Knee Arthroplasty AcTivity (KArAT) Trial

膝关节置换术活动 (KArAT) 试验

• 批准号: 9883957
• 负责人: Elena Losina
• 金额: $ 46.33万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-17 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9883957
• 关键词: Acute; Address; Adopted; Adult; Attitude; Behavior; Behavior Therapy; Behavioral; Behavioral Sciences; Belief; Centers for Disease Control and Prevention (U.S.); Chronic Disease; Clinical; Degenerative polyarthritis; Economics; Effectiveness; Ensure; Fatigue; Future; Guidelines; Habits; Health; Health Benefit; Healthy Eating; Implant; Incidence; Individual; Internet; Intervention; Investments; Knee; Knee Osteoarthritis; Lead; Life Style; Measures; Methodology; Mind; Obesity; Operative Surgical Procedures; Orthopedic Surgery procedures; Orthopedic Surgical Procedures; Outcome; Pain; Patients; Performance; Persons; Physical activity; Prevention Guidelines; Public Health; Quality of life; Rehabilitation therapy; Reporting; Research; Rewards; Telephone; Testing; Time; Treatment Efficacy; Work; World Health Organization; arm; attentional control; behavior change; behavioral economics; budget impact; clinical practice; comorbidity; cost; cost effective; cost effectiveness; critical period; design; economic incentive; evidence base; experience; financial incentive; fitbit; functional status; improved; improved functioning; innovation; intervention effect; knee replacement arthroplasty; moderate-to-vigorous physical activity; motivational enhancement therapy; multidisciplinary; multimodality; pain reduction; pain relief; patient oriented; personalized intervention; post intervention; primary outcome; protocol development; psychologic; public health priorities; randomized trial; secondary outcome; sedentary; sedentary lifestyle; 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 investments 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 healthful 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功能 晚期症状性膝骨性关节炎(OA)。而超过80%的接受TKR的患者报告说 疼痛和功能状态的改善，越来越多的证据表明，TKR后的体力活动(PA)并不 超过TKR前的水平。考虑到与将军澳线和富人相关的大量时间和财务投资 支持PA的健康益处的证据，TKR的有效性和成本效益可能是 如果TKR接受者的身体活动更多，这将有意义地增强。急性TKR后的时期 康复为这些患者提供了一个改变其生活方式的独特机会之窗。这 提案涉及是否引入同时包含内在和外在的行为策略 激励因素可以帮助TKR接受者参与持续的、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PA的障碍。财政激励(FI)解决了在完成健康的 行为和获得长期健康福利，根据活动和活动提供即时奖励 性能。考虑到这些行为、心理和经济原则，我们建议使用卡拉特 (膝关节置换活动度试验)。这项研究的长期目标是确定最 TKR术后有效且成本效益高的行为干预措施，帮助患者形成持续的 致力于锻炼身体。我们计划进行一项三臂并行RCT，以建立 基于行为科学和行为经济学原理的个性化干预的有效性 改善接受TKR的患者的PA。这三个手臂将包括：手臂1：日常护理(UC)； ARM 2：注意力控制(AC)；ARM 3：电话主动辅导(激励性访谈)+财务 激励措施(TAC(MI)+FI)。一般而言，随机对照试验侧重于特定治疗效果或总体治疗效果。 在此应用程序中，我们提出了一种设计，使我们能够估计两者。通过增加一个“日常护理”的手臂，我们 将能够估计干预的总体影响，这与估计 干预和了解对临床实践的影响。主要结果将是 在≥3进行每周至少150分钟中等到剧烈的体力活动的个人 METS在为期六个月的干预结束前。从TKR前到TKR结束时的日均步数变化 为期六个月的干预；每周MVPA分钟的变化；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果。结果来自于 KARAT将帮助临床医生、患者和政策制定者做出关于改善PA的循证决策 继TKR之后，最常见的整形外科手术之一。