WellDoc® Publishes Framework for Developing Digital Therapeutics Programs That Improve Chronic Disease Outcomes

BALTIMORE, Feb. 24, 2016 -- Digital health technology leader WellDoc today announced that a manuscript outlining its framework for creating digital therapeutics technologies to treat chronic diseases has been published in the JMIR Research Protocols. The framework description, which is the first to integrate health behavior research, clinical trials and software technology, provides guidelines for producers of digital therapeutics applications (apps), mobile devices and other portable mobile health (mhealth) software and hardware to create more effective technology that leverages real-time coaching and feedback to improve self-management of chronic disease.

Currently, mobile technology has shown promise to revolutionize health services and patient self-management, but has not been proven to be very effective at changing health behaviors and outcomes. Many apps and mobile digital health technologies do not have structures that were designed in alignment with clinical trials results in chronic diseases, or with knowledge of health behaviors and effective intervention strategies for patients with chronic disease.

“This framework for the development of mobile health apps and digital therapeutics fills an important need for scalability, replicability and evidence-based information in medical mobile technology design. We see this as a best practices playbook for the health IT ecosystem at large,” said Anand K. Iyer, Ph.D., MBA, WellDoc’s Chief Strategy Officer. “Adopting the steps and processes outlined in our manuscript can help create effective technologies for different levels of many chronic diseases, and for apps that provide general healthcare information to U.S. Food & Drug Administration (FDA)-cleared technologies that provide customized, dynamic and adaptive interventions to manage chronic conditions.”

The framework developed by WellDoc, which was incorporated into the design and manufacture of BlueStar®, its own digital therapeutic to address behaviors and outcomes in type 2 diabetes, constitutes a new, systematic approach to mobile health technology development. The framework consists of a seven step “waterfall” process, in which outcomes and metrics, program objectives, changes in essential behaviors, customization and individual experience, evidence-based clinical and behavioral knowledge as well as “value drivers” like improved health, access or reduced costs, all determine the features and content of an app or other digital therapeutics technology.

Features in the final product can include educational videos, tips, a patient logbook, real-time feedback, medication adherence tools, tailored reports to providers and time-based “touchpoint” messages, or other tools that the waterfall research and development process identified as valuable for changing health outcomes. The WellDoc-developed framework was designed for initial use in managing type 2 diabetes, but it has been customized and applied to prototypes in other diseases, such as epilepsy, asthma, chronic obstructive pulmonary disease, HER2+ breast cancer, and low back pain. The framework’s design process intentionally focuses on technology intervention for the patient without a reliance on human intervention.

The paper, entitled “Evidence-based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework,” appears in the February 16, 2016 edition of the JMIR Research Protocols.ⁱ

About WellDoc®
WellDoc is a digital health technology company that develops mobile solutions to drive behavioral and clinical change in chronic disease. WellDoc’s goal is to improve patient self-management and help physicians overcome gaps in the delivery system to improve clinical outcomes and decrease cost.  WellDoc has commercialized BlueStar®, a digital therapeutic, for adults with type 2 diabetes. This therapeutic is designed to fill the support gap between patients and providers during the 8700 hours that individuals are living their lives outside the healthcare system. WellDoc has a proven track record of contributing published, peer-reviewed clinical evidence since 2008 and in June 2015 presented real-world patient engagement and clinical outcomes at the American Diabetes Association’s (ADA) 75^th Scientific Session. BlueStar is recognized by the ADA on its website as the first and only in the new class of diabetes treatment known as Mobile Prescription Therapy. In a recently published Forbes blog, WellDoc was named among one of five healthcare tech companies to watch in 2016. For more information, visit http://www.WellDoc.com and www.BlueStarDiabetes.com.

ⁱ Wilhide III CC, Peeples MM, Anthony Kouyaté RC Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework JMIR Res Protoc 2016;5(1):e25 URL: http://www.researchprotocols.org/2016/1/e25/ doi:10.2196/resprot.4838 PMID:26883135 

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