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

Objective

This 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.

Design

A single-center, single-arm, prospective interventional pilot study (NCT04552964).

Participants

Adults with glaucoma managed with at least a fixed combination of timolol/dorzolamide who are adherent to treatment.

Methods

Participants (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 9 weeks. The study endpoint was at the end of week 9, when all study materials were returned, and participants completed a 17-item patient satisfaction questionnaire. Data collected continuously by each MEMS for the 9 weeks were analyzed for their suitability to quantify adherence of the individual participant and characterize adherence trends within the study cohort. Clinical data were collected at baseline, week 8, and week 9 for the safety evaluation.

Main Outcome Measures

The primary outcome was global patient satisfaction after 9 weeks. Secondary outcome measures included participant feedback on handling the MEMS and its usability, along with that of the connected application. Objective data were used to determine participant medication adherence. The proportion of participants who successfully changed the MEMS to a new bottle at week 8 was reported.

Results

The MEMS-connected device achieved a global satisfaction score of 74.1% from study participants after 9 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 8 weeks and that 40.7% who completed the study had not changed the bottle correctly. No adverse events (AEs) were reported.

Conclusion

In this pilot study, the CONNECTDROP device was able to monitor daily intake of anti-glaucomatous medication over 2 months and had high satisfaction amongst this cohort of patients and was easy to use. The objective adherence data obtained appears reliable but must be validated for use in an efficacy trial.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.