Remote Tai Chi for Knee Osteoarthritis: an Embedded Pragmatic Trial
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PROJECT SUMMARY/ABSTRACT Symptomatic Osteoarthritis (OA) affects over 32.5 million individuals in the U.S. and is a leading cause of disability and increasing medical costs. Toxicities associated with drug therapies for knee OA pain have caused the number of recommended treatments to decrease over time. There is now a critical shortage of treatment options for people with knee OA, especially because comorbidities that complicate treatment selection are highly prevalent in this older adult population. Tai Chi, a multi-dimensional practice that integrates physical, psychosocial, and behavioral components, has exhibited clinically significant improvements in chronic knee OA pain conditions. The American College of Rheumatology clinical practice guidelines strongly recommend Tai Chi as an intervention for knee OA. Recent studies conducted during the pandemic suggest that remotely delivered Tai Chi is a promising and scalable strategy for knee OA pain. However, critical gaps remain as to the real-world effectiveness of remote Tai Chi for knee OA and its implementation across multiple Health Care Systems. We propose an embedded, pragmatic, randomized trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention versus routine care across four Health Care Systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic Ohio and Cleveland Clinic Florida) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio, Southern Florida). We will enroll 480 patients with a clinical diagnosis of knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months. We hypothesize that implementation of remotely delivered Tai Chi is feasible across four Health Care Systems and that Tai Chi, compared to Routine Care, will improve physical health (including knee-related pain and function) and mental health as well as healthcare utilization. Our innovative study is the first rigorous multi-site pragmatic trial of a remote Tai Chi, in the multiple Health Care Systems utilizing web-based technology. It is designed to improve patient centered outcomes of knee OA. The results will enable widespread adoption of mind-body approaches for knee OA across Health Care Systems and lay the groundwork for future trials comparing the effectiveness of different implementation strategies.
PROJECT SUMMARY/ABSTRACT Symptomatic Osteoarthritis (OA) affects over 32.5 million individuals in the U.S. and is a leading cause of disability and increasing medical costs. Toxicities associated with drug therapies for knee OA pain have caused the number of recommended treatments to decrease over time. There is now a critical shortage of treatment options for people with knee OA, especially because comorbidities that complicate treatment selection are highly prevalent in this older adult population. Tai Chi, a multi-dimensional practice that integrates physical, psychosocial, and behavioral components, has exhibited clinically significant improvements in chronic knee OA pain conditions. The American College of Rheumatology clinical practice guidelines strongly recommend Tai Chi as an intervention for knee OA. Recent studies conducted during the pandemic suggest that remotely delivered Tai Chi is a promising and scalable strategy for knee OA pain. However, critical gaps remain as to the real-world effectiveness of remote Tai Chi for knee OA and its implementation across multiple Health Care Systems. We propose an embedded, pragmatic, randomized trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention versus routine care in 20-25 clinics across four Health Care Systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic Ohio and Cleveland Clinic Florida) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio, Southern Florida). We will enroll 600 diverse patients with a clinical diagnosis of knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months. We hypothesize that implementation of remotely delivered Tai Chi is feasible across four Health Care Systems and that Tai Chi, compared to Routine Care, will improve physical health (including knee- related pain and function) and mental health as well as healthcare utilization. Our innovative study is the first rigorous multi-site, embedded, pragmatic trial of a remote Tai Chi mind-body program, in the multiple Health Care Systems outpatient practice and utilizing web-based technology, designed to improve patient centered outcomes of knee OA. The results will enable widespread adoption of mind-body approaches for knee OA across Health Care Systems and lay the groundwork for future trials comparing the effectiveness of different implementation strategies.
