mHealth for Heart Failure Symptom Monitoring

 描述(由申请人提供)：在了解更好的方式让心力衰竭(HF)患者参与症状识别、反应和与医疗保健提供者的沟通方面存在根本差距。症状是心力衰竭患者健康相关结果的主要驱动力，也是再次住院的主要驱动力。鉴于我们位于纽约市的华盛顿高地社区，这是一个主要是贫穷的拉丁裔社区，我们处于独特的地位，可以使用移动健康(MHealth)应用程序(APP)解决拉丁裔心力衰竭患者以及其他心力衰竭患者的临床结果中的健康差异。NIH K99/R00应用程序的拟议长期目标是帮助候选人Masterson Creber博士成为一名独立调查员，其研究计划侧重于高质量、基于技术的行为健康干预，以改善结局并支持以患者为中心的心力衰竭患者的心血管护理。拟议项目的总体目标是检验这样一个假设，即一种新的APP，mi.症状可以有意义地改变患者报告的和心力衰竭患者的临床结果，并导致更成功的症状识别、反应和与医疗保健提供者的沟通。中心假设是，使用技术支持的临床点症状报告干预(mi.symptoms)使患者能够更好地控制他们的症状体验，可以有意义地改变心力衰竭患者的症状反应行为和临床结果。在强大的初步数据的指导下，这一假设将在研究的K99阶段通过追求以下具体目标来测试：1)测试mi.Symptoms(由Masterson Creber博士和哥伦比亚大学工程学院的一个团队开发的一种新型mHealth应用程序)的可靠性和有效性；以及2)评估mi.Symptoms的可用性，并在一项试点可行性研究中检查其使用与患者报告结果变化的关系。在研究的R00阶段，具体目的是：3)检查与常规护理相比在改善患者报告和临床结果方面的有效性和症状。K99/R00独立之路奖的培训计划将使Masterson Creber博士能够将生物医学信息学方面的技能与临床试验设计和结果研究结合起来。 该方法有三个创新特征：1)它基于动态系统中的情境感知理论；2)理论模型与MID独特的功能元素之间有密切的联系。Symptoms Web应用程序(通过选择化身来定制患者偏好，提示报告症状，以享乐动机加强症状报告，并减少障碍以促进与提供者的沟通)；以及3)它应用增长建模来分析随时间推移的多个症状和结果。这项研究的结果将为mi.Symptoms和许多其他mHealth应用程序的开发和测试提供见解。这项研究意义重大，因为它解决了心力衰竭患者难以识别和应对症状的重要问题，也解决了拉丁裔患者心力衰竭结局中的健康差距。为了实现这项拟议研究的目标，已经建立了一个由国际和国内公认的专家组成的强大的指导团队，其中包括生物医学信息学方面的专业知识，重点是mHealth(Suzanne Bakken博士)、心血管行为健康和临床试验设计(Karina Davidson博士)、以用户为中心的设计(Steven Feiner博士)、临床心力衰竭管理(Mathew Maurer博士)、症状监测(凯瑟琳·希基博士)、定量方法学(Christopher Lee博士)以及mHealth应用程序开发和测试(Cornelia Ruland博士)。由于候选人作为一名独立科学家的职业生涯需要一系列关于生物医学信息学、计算机科学和用户界面以及行为健康临床试验设计的新知识和技能，因此K99/R00奖对于实现候选人的职业目标并扩大慢性病脆弱患者的症状科学和自我管理科学将是极其重要和必要的。

 DESCRIPTION (provided by applicant): There is a fundamental gap in understanding better ways to engage patients with heart failure (HF) in symptom recognition, response, and communication with healthcare providers. Symptoms are the main driver of health- related outcomes for patients with HF and the primary driver of repeated hospital readmissions. Given that we are located in the Washington Heights neighborhood of New York City, a predominantly poor Latino community, we are uniquely positioned to address the health disparity in clinical outcomes for Latino patients with HF as well as others with HF using a mobile health (mHealth) application (app). The proposed long-term goal of this NIH K99/R00 application is to assist the candidate, Dr. Masterson Creber, in becoming an independent investigator with a program of research focusing on high quality, technology-based behavioral health interventions to improve outcomes and support patient-centered cardiovascular care for underserved patients with HF. The overall objective of the proposed project is to test the hypothesis that a novel app, mi.Symptoms can meaningfully alter patient-reported and clinical outcomes of patients with HF and lead to more successful symptom recognition, response and communication with healthcare providers. The central hypothesis is that empowering patients to take more control of their symptom experience using a technology-enabled point-of-care symptom reporting intervention (mi.Symptoms) can meaningfully alter symptom response behaviors the clinical outcomes of patients with HF. Guided by strong preliminary data, this hypothesis will be tested in the K99 phase of the study by pursing the following specific aims: 1) test the reliability and validity of mi.Symptoms (a novel mHealth app developed by Dr. Masterson Creber and a team from Columbia University School of Engineering), and 2) assess the usability of mi.Symptoms and examine relationships of its use with changes in patient-reported outcomes in a pilot feasibility study. In the R00 phase of the study, the specific aim is to: 3) examine the efficacy o mi.Symptoms on improving patient-reported and clinical outcomes as compared to usual care. The training plan for this K99/R00 Pathway to Independence Award will enable Dr. Masterson Creber to couple skills in biomedical informatics with clinical trial design and outcomes research. The approach has three innovative features: 1) it is grounded in the Theory of Situation Awareness in Dynamic Systems; 2) there is a close link between the theoretical model and unique functional elements of the mi.Symptoms web app (tailoring to patient preference by choosing an avatar, prompting to report symptoms, reinforcing symptom reporting with hedonic motivation, and decreasing barriers to facilitate communication with providers); and 3) it applies growth modeling to the analysis of multiple symptoms and outcomes over time. Findings from this study will provide insights into the development and testing of mi.Symptoms as well as many other mHealth apps. The research is significant because it addresses the important problem of patients with HF struggling to recognize and respond to their symptoms, and it addresses the health disparity in HF outcomes for Latino patients. To accomplish the aims of this proposed study, a robust mentorship team with internationally and nationally recognized experts has been built, including expertise in biomedical informatics with a focus on mHealth (Dr. Suzanne Bakken), cardiovascular behavioral health and clinical trial design (Dr. Karina Davidson), user-centered design (Dr. Steven Feiner), clinical heart failure management (Dr. Mathew Maurer), symptom monitoring (Dr. Kathleen Hickey), quantitative methodologies (Dr. Christopher Lee), and mHealth application development and testing (Dr. Cornelia Ruland). Since a spectrum of new knowledge and skills regarding biomedical informatics, computer science and user-interfaces, and behavioral health clinical trial design are required for the candidate's career as an independent scientist, this K99/R00 award will be extremely important and necessary to achieve the candidate's career objectives and expand symptom science and the science of self- management for vulnerable patients with chronic diseases.