Home-based cardiac rehabilitation using a novel mobile health exercise regimen following transcatheter heart valve interventions (HOME RUN HITTER)

在老年人中，心脏瓣膜疾病很常见，通常需要瓣膜修复或 更换.过去需要心脏直视手术的手术现在可以用侵入性更小的经导管心脏来完成 瓣膜介入术（THVI），允许更少的发病率和更快的恢复。尽管安全和 THVI手术成功，超过一半的患者死亡，生活质量（QoL）差，和/或 THVI后1年住院。心脏康复（CR）可有效缓解这些不良结局， 心血管疾病患者，包括接受心脏瓣膜手术的患者。然而， 在医疗保险受益人中，只有25%的接受THVI的人参加了基于中心的CR（CBCR）， 突出了显著未满足的临床需求。为了满足这一需求，我们的长期目标是建立一个家园- 基于CR（HBCR）的计划，将CR的益处扩展到THVIs后的更多个体。我们的过度 假设HBCR移动的健康干预创新地解决了关键的目标健康行为 将减少临床事件并改善THVIs后的体力活动、功能能力和QoL， 互动式的提供和更长的积极干预时间将产生更大的效益。我们提出了一个 多中心随机对照试验招募了375名接受主动脉或二尖瓣THVI但未接受THVI的患者 打算参加CBCR;那些打算追求CBCR的人将在登记册中进行跟踪。参与者将 被分配到3个组：对照组（1）vs. HBCR移动的健康干预（2）vs.交互式（3） 交付.干预措施针对关键的目标健康行为，包括Apple Watch（以鼓励 体育活动和提醒健康生活）和运动处方（以建立力量/平衡）。 不干预组和交互式交付组接受相同的干预，但视频通话除外（每次 其他周）与运动生理学家（仅互动组）。每个干预组（不干预， 互动）将被随机分为12周和24周的积极干预持续时间。协同主要 终点为：（1）临床事件复合终点（死亡、再住院、专业护理机构访视）;以及（2） 平均每日总活动计数。关键次要终点：体力活动的量、强度、一致性; 6-分钟步行距离;和QoL。我们测试HBCR移动的健康干预（与对照组相比） 减少临床事件并改善THVI后的体力活动、功能能力和QoL（目标1）， 无论是交互式还是非手动交付（目标2），还是24周与12周的有效持续时间（目标3）， 干预产生更大的效益。我们还探讨了临床获益的介质和行为机制 变化随着人口老龄化，心脏瓣膜疾病的患病率和THVI的数量正在迅速增加。 克服与严重瓣膜疾病相关的残疾需要的不仅仅是简单地修复瓣膜; 如果不整合CR，THVI改善生活质量和数量的潜力就无法实现。如果成功，我们 该方法将优化护理价值和患者结局，并对其他患者人群产生广泛影响。

Among older adults, heart valve disease is common and often requires treatment with valve repair or replacement. What used to require open heart surgery can now be done with less invasive transcatheter heart valve interventions (THVIs), allowing for less morbidity and quicker recovery. However, despite the safety and procedural success of THVIs, over one-half of patients are dead, have poor quality of life (QoL), and/or are hospitalized 1 year after a THVI. Cardiac rehabilitation (CR) effectively mitigates these poor outcomes in patients with cardiovascular disease, including those undergoing heart valve procedures. However, among Medicare beneficiaries, only 25% of those undergoing a THVI participate in center-based CR (CBCR), which highlights a significant unmet clinical need. To address this need, our long-term goal is to develop a home- based CR (HBCR) program that extends the benefits of CR to more individuals after THVIs. Our over-arching hypothesis is that a HBCR mobile health intervention that innovatively addresses key target health behaviors will reduce clinical events and improve physical activity, functional capacity, and QoL after THVIs and that an interactive delivery and longer duration of the active intervention will produce greater benefits. We propose a multicenter randomized controlled trial enrolling 375 patients undergoing aortic or mitral THVIs who do not intend to participate in CBCR; those who intend to pursue CBCR will be followed in a registry. Participants will be assigned to 3 groups: control (1) vs. a HBCR mobile health intervention with hands-off (2) vs. interactive (3) delivery. The intervention addresses key target health behaviors and includes Apple Watch (to encourage physical activity and give reminders on healthy living) and an exercise prescription (to build strength/balance). The hands-off and interactive delivery groups receive the same intervention, except for a video call (every other week) with an exercise physiologist (interactive group only). Each intervention group (hands-off, interactive) will be randomized to 12-week vs. 24-week duration of the active intervention. The co-primary endpoints are: (1) clinical events composite (death, rehospitalization, skilled nursing facility visits); and (2) average daily total activity counts. Key secondary endpoints: amount, intensity, consistency of physical activity; 6-minute walk distance; and QoL. We test whether the HBCR mobile health intervention (compared to control) reduces clinical events and improves physical activity, function capacity, and QoL after THVI (Aim 1) and whether interactive vs. hands-ff delivery (Aim 2) or 24-week vs. 12-week active duration (Aim 3) of the intervention yields greater benefits. We also explore mediators of clinical benefit and mechanisms of behavior change. With population aging, prevalence of heart valve disease and number of THVIs are rapidly increasing. Overcoming disablement associated with severe valve disease requires more than simply fixing a valve; the potential of THVIs to improve quantity and quality of life is unfulfilled without integrating CR. If successful, our approach will optimize value of care and patient outcomes with broad implications for other patient populations.