Knee Arthroplasty Activity Trial (KArAT)

膝关节置换术活动试验 (KArAT)

• 批准号: 10517646
• 负责人: Elena Losina
• 金额: $ 81.12万
• 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/10517646
• 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; Lead; 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; Population; 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; clinical practice; comorbidity; cost; cost effective; cost effectiveness; critical period; design; economic incentive; evidence base; experience; financial incentive; fitbit; functional status; good diet; improved; improved functioning; 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 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.

总膝盖置换（TKR）通常用于减轻疼痛并改善患者的功能 晚期，有症状的膝盖骨关节炎（OA）。虽然超过80％的接受TKR报告的患者 越来越多的疼痛和功能状况，越来越多的证据表明，TKR后体育锻炼（PA）没有 超过tkr之前的水平。鉴于与TKR相关的大量时间和财务投资和富人 支持PA的健康益处的证据，TKR的有效性和成本效益可能是 有意义地增强了TKR接收者的身体活跃。急性TKR之后的时期 康复为这些患者改变生活方式提供了独特的机会之窗。这 提案解决了引入纳入固有和外在的行为策略是否引入 动机可以帮助TKR接收者参与持续，有意义的PA。电话主动教练 动机访谈（TAC（MI））使用定期对话来解决矛盾和确定的手段 克服宾夕法尼亚州的障碍。经济激励措施（FI）解决了完成健康之间的临时延迟 行为和通过立即奖励活动取决于活动和 表现。考虑到这些行为，心理和经济原则，我们提出了卡拉特 （膝关节置换术活动试验）。这项研究的长期目标是确定最多。 TKR后有效且具有成本效益的行为干预措施，以帮助患者发展持续的 致力于体育活跃。我们计划进行三臂并行RCT以建立 个性化干预措施的功效基于行为科学和行为经济学原则 在接受TKR的患者中改善PA。这三个臂将包括：臂1：通常的护理（UC）； 手臂2：注意控制（AC）；手臂3：电话主动教练（动机面试） +财务 激励措施（TAC（MI）+FI）。通常，RCT专注于特定治疗效应或总治疗效果。 在此应用程序中，我们提出了一种设计，该设计将允许我们估算两者。通过包括“通常的护理”手臂，我们 将能够估计干预的总体影响，这与估计的价值有关 干预和了解对临床实践的影响。主要结果将是 每周至少150分钟进行中度到vigot的体育锻炼（MVPA）≥3的个人 大都会大都会在六个月的干预措施结束时。平均每日步长的变化从tkr到结束 六个月的干预；更改MVPA的每周分钟；减少久坐时间；和 TKR后12、18和24个月的效率可持续性将是次要结果。结果 卡拉特将帮助临床医生，患者和政策制定者做出基于证据的决定，以改善PA之后 TKR，最常见的骨科手术之一。