The Health ePeople Resource for Mobilized Research

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 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.