Knee Arthroplasty Activity Trial (KArAT)

膝关节置换术活动试验 (KArAT)

• 批准号: 10709510
• 负责人: Elena Losina
• 金额: $ 74.71万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709510
• 关键词: Acute; Address; Adopted; Adult; Attitude; Behavior; Behavior Therapy; Behavioral; Behavioral Sciences; Belief; Centers for Disease Control and Prevention (U.S.); Clinical; Degenerative polyarthritis; Economics; Effectiveness; Ensure; Fatigue; Future; Grant; Health; Health Benefit; Implant; Incidence; Individual; Internet; Intervention; Investments; Knee; Knee Osteoarthritis; Life Style; Measures; Medical; Methodology; Mind; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Obesity; Operative Surgical Procedures; Orthopedic Surgery; Orthopedic Surgery procedures; Pain; Pain management; Patients; Performance; Persons; Physical activity; Policy Maker; Population; Prevention Guidelines; Public Health; Quality of life; Recommendation; Rehabilitation therapy; Reporting; Research; Rewards; Telephone; Testing; Time; Treatment Efficacy; Work; World Health Organization; arm; attentional control; behavior change; behavioral economics; clinical practice; comorbidity; cost; cost effective; cost effectiveness; critical period; design; economic incentive; evidence base; experience; financial incentive; fitbit; functional improvement; functional status; good diet; improved; innovation; intervention effect; knee replacement arthroplasty; moderate-to-vigorous physical activity; motivational enhancement therapy; multidisciplinary; multimodality; pain catastrophizing; pain reduction; pain relief; patient oriented; personalized intervention; poor sleep; post intervention; primary outcome; protocol development; psychologic; public health priorities; randomized trial; secondary outcome; sedentary; sleep quality; treatment as usual; treatment effect; tv watching; uptake; usual care arm

Total knee replacement (TKR) is commonly used to reduce pain and improve function in patients with advanced, symptomatic knee osteoarthritis (OA). While more than 80% of patients undergoing TKR report improved pain and functional status, growing evidence suggests that post-TKR physical activity (PA) does not surpass pre-TKR levels. Given the substantial time and financial investment associated with TKR and the rich evidence supporting health benefits of PA, the effectiveness and cost-effectiveness of TKR could be meaningfully enhanced if TKR recipients would be more physically active. The period following acute TKR rehabilitation provides a unique window of opportunity for these patients to transform their lifestyles. This proposal addresses whether introducing behavioral strategies that incorporate both intrinsic and extrinsic motivators can help TKR recipients engage in sustained, meaningful PA. Telephonic active coaching with motivational interviewing (TAC(MI)) uses regular conversations to resolve ambivalence and identify means of overcoming barriers to PA. Financial incentives (FI) address the temporal delay between completing healthy behaviors and receiving long-term health benefits by offering immediate rewards contingent on activity and performance. With these behavioral, psychological and economic principles in mind, we propose KArAT (Knee Arthroplasty Activity Trial). The long-term objective of this research is to determine the most effective and cost-effective behavioral interventions post-TKR to help patients develop a sustained commitment to becoming physically active. We plan to conduct a three-arm parallel RCT to establish the efficacy of personalized intervention built on the principles of behavioral science and behavioral economics in improving PA among patients who have undergone TKR. The three arms will include: Arm 1: Usual Care (UC); Arm 2: Attention Control (AC); Arm 3: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives (TAC(MI)+FI). In general, RCTs focus on either treatment-specific effect or total treatment effect. In this application, we propose a design that will permit us to estimate both. By including a ‘usual care’ arm, we will be able to estimate the overall effect of the intervention, which is relevant to estimating the value of the intervention and understanding the impact on clinical practice. The primary outcome will be the proportion of individuals engaging in at least 150 minutes per week of moderate-to-vigorous physical activity (MVPA) at ≥3 METs by the end of the six-month intervention. Change in average daily step count from pre-TKR to the end of the six-month intervention; change in weekly minutes of MVPA; reduction in sedentary time; and sustainability of efficacy at 12, 18 and 24 months post-TKR will be secondary outcomes. The results from KArAT will help clinicians, patients and policymakers make evidence-based decisions about improving PA after TKR, one of the most common orthopedic surgeries.

全膝关节置换术（TKR）通常用于减轻疼痛和改善患者的功能， 晚期、症状性膝关节骨关节炎（OA）。虽然超过80%的接受TKR的患者报告 疼痛和功能状态改善，越来越多的证据表明，TKR后体力活动（PA）并不 超过了TKR手术前的水平考虑到与TKR和富人相关的大量时间和金融投资， 支持PA的健康益处、TKR的有效性和成本效益的证据可能是 如果全膝关节置换术的接受者能够更加积极地进行身体活动，急性TKR后的时期 康复治疗为这些病人提供了一个独特的机会，使他们能够改变生活方式。这 一项提案提出了是否引入包含内在和外在的行为策略， 激励因素可以帮助TKR接受者进行持续的、有意义的PA。电话主动辅导， 动机访谈（TAC（MI））使用常规对话来解决矛盾心理，并确定 克服了PA的障碍。财政激励措施（FI）解决了完成健康教育和 行为和接受长期的健康福利，提供即时奖励视活动和 性能考虑到这些行为、心理和经济原则，我们提出了KArAT (Knee关节置换术活动试验）。这项研究的长期目标是确定最 TKR术后有效且具有成本效益的行为干预，以帮助患者形成持续的 致力于身体活动。我们计划进行一项三臂平行随机对照试验， 建立在行为科学和行为经济学原则基础上的个性化干预的有效性， 改善接受TKR的患者的PA。三个组将包括：组1：产后护理（UC）; 第2组：注意力控制（AC）;第3组：电话主动辅导（动机访谈）+财务 激励措施（TAC（MI）+FI）。一般而言，RCT侧重于治疗特异性效应或总治疗效应。 在本应用程序中，我们提出了一种允许我们估计两者的设计。通过包括“常规护理”手臂，我们 将能够估计干预的总体效果，这与估计 干预和理解对临床实践的影响。主要结果将是 每周至少进行150分钟中度至剧烈体力活动（MVPA）的个体，≥3 在六个月的干预结束时进行MET。从TKR前到TKR结束期间平均每日步数的变化 六个月的干预;每周MVPA分钟数的变化;久坐时间的减少;以及 TKR后12、18和24个月的疗效可持续性将是次要结局。的结果 KArAT将帮助临床医生、患者和政策制定者在治疗后做出关于改善PA的循证决策。 TKR，最常见的骨科手术之一。