Outcomes Measured via Mobile Devices

Choosing and Specifying Endpoints and Outcomes


Section 5


Outcomes Measured via Mobile Devices

Contributors

Lesley Curtis, PhD

Adrian F. Hernandez, MD, MHS

Kevin P. Weinfurt, PhD

 

Contributing Editor

Karen Staman, MS

The use of mobile technologies (such as smartphones, tablet computers, and portable, implantable, or wearable medical devices), known collectively as “mobile health” or “mHealth” devices present a wide array of challenges and opportunities for medical research. There is much to be learned about how well these devices work, their validity and reliability. While these devices hold abundant promise, they are imperfect measures and are not commonly used in clinical trials (Clinical Trials Transformation Initiative 2016). For example, if a participant is wearing an activity monitor and claps at a concert, it is possible that the device could record this as running? Or, will a geo-spatial device record running on a treadmill as activity at all?

Some examples of the utility of these devices include:

  • A PCT can be designed where a patient has an application (app) for their phone that provides passive or active surveillance. For example, an app with geo-sensing can ping a person who enters the hospital with the question: Why are you in the hospital? Or Are you ill?
  • The Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) trial will us mobile phone technology to remind patients about medication adherence.
  • Some mHealth devices will transmit data about a participant’s health status to a data warehouse every night. The devices can measure physiologic functions, such as how active a person is, heart rate, etc. As a hypothetical example in a PCT designed to evaluate how to prevent cardiac death, a patient could wear a heart monitor that detects arrhythmias and other heartbeat abnormalities, as well as whether or not a patient is hospitalized.
  • Patients with type 1 diabetes can use continuous glucose monitors (CGMs) to monitor their blood glucose levels, and this information can be sent to a smartphone, and CGM-specific receiver, or an insulin pump (Clinical Trials Transformation Initiative 2016).

The Clinical Trials Transformation Initiative (CTTI) recently announced recommendations for advancing the use of mobile technology for data capture and improved clinical trials. The recommendations include advice on selecting the right technology; collecting, analyzing, and interpreting data; managing data; protocol design and execution; and FDA submission and inspection. To learn more, watch the webinar.

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REFERENCES

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Clinical Trials Transformation Initiative. 2016. Developing Novel Endpoints Generated by Mobile Technology for use in Clinical Trials. https://www.ctti-clinicaltrials.org/projects/novel-endpoints. Accessed July 24, 2017.


Version History

December 4, 2018: Updated text as part of annual review and added resources column (changes made by K. Staman).

Published August 25, 2017

Citation:

Curtis L, Hernandez A, Weinfurt K. Choosing and Specifying Endpoints and Outcomes: Outcomes Measured via Mobile Devices. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/chapters/design/choosing-specifying-end-points-outcomes/outcomes-measured-via-mobile-devices/. Updated December 4, 2018. DOI: 10.28929/013.