Abstract
BACKGROUND: Electronic monitoring adherence devices (EAMDs) are increasingly being utilized in various healthcare settings to track medication adherence. OBJECTIVE: To determine the accuracy of the Sensal Health MyAide™ Smart Doc in capturing dose removal from the vial, specifically the time of dose removal and the number of pills removed for each actuation of the device. METHODS: This validation study compares the device's recording of dose withdrawals from a prescription vial by simulated patients against reference documentation reported using MS Forms by the participants. Three participants completed a 4-day study consisting of two non-consecutive 1 h sessions per day encompassing six actuations from the prescription vial to be captured by the Sensal Health MyAide™ Smart Dock after their informed consent was obtained. Statistical analysis included percent agreement and Cohen's kappa assessing agreement between user-reported data and electronic measurement data recorded by the MyAide™ Smart Dock. Outcome measures included confirmation of the specific user, time of dose removal (±1 min), and the number of pills withdrawn. RESULTS: Three subjects were recruited to provide data for a total of 144 actuations. The study found perfect 100% agreement across the number of pills withdrawn and specific users withdrawing the pills and 99% agreement for the time of administration. The Cohen's kappa values for the outcome measures were 1.00 (95%CI [1.00, 1.00]) for the number of pills dispensed and specific user and 0.993 (95%CI [0.990, 0.996]) for the time of administration. CONCLUSIONS: This study found that the Sensal Health MyAide™ Smart Dock can accurately record the time of administration, the number of pills dispensed, and the identity of the user dispensing the pills.