The Health ePeople Resource for Mobilized Research

 描述（由申请人提供）：我们寻求创建健康ePeople资源，一个灵活，易于访问和可靠的基础设施进行移动健康研究。这项工作将建立在目前的健康电子心脏研究基础上，这是一个基于互联网的临床研究平台，已招募了来自世界各地的20，000多名参与者。虽然最初是为了研究心血管疾病而开发的，但Health eHeart被多个领域的研究人员使用，并帮助我们启动当前RFA中规定的许多目标。我们已经成功实施了一个用户友好的界面，用于收集患者报告的结果，验证的调查数据，以及与多个传感器，设备和应用程序的集成;我们有一个IRB批准的系统，使用模块化电子同意;我们有超过20，000名有兴趣为移动健康研究做出贡献的参与者;我们为外部调查人员开发了以定制方式利用和招募他们自己的参与者的方法;我们开发了一个研究管理门户网站，（包括实时仪表板和基于参与者特征的过滤系统）和可供外部调查人员使用的灵活的信息系统;我们建立了一个数据库和数据管理系统，其结构符合隐私、安全和可靠性的最高标准;我们对平台进行了迭代和调整，以利用新兴技术和尖端方法。基于这些优势，我们准备充分利用该奖项提供的机会，将Health eHeart研究转变为一般的Health ePeople资源。Health ePeople的主要目标是提供一种资源，使移动健康研究变得方便和有效。该资源将帮助研究人员通过与传感器，设备和应用程序集成来收集mHealth数据，提供在线调查，与包括电子健康记录在内的外部数据源连接，并使用新方法来确定和裁定临床结局事件。该资源将支持利用已经登记在健康ePeople队列中的患者或外部招募的参与者的“共同登记”（和数据链接）。我们将利用我们的经验，吸引并同意超过20，000名患者，以发展和扩大一个有兴趣为移动健康研究做出贡献的全球参与者队列（健康ePeople队列）。该平台将支持应用程序的开发和验证，包括随机对照试验。这一努力将利用我们与基金会和患者倡导团体合作的经验，以及我们在PCORnet中的地位，以及由此产生的与多个大型PCORI资助的临床数据研究网络的合作关系，这些网络可以提供对数亿患者及其电子健康记录的访问。我们将开发技术、程序和管理，以支持快速访问健康电子人群，进行研究、数据共享、分析和与外部数据库集成。最后，我们将开发和测试各种模型，以提供健康电子人资源和服务，确保在奖励期后的财务可持续性。

 DESCRIPTION (provided by applicant): We seek to create the Health ePeople Resource, a nimble, readily-accessible, and reliable infrastructure to conduct mHealth research. This effort will build on the current Health eHeart Study, an internet-based clinical research platform that has enrolled more than 20,000 engaged participants from around the world. Although initially developed to study cardiovascular disease, Health eHeart is in use by investigators from multiple fields, and helps us jumpstart many of the objectives set out in the current RFA. We have successfully implemented a user-friendly interface built to collect patient-reported outcomes, validated survey data, and integrations with multiple sensors, devices, and apps; we have an IRB approved system using modular electronic consenting; we have over 20,000 deeply involved participants interested in contributing to mHealth research; we have developed ways for external investigators to utilize and enroll their own participants in a customizable fashion; we have developed a study management portal (including a real-time dashboard and participant characteristic- based filtering system) and a flexible messaging system that can be utilized by external investigators; we have built a database and data management system constructed to adhere to the highest standards of privacy, security, and reliability; and we have iterated and adapted the platform to take advantage of emerging technology and cutting-edge methods. Building from these strengths, we are ready to fully leverage the opportunities afforded by this award, transforming the Health eHeart Study into a general Health ePeople Resource. The primary goal of Health ePeople will be to provide a resource that enables convenient and efficient mHealth research. The Resource will help investigators collect mHealth data via integration with sensors, devices, and apps, deliver online surveys, connect with external data sources including electronic health records, and use novel methods for ascertaining and adjudicating clinical outcome events. The Resource will support utilization of patients already enrolled in the Health ePeople Cohort or "co-enrollment" (and data linkage) of participants recruited externally. We will utilize our experience engaging and consenting more than 20,000 patients to grow and expand a world-wide cohort of participants (the Health ePeople Cohort) interested in contributing to mHealth research. The platform will support development and validation of apps, including randomized controlled trials. This effort will leverage our experience working with foundations and patient-advocacy groups as well as our position in PCORnet and the resultant collaborative relationships with multiple large PCORI-funded Clinical Data Research Networks that can provide access to hundreds of millions of patients and their electronic health records. We will develop the technology, procedures and governance to support rapid access to the Health ePeople cohort for research, data sharing, analyses and integration with external databases. Finally, we will develop and test various models for providing access to Health ePeople resources and services that will assure financial sustainability beyond the award period.