Monitoring Medication Adherence Using a Mobicontrol Application: A Case Study
Year of Publication
Hoehn, A; Yesko, L
Society for Clinical Trials (SCT) 37th Annual Meeting
Montreal, Quebec, Canada
Data Management; Electronic monitoring; Medication Adherence
The accurate measurement of medication adherence is critical to the success of pharmacotherapy clinical trials as imprecise measurement may lead to misleading study data and flawed interpretation of study data. Currently, no gold standard to monitor medication adherence exists and clinical trials employ a variety of methods to determine medication adherence, including participant recall, laboratory tests assessing biological markers, pill counts, prescription claims or refill data and electronic monitoring devices. These methods vary greatly in time, cost and complexity and each method presents unique challenges. This presentation will discuss the use of a MobiControl application to track participant adherence to study medication in a recent trial for the Clinical Trials Network (CTN) of the National Institute on Drug Abuse (NIDA). For this trial, participants received a cell phone preinstalled with a mobile device management system (i.e., MobiControl) which was used to securely store and transfer videos. On non-clinic visit days, participants were asked to record a video of themselves taking the oral study medication and transfer the encrypted file to study staff using the MobiControl application. Receipt of video recordings was recorded on a Dose Log and adherence to oral study medication was assessed through in-clinic observation of self-administration as well as through these home video recordings. Participants received compensation only for medication doses observed in clinic and doses recorded at home. The benefits and risks of utilizing a MobiControl will be discussed, including the technical and regulatory challenges encountered and the elements required to make it successful. The effect of the MobiControl on study retention and on participant drug use will also be examined.