Is CONNECTDROP®, a Medication Event Monitoring System Add-On Paired with a Smartphone Application, Acceptable to Patients with Glaucoma for Taking Their Daily Medication? The CONDORE Pilot Study

Abstract

ObjectiveThis pilot study tested the feasibility of a future efficacy trial examining the effect of CONNECTDROP®, a novel Medication Event Monitoring System (MEMS) paired with a mHealth application, on medication adherence in patients with glaucoma. DesignA single-center, single-arm, prospective interventional pilot study (NCT04552964) ParticipantsAdults with glaucoma managed with at least a fixed combination timolol/dorzolamide who are adherent to treatment. MethodsParticipants (n=31) were provided with the MEMS device and a smartphone with the Application installed. They were required to use the MEMS with their usual timolol/dorzolamide prescription for nine weeks. The study endpoint was at the end of week nine, when all study materials were returned, and participants completed a 17-item patient satisfaction questionnaire. Data collected continuously by each MEMS for the nine weeks was analyzed for its suitability to quantify adherence of the individual participant and characterize adherence trends within the study cohort. Clinical data were collected at baseline, week eight and week nine for the safety evaluation. Main outcome measuresThe primary outcome was global patient satisfaction after nine weeks. Secondary outcome measures included participant feedback on handling the MEMS and its usability, along with that of the connected Application. Objective data was used to determine participant medication adherence. The proportion of participants who successfully changed the MEMS to a new bottle at week eight was reported. ResultsThe MEMS-connected device achieved a global satisfaction score of 74.1% from study participants after nine weeks. Furthermore, 70.4 % of participants found the MEMS easy to use. However, only 59.2% reported feedback from the mHealth Application useful in reminding them to take their treatment. MEMS-derived data showed that 70.4% of participants achieved an "adherence score" of 80% or above after eight weeks and that 40.7% who completed the study had not changed the bottle correctly. No adverse events were reported. ConclusionIn this pilot study, the MEMS device had high satisfaction amongst this cohort of patients and was easy to use. The user satisfaction score for the Application was lower. The objective adherence data obtained appears reliable but must be validated for use in an efficacy trial.