RESUMO
BACKGROUND: Medication nonadherence is a major problem in health care, imposing poor clinical outcomes and a heavy financial burden on all stakeholders. Current methods of medication adherence assessment are severely limited: they are applied only periodically, do not relate to actual pill intake, and suffer from patient bias due to errors, misunderstanding, or intentional nonadherence. ReX is an innovative medication management system designed to address poor patient adherence and enhance patient engagement with their therapy. ReX controls and tracks pills from the point of packaging right through to the patient's mouth. ReX generates robust, real-time adherence data. The system enables patients to report outcomes, complete surveys, and receive messages and instructions. ReX includes a reusable drug dispensing unit, disposable cassette containing pills, and a cloud-based data portal. OBJECTIVE: We aimed to evaluate ReX feasibility by human factor studies including evaluation of ReX safety; ReX acceptance and usability; and ReX efficacy of providing pills according to a preprogrammed dose regimen, managing reminders and adherence data, and enhancing the adherence rate compared with the standard of care. METHODS: The ReX system was evaluated in 2 human factor, nonclinical feasibility studies. Human subjects used ReX for the administration of pill-shaped Tic Tac sweets. The initial study evaluated ReX use and pill intake administration; second was a self-controlled, 4-day home-use study. All subjects took pills at home, according to a preprogrammed dose regimen, for 4 days each via the device (ReX test) or from standard packaging (control test). The adherence rate (percent of pills taken) was measured by the study subject's report, remaining pills count, and ReX records (in the ReX test). ReX safety and usability were evaluated by a questionnaire filled out by the subject. RESULTS: The initial feasibility study evaluated usability and acceptance of the ReX novel approach to pill dispensing. All subjects successfully managed 2 pill intakes. The ReX device was rated as easy to use by 81% (48/59) of subjects. The 4-day home-use study evaluated the safety, efficacy, and usability of the ReX system. No adverse event occurred; no pill overdose or pill malformation was reported. The overall adherence rate in the ReX test was 97.6% compared with 76.3% in the control test (P<.001). Real-time, personalized reminders provided in the event of a delay in pill intake contributed to 18.0% of doses taken during the ReX test. The ReX system was found easy to use by 87% (35/40) of subjects; 90% (36/40) felt comfortable using it for their medication. CONCLUSIONS: ReX's novel "tracking to the mouth" technology was found usable and accepted by subjects. The assessment of adherence rates was reliable; adherence of subjects to the dose regimen was significantly enhanced when using ReX compared with the standard of care.