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Sample Size Calculations for Micro-randomized Trials in mHealth #MMPMID26707831
Liao P; Klasnja P; Tewari A; Murphy SA
Stat Med 2016[May]; 35 (12): 1944-71 PMID26707831show ga
The use and development of mobile interventions are experiencing rapid growth. In ?just-in-time? mobile interventions, treatments are provided via a mobile device and they are intended to help an individual make healthy decisions ?in the moment,? and thus have a proximal, near future impact. Currently the development of mobile interventions is proceeding at a much faster pace than that of associated data science methods. A first step toward developing data-based methods is to provide an experimental design for testing the proximal effects of these just-in-time treatments. In this paper, we propose a ?micro-randomized? trial design for this purpose. In a micro-randomized trial, treatments are sequentially randomized throughout the conduct of the study, with the result that each participant may be randomized at the 100s or 1000s of occasions at which a treatment might be provided. Further, we develop a test statistic for assessing the proximal effect of a treatment as well as an associated sample size calculator. We conduct simulation evaluations of the sample size calculator in various settings. Rules of thumb that might be used in designing a micro-randomized trial are discussed. This work is motivated by our collaboration on the HeartSteps mobile application designed to increase physical activity.