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

经导管心脏瓣膜介入治疗后使用新型移动健康锻炼方案进行家庭心脏康复（全垒打）

• 批准号: 10623250
• 负责人: Brian Richard Lindman
• 金额: $ 75.39万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10623250
• 关键词: Activities of Daily Living; Address; Aorta; Apple watch; Behavioral Mechanisms; Behavioral Sciences; Cardiac Surgery procedures; Cardiac rehabilitation; Cardiovascular Diseases; Cessation of life; Clinical; Complement; Counseling; Disease; Elderly; Equilibrium; Event; Exercise; Exercise Physiology; Future; Geriatrics; Goals; Habits; Hand; Health Technology; Health behavior; Heart Valve Diseases; Heart Valves; Home; Hospitalization; Individual; Intervention; Learning; Measures; Mediator; Medicare; Mobile Health Application; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Participant; Patient Participation; Patient-Focused Outcomes; Patients; Physical activity; Pilot Projects; Prevalence; Procedures; Quality of life; Randomized; Randomized, Controlled Trials; Recovery; Registries; Research Design; Running; Safety; Skilled Nursing Facilities; Social support; Specific qualifier value; Subgroup; Testing; Translations; Visit; Walking; Work; aging population; aortic valve; behavior change; beneficiary; care outcomes; clinically relevant; clinically significant; comparison control; design; digital tool; efficacy/implementation trial; exercise physiologist; exercise prescription; exercise regimen; fitbit; group intervention; home test; hospital readmission; improved; infancy; innovation; mHealth; mortality; multidisciplinary; novel; participant enrollment; patient population; pilot trial; primary endpoint; programs; repaired; secondary endpoint; success; therapy design; trial enrollment; video chat; virtual intervention

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.

在老年人中，心脏瓣膜疾病很常见，通常需要对阀修复或 替代品。现在可以用较小的侵入性经导管心脏进行开放心脏手术的方法 阀门干预（THVI），允许更少的发病率和更快的恢复。但是，尽管有安全性和 THVI的程序成功，一半以上的患者死亡，生活质量差（QOL）和/或 THVI后1年住院。心脏康复（CR）有效地减轻了这些差的结果 心血管疾病的患者，包括接受心脏瓣膜手术的患者。但是，中间 Medicare受益人，只有25％接受THVI的人参加中心CR（CBCR），这 突出了巨大的未满足临床需求。为了满足这一需求，我们的长期目标是开发房屋 - 基于CR（HBCR）计划将CR的好处扩展到THVI后更多个体。我们的整理 假设是HBCR移动健康干预措施，该干预措施是对关键目标健康行为的创新 将减少临床事件并改善THVI后的体育活动，功能能力和QoL 互动交付和较长的主动干预持续时间将产生更大的好处。我们提出了一个 多中心随机对照试验招募了375例不接受主动脉或二尖瓣的患者 打算参加CBCR；那些打算追求CBCR的人将在注册表中遵循。参与者会 分配给3组：控制（1）与HBCR移动健康干预措施（2）与互动（3） 送货。干预措施解决了关键目标健康行为，包括Apple Watch（鼓励 体育锻炼并提醒健康生活）和运动处方（以建立力量/平衡）。 除视频通话外（每一个 其他一周）与运动生理学家（仅仅是互动组）。每个干预组 互动）将随机分配至12周与主动干预持续时间的24周持续时间。共同主要 终点是：（1）临床事件综合（死亡，复兴，熟练的护理设施访问）； （2） 平均每日总活动计数。关键的次要终点：数量，强度，体育锻炼的一致性； 步行6分钟的距离；和QOL。我们测试HBCR移动健康干预（与对照相比）是否 减少临床事件并改善THVI之后的体育活动，功能能力和QoL（AIM 1）和 是交互式与动手交付（AIM 2）还是24周与12周的活动持续时间（AIM 3） 干预会带来更大的好处。我们还探索了临床益处和行为机制的调解人 改变。随着人口衰老，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不仅需要简单地固定阀门。这 如果不整合CR，则THVI的提高数量和生活质量的潜力无法实现。如果成功，我们的 方法将优化护理价值和患者结果，对其他患者人群具有广泛的影响。