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）通常用于减轻患有以下疾病的患者的疼痛并改善功能 超过 80% 接受 TKR 的患者报告患有晚期、有症状的膝骨关节炎 (OA)。 改善疼痛和功能状态，越来越多的证据表明 TKR 后体力活动 (PA) 不会 考虑到与 TKR 和富人相关的大量时间和财务投资。 有证据支持 PA 对健康有益，TKR 的有效性和成本效益可能是 如果 TKR 接受者在急性 TKR 后的一段时间内更加积极地进行身体活动，则效果会显着增强。 康复为这些患者改变生活方式提供了独特的机会。 提案涉及是否引入包含内在和外在的行为策略 激励者可以帮助 TKR 接受者进行持续、有意义的电话主动辅导。 动机性访谈 (TAC(MI)) 使用定期对话来解决矛盾心理并确定解决问题的方法 财务激励（FI）解决了健康完成障碍之间的时间延迟。 通过根据活动和行为提供即时奖励来获得长期健康益处 考虑到这些行为、心理和经济原则，我们提出了 KArAT。 （膝关节置换术活动试验）。这项研究的长期目标是确定最有效的方法。 TKR 后有效且具有成本效益的行为干预措施可帮助患者建立持续的 我们计划进行一项三臂平行随机对照试验来建立 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。这三个组包括： 第 1 组：常规护理 (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，随机对照试验侧重于治疗特异性效果或总体治疗效果。 在此应用中，我们提出了一种设计，通过包含“常规护理”臂，我们可以对两者进行估计。 将能够估计干预措施的总体效果，这与估计干预措施的价值相关 干预和了解对临床实践的影响的主要结果将是比例。 每周至少进行 150 分钟中度至剧烈体力活动 (MVPA) ≥3 的个人 六个月干预结束时的平均每日步数从 TKR 前到干预结束时的变化。 六个月的干预；每周静坐时间的变化； TKR 后 12、18 和 24 个月的疗效可持续性将是次要结果。 KArAT 将帮助新移民、患者和政策制定者就改善 PA 做出基于证据的决策 继 TKR 之后，最常见的骨科手术之一。