HEART Camp Connect: Promoting Adherence to Exercise in Adults with Heart Failure with Preserved Ejection Fraction

HEART Camp Connect：促进射血分数保留的心力衰竭成人患者坚持锻炼

基本信息

批准号：
10657083
负责人：
Windy Williams Alonso
金额：
$ 70.27万
依托单位：
UNIVERSITY OF NEBRASKA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-15 至 2028-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10657083
关键词：
Adherence Adult Algorithms Area Attitude Behavior Therapy Behavioral Mechanisms Benchmarking Biological Assay Biological Markers Cardiovascular system Caring Clinical Congestive Heart Failure Cost Analysis Costs and Benefits Data Direct Costs EFRAC Evaluation Event Exercise Exercise Test Facilities and Administrative Costs Future Goals Guidelines Health Status Heart Rate Heart failure Hospitalization Inflammation Inflammatory Informal Social Control Injury Intervention Intervention Trial Measures Mediating Mediation Mediator Medicine National Heart, Lung, and Blood Institute Outcome Participant Patient Outcomes Assessments Patients Perception Persons Physical Function Physical activity Physiological Quality of life Randomized, Controlled Trials Recommendation Science Self Efficacy Subgroup Symptoms Testing Theoretical Studies Time Training Treatment Efficacy Work behavior change behavioral adherence clinical care cost effective cost-effectiveness ratio design efficacy testing exercise adherence exercise intensity exercise intervention exercise intolerance exercise training experience improved incremental cost-effectiveness innovation intervention cost intervention delivery mortality pharmacologic preservation primary outcome resistance exercise secondary analysis theories therapy design treatment as usual virtual virtual coach virtual delivery web app working group

项目摘要

PROJECT SUMMARY/ABSTRACT Heart failure with preserved ejection fraction (HFpEF) is one of the greatest treatment challenges in cardiovascular care today. Exercise is one of few treatments shown to benefit adults with HFpEF. Yet, to achieve and sustain the benefits of exercise, adherence is required. Recent National Heart Lung and Blood Institute (NHLBI) working groups on HFpEF and exercise in heart failure highlighted high priority areas for future study including examining strategies and interventions to promote exercise initiation and adherence, testing interventional mechanisms to improve adherence to exercise, identifying clinically meaningful outcomes for heart failure trials beyond mortality, and examining longitudinal changes in inflammatory biomarkers to better understand correlates to clinical status. Our team has successfully tested an intervention [Heart Failure Exercise and Resistance Training (HEART) Camp] that significantly improves long-term adherence to moderate intensity exercise (≥120 minutes of exercise at a heart rate reserve of 40-80%) in stable, chronic heart failure. Adherence was moderated by ejection fraction and a secondary analysis of our HFpEF subgroup showed promising long- term exercise adherence. We now propose a sufficiently powered randomized controlled trial to test the efficacy of 2 interventions in achieving long-term exercise adherence in adults with HFpEF. Our overall objectives align with NHLBI priorities and work toward achieving our long-term goal to promote adherence to exercise in HFpEF: (a) evaluate the effects of theory-based training and coaching interventions on long-term adherence to exercise, (b) identify minutes of moderate-intensity exercise that relate to clinically meaningful change in patient-reported outcomes, (c) evaluate interventional mechanisms and interim clinical events as mediators of adherence behaviors, and (d) examine the cost of intervention delivery. To meet these objectives, we propose a 3-group randomized controlled trial to compare 2 interventions, HEART Camp (in-person) to HEART Camp Connect (virtual) to each other and to enhanced usual care in adults with HFpEF. The proposed study incorporates several innovations: 1. We are the first to: test the effects of behavioral interventions designed to promote long-term exercise adherence in HFpEF using an objective measure of adherence, attempt to define a benchmark of minutes of exercise needed to achieve a clinically meaningful change, and assess exercise intervention cost; and 2. We incorporate technical innovations including a web application for real-time capture of exercise data, an innovative analytic approach that examines the influence of interim clinical events on adherence, a HFpEF algorithm and large-scale inflammatory assays. These innovations challenge the current paradigm and help to reach new horizons in HFpEF science. Our approach, which combines well-studied theoretical mechanisms delivered with virtual coaching and training tested against in-person coaching and training, will allow us to better understand exercise adherence in HFpEF. This study will have a critical impact by lessening non-adherence as a barrier to progress in the clinical care of adults with HFpEF through regular exercise training.

项目摘要/摘要保留的射血分数（HFPEF）是心力衰竭是最大的治疗挑战之一今天的心血管护理。锻炼是显示出HFPEF成年人的少数治疗方法之一。但是，要实现并维持锻炼的好处，需要依从性。最近的国家心脏肺和血液研究所（NHLBI）HFPEF和心力衰竭运动的工作组强调了未来研究的高优先级领域包括检查策略和干预措施以促进运动计划和依从性，测试介入的介入机制以提高依从性运动，确定心脏的有意义的有意义的结果超出死亡率的失败试验，并检查炎症生物标志物的纵向变化以更好了解与临床状况相关。我们的团队已成功测试了干预措施[心力衰竭运动和抵抗训练（心脏）训练营，可显着改善对现代强度的长期遵守稳定的慢性心力衰竭运动（以40-80％的心率储备为40-80％运动≥120分钟）。坚持通过射血分数和对我们的HFPEF亚组的次级分析来调节，有望长期术语锻炼依从性。现在，我们提出了一项足够动力的随机对照试验来测试效率在HFPEF成年人中实现长期运动遵守的两种干预措施。我们的整体目标保持一致有了NHLBI的优先事项，并致力于实现我们的长期目标，以促进遵守HFPEF的遵守：（a）评估基于理论的培训和教练干预措施对长期遵守运动的影响，（b）确定与患者报告中临床上有意义的变化有关的中等强度运动的分钟结果，（c）评估介入的介入者的介入机制和临时临床事件行为，以及（d）检查干预成本。为了实现这些目标，我们提出了一个3组随机对照试验比较2种干预措施，心脏营（面对面）与心脏营地连接（虚拟）彼此之间，并增强了HFPEF成年人的常规护理。拟议的研究结合了几个创新：1。我们是第一个：测试旨在促进长期的行为干预措施的影响使用客观的依从性在HFPEF中遵守，试图定义一个基准进行临床意义的变化所需的锻炼时间，并评估运动干预成本；和2。我们合并了技术创新，包括用于实时捕获锻炼数据的Web应用程序，一种创新的分析方法，检验了临时临床事件对依从性的影响，HFPEF 算法和大规模炎症测定法。这些创新挑战了当前的范式，并有助于到达HFPEF科学的新视野。我们的方法结合了研究良好的理论机制通过虚拟教练和训练进行了针对面对面的教练和培训的测试，将使我们能够更好了解HFPEF中的运动依从性。这项研究将通过降低不遵守性而产生关键的影响通过定期锻炼训练，成年人患有HFPEF的成年人临床护理的障碍。