OBJECTIVES: Electronic monitoring adherence devices (EAMDs) are increasingly being used to measure adherence across many healthcare settings. The objective of this study is to validate the performance parameters of a novel EAMD, Sensal Health Smart Dock ^TM, specifically the time of dose dispensed, the number of doses dispensed, and the specific user dispensing doses.

METHODS: This validation study simulated patients withdrawing medications (Tic-Tac) from the device against reference documentation via MS Forms. Three users completed a 4-day study consisting of 2 non-consecutive 1-hour sessions encompassing 6 pulls from the pill bottles to be captured by the Sensal Health Smart Dock ^TM. Statistical analysis included percent agreement and Cohen’s Kappa assessing agreement between user-reported data and electronic measurement data recorded by the Smart Dock ^TM. Outcome measures included confirmation of the specific user, time of dose removal (± 1 minute), and the number of pills withdrawn. The study protocol was approved by the University of Houston Investigational Review Board.

RESULTS: Three subjects were recruited with informed consent providing a total of 144 actuations. The study found perfect 100% agreement across the number of pills dispensed and specific users dispensing pills and 99% agreement for the time of administration. Cohen’s kappa measures for the three respective outcome measures were 1.00 (95% CI [1.00, 1.00] indicating perfect agreement, and 0.993 95% CI [0.990, 0.996] indicating near perfect agreement.

CONCLUSIONS: This study found that the Sensal Health Smart Dock ^TM can accurately record the time of administration, number of pills dispensed, and identity of the user dispensing pills. The Sensal Health Smart Dock ^TM is a valuable option when precisely tracking medication dispensing quantity and the identity of the dispenser is of clinical and operational value and further larger-scale studies are needed in real-world settings.