Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 23, 2019
Open Peer Review Period: Oct 1, 2019 - Oct 9, 2019
Date Accepted: Dec 3, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Striking the Right Balance: a protocol to evaluate factors associated with completion and adherence in app-based n-of-1 trials
ABSTRACT
Background:
N-of-1 trials promise to help individuals make more informed decisions about treatment selection through structured experiments that compare treatment effectiveness by alternating treatments and measuring their impacts in a single individual. We created a digital platform that automates the design, administration, and analysis of n-of-1 trials. Our first n-of-1 trial, the app-based Brain Boost Study, invites individuals to compare the impacts of two commonly consumed substances, caffeine and L-theanine, on their cognitive performance.
Objective:
The purpose of this study is to evaluate key factors that may impact completion of n-of-1 trials in order to inform the design of future app-based n-of-1 trials. We will measure study completion rates for participants that begin the Brain Boost Study and assess their associations with study duration (5, 15, or 27 days), notification level (light or moderate), and self-assessed motivation level to learn individual results (5-point Likert scale). We will also evaluate the usability of the N1 app.
Methods:
Participants will be randomized into 3 study durations and 2 notification levels. In order to sufficiently power the study, 640 individuals must begin the study and 97 individuals must complete the study. We will use a Bayesian multiple logistic regression model to discern whether the study length, notification level, and self-reported motivation level are associated with the rate of study completion. For each group, we will also compare participant adherence and the proportion of trials that yield statistically meaningful results.
Results:
We have completed beta-testing of the N1 app on a convenience sample of users. The Brain Boost Study on the N1 app plans to open enrollment to the public in the fall of 2019.
Conclusions:
To our knowledge, this will be the first study to rigorously evaluate key factors associated with study completion in the context of app-based N-of-1 trials. Clinical Trial: ClinicalTrials.gov NCT04056650
Citation
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Copyright
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