An exploratory virtual study in migraineurs to assess how migraine attacks correlate with activity level measured by Apple Watch and a ResearchKit based Migraine Tracker App

Gabriel Vargas gavargas@amgen.com

Abstract

The increasing costs of modern drug development have stimulated industry to identify novel approaches in the conduct of clinical trials. In particular, taking advantage of the tremendous progress made in consumer electronics over the last several years we have designed a “virtual” trial to understand the relationship between migraines and activity level as measured by an Apple Watch in a migraine patient population using a trial design which has no actual physical sites or study visits.

Prospective participants register, then download our Migraine Tracker App to their iPhone, and answer questions to determine their eligibility for the study. Each prospective participant who enrolls will first complete a consent process explaining the risks and benefits of the study and obtains an electronic informed consent (agreement) to participate in this study.

If accepted into the study, participants are mailed an Apple Watch which is used to track their activity level (number of steps). They are given instructions on documenting migraine episodes during the 90-day study period. Subjects are asked to answer questions on a daily and monthly basis as well as record the start and stop time of their migraine episodes throughout the 90-day period. The questionnaires take approximately 10-20 minutes to fill each day.

The participants coded study data is sent to the study team automatically from the mobile device on real-time basis for research study and data analysis. Participants are asked to contact Helpdesk support for any questions or malfunction of the Apple Watch or Migraine Activity App.

The participants are allowed to retain the Apple Watches after successful study completion and deactivation of all mobile applications.

The purpose of the study is to test the hypothesis that the changes in activity as tracked by number of steps per unit time will correlate with migraine occurrence. This presentation will give information on the study and discuss the challenges associated with performing a virtual study without any patient contact using mobile app-based informed consent, registration, and activity tracking.
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