GOHT). The primary outcome is the feasibility of a full-scale randomized controlled trial. The secondary outcomes include the self-reported total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index (PSQI) and the Hospital Anxiety and Depression Scale (HADS). Assessments will be performed at baseline, 2 weeks, 3 months and 6 months later after the initiation of the study. DISCUSSION: This trial is intended to test the application of GOHT in the chronic management in knee OA. The hypothesis is that OA patients may receive disease management via this network platform conveniently and effectively, especially those in the remote areas of our country. GOHT telemedicine would be an attractive alternative to traditional methods for disease management in knee OA. The results could provide preliminary experiences and guidance for an upcoming full-scale randomized controlled trial (RCT) in disease management via telemedicine. TRIAL REGISTRATION: ChiCTR: ChiCTR1800014465 . Registered on 16 January 2018.