Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers
Status:
Terminated
Trial end date:
2020-12-22
Target enrollment:
Participant gender:
Summary
The growing consumer-grade molecular and digital wellness market is generating unprecedented
volumes of information to support decision-making around individual health. Current trends
suggest the demand for personalized health information, tools, and services will continue to
rise in the next decade. What is missing is a reliable, individualized way to turn this data
into action. Dialogue around consumer health often ignores the disconnect between
measurements and goals. For example, monitoring one's weight is not the same as losing
weight, and counting steps is not the same as lowering blood pressure. If individuals are to
benefit from data, they must be able to relate changes in their personal data to targeted
changes in actions and outcomes. There is a great need and opportunity to adapt the tools and
capabilities of modern computer science, statistics, and clinical trial design to the needs
of individual patients and consumers. The team at the Institute for Next Generation
Healthcare (INGH) has created a smartphone-based app ("N1 app") and study platform that
together allow individuals to design, implement, and analyze methodologically sound,
statistically robust studies of their personal health data. The focus of the platform will be
the creation of single-participant randomized crossover studies, known as n-of-1 trials. The
platform employs informatics-based intelligence that automates study design and analysis
while simultaneously maintaining high standards of statistical rigor and reproducibility.
These novel methods and tools are designed to empower individuals to make rational,
data-driven choices about their own health, maximizing the benefit all will receive from new
and existing sources of personal health data.