Abstract
COVID-19 has forced medical research institutions to conduct clinical research remotely. Here, we describe how a university's mHealth Research Core helped facilitate the shift to remote research during the COVID-19 pandemic. In 2019 (pre-pandemic), we conducted stakeholder interviews and leadership group sessions to identify, create, and implement resources and core functions to support investigator-initiated mHealth research. Between April 2019 and February 2020, we identified four investigator needs: 1) a seminar series on trends in mHealth research, 2) mHealth case consultation services, 3) liaison services with institutional regulatory compliance groups, and 4) online navigation tools for implementation of mHealth methods (e.g., eConsent) and for building partnerships with technology vendors. To date, the mHealth Research Core has held seven seminars, completed 71 case consultations, assisted four COVID-related clinical studies, advised the IRB on shifting to remote research, and widely disseminated eConsent navigation tools. Although pre-pandemic stakeholder and investigator needs led to the creation of the mHealth Research Core, this institutional resource played a critical role in continuing clinical research during the pandemic by assisting investigators in rapidly shifting to remote study methodology.
Highlights
We chronicle the pre-pandemic development of a mobile health research core at a large US academic medical center by leveraging existing research infrastructure
The mHRC adapted an agile project management approach (See Figure 1) for developing mobile health (mHealth) research capabilities in an academic setting, and incorporated the process displayed in Figure 1. 14, 15, 16
The group established a set of core mHRC offerings to assist investigators, including providing 1) a seminar series to learn about new resources and trends in mHealth research, 2) case consultation to champion peer support and review of ideas, aims pages, manuscripts and grant proposal, 3) liaison services between groups and University Departments to promote collaborative projects, and 4) online navigation tools to offer guidance for eConsent, virtual sessions, 3rd Party technology partnerships, and computerized systems in FDA regulated trials
Summary
The emergence of the smartphone (iPhone, 2007 and Android, 2008)[1 ], was an inflection point for mobile technology, rapidly leading to the ubiquity of web-enabled mobile devices, and resulting in more than 85% in the US (in 2021) owning a smartphone and 67% of the global population being connected to mobile services (in 2019).[2, 3] Mobile technology is employed to conduct all aspects of clinical research, such as consenting participants, conducting study assessments and delivering treatment interventions with the aims of reducing participant burden, improving efficiency and innovation in research, and extending reach to underrepresented populations.[4, 5] Prior to the SARS-CoV-2/COVID-19 pandemic, the National Institutes of Health and the National Science Foundation had both prioritized a shift towards digital methods for conducting clinical studies – to achieve efficiencies and reduce costs, as well as to improve participant access and experience.[6, 7] As the world emerges from the pandemic, the scientific community finds itself in a similar situation: after witnessing transformational achievements in medical science – made possible in large part by technology – how do we continue to nurture science through innovation? 8, 9 Recognizing the importance of technology in safely continuing research and clinical care efforts, private and public investment in digital health innovation rose more than 60% in 2020. 10, 11, 12 The scientific community will benefit from continued funding opportunities, and academic research institutions adopting a digital infrastructure to support investigators in using and navigating mobile technology for clinical research and health care delivery.[4]. To ensure timely and safe mHealth modifications related to COVID-19, the mHRC leadership worked jointly with the Office of Information Security and the IRB to standardize methods for implementing e-consent This collaboration resulted in the mHRC developing online navigation tools for a) creating IRBapproved electronic informed consent using Research Electronic Data Capture (REDCap) and b) conducting study visits using virtual and telehealth technologies. No changes to the original research protocol were required to shift to fully remote study procedures, this study benefitted from mHRC assistance in building a partnership with a technology vendor that provided the healthyCMS Software as a Service (SaaS) product, making use of existing digital resources for eConsent (see Case 1), secure virtual video study visits and remotely training study interventionists We hope this description of the mHRC experience can serve as a roadmap for institutions facing what are likely to be universal needs at academic medical institutions: go-to resources for researchers across clinical areas looking to utilize digital tools in remote study methodology, the reduction of technical and regulatory delays, and the sharing of accumulating knowledge and experience within and between CTSA-supported academic institutions to achieve research aims and collaboration among mHealth researchers
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