Remote Tai Chi for Knee Osteoarthritis: an Embedded Pragmatic Trial

远程太极拳治疗膝骨关节炎：嵌入式实用试验

• 批准号: 10649920
• 负责人: Helen Lavretsky
• 金额: $ 91.17万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-19 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10649920
• 关键词: Adoption; Advisory Committees; Affect; Ambulatory Care Facilities; American; Analgesics; Behavioral; Boston; California; Chronic; Clinic; Clinical Practice Guideline; Clinical Trials; Clinical Trials Data Monitoring Committees; Data; Degenerative polyarthritis; Dimensions; Effectiveness; Elderly; Electronic Health Record; Enrollment; Ethics; Exercise; Exhibits; Florida; Future; Geographic Locations; Health; Health system; Healthcare Systems; Individual; Informed Consent; Injections; Internet; Intervention; Interview; Knee; Knee Osteoarthritis; Leadership; Los Angeles; Massachusetts; Medical Care Costs; Medical center; Mental Health; Mind-Body Intervention; Musculoskeletal; Ohio; Online Systems; Operative Surgical Procedures; Outcome; Outpatients; Pain; Pain interference; Participant; Patient-Focused Outcomes; Patients; Persons; Pharmacotherapy; Phase; Population; Procedures; Provider; Psyche structure; Quality Control; Recommendation; Replacement Arthroplasty; Research Design; Rheumatology; Selection for Treatments; Site; Structure; Surveys; System; Tai Ji; Technology; Testing; Time; Toxic effect; United States National Institutes of Health; Universities; clinical diagnosis; clinically significant; collaboratory; college; comorbidity; compare effectiveness; design; digital; disability; experience; follow-up; health care service utilization; implementation strategy; improved; innovation; knee pain; mind/body; organizational structure; osteoarthritis pain; pandemic disease; physical conditioning; pragmatic trial; primary care setting; primary outcome; programs; psychosocial; randomized trial; recruit; reduce symptoms; remote delivery; retention rate; routine care; secondary outcome; social; trial comparing; working group

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.

项目概要/摘要 症状性骨关节炎 (OA) 影响着美国超过 3250 万人，是导致以下疾病的主要原因 残疾和增加的医疗费用。与膝骨关节炎疼痛药物治疗相关的毒性 导致推荐治疗的数量随着时间的推移而减少。现在严重短缺 膝骨关节炎患者的治疗选择，特别是因为合并症使治疗变得复杂 选择在老年人群中非常普遍。 太极拳是一种集身体、心理和行为于一体的多维练习， 在慢性膝关节骨关节炎疼痛方面表现出临床显着改善。美国学院 风湿病临床实践指南强烈推荐太极拳作为膝关节骨关节炎的干预措施。最近的 大流行期间进行的研究表明，远程太极拳是一种有前途且可扩展的方法 膝关节 OA 疼痛的策略。然而，远程太极拳在现实世界中的有效性仍然存在重大差距 膝关节骨关节炎及其在多个医疗保健系统中的实施。 我们提出了一项嵌入式、务实的随机试验，该试验将比较为期 3 个月、每周两次的效果 四个医疗保健机构 20-25 家诊所远程提供的基于网络的太极拳干预与常规护理的比较 系统（塔夫茨医疗中心、波士顿医疗中心、加州大学洛杉矶分校健康中心和 俄亥俄州克利夫兰诊所和佛罗里达州克利夫兰诊所）在四个地理区域（马萨诸塞州东部、 南加州、俄亥俄州东北部、佛罗里达州南部）。我们将招募 600 名不同的患者进行临床研究 膝关节骨关节炎的诊断。参与者将在基线和 3 个月时接受评估，并在 6 个月时进行额外随访 和12个月。我们假设远程太极拳的实施在四个方面都是可行的 医疗保健系统，与常规护理相比，太极拳将改善身体健康（包括膝关节） 相关的疼痛和功能）和心理健康以及医疗保健利用。 我们的创新研究是首次对远程太极身心进行严格的多地点、嵌入式、实用性试验 计划，在多个医疗保健系统门诊实践中并利用基于网络的技术，设计 改善以患者为中心的膝关节骨关节炎的治疗结果。研究结果将使身心疗法得到广泛采用 跨医疗保健系统的膝关节 OA 方法，并为未来比较试验奠定基础 不同实施策略的有效性。