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

Keywords: Adherence; Glaucoma; MEMS; Medication Event Monitoring System; mHealth.

Figure 1

The CONNECTDROP connected MEMS (BIOCORP) for measuring treatment adherence in patients with glaucoma. The "add-on" (A) is configured to clip onto an ergonomic bottle of fixed combination dorzolamide/timolol (Easygrip, Laboratoires Théa) (B). The patient then uses the assembled system to deliver the prescribed dose of medication. The dotted lines and green triangle define the degree of angulation to the vertical required for a correct application technique (C).  = Bluetooth wireless connection. MEMS = Medication Event Monitoring System.

Figure 2

The CONDORE pilot timeline. Study participants attended the investigation center at baseline (week 0) and at the end of week 9 (or in the event of early withdrawal). Visit 2 was a phone consultation at which adherence and safety data were collected, and the patients reported their experience of changing the bottle. MEMS = Medication Event Monitoring System.

Figure 4

Participant flow diagram for the CONDORE pilot study. ITT = intention to treat.

Figure 5

Results of questions 1–3 (PQ.01–03) of the participant satisfaction questionnaire and question 1 (InQ.01) of the investigator satisfaction questionnaire. Responses have been collected using a 5-point Likert scale. The numbers displayed in the boxes are the absolute number of responses for each answer.

Figure 6

Results for participant satisfaction questionnaire question 11 (PQ.11), which asked respondents to circle one or more prepared statements on benefits associated with the App which they felt applied them. This question also allowed participants to provide a free text response to the PQ.11. Four responses were recorded, 3 of which are paraphrased here (the fourth was a duplicate of one of the 5 original statements).

Figure 9

Data matrix of the raw scores recorded by each connected device used over the 9-week trial period, to include a bottle change event on or around the end of week 8 (day 56). The overall adherence score for each device is calculated at the end of week 8. Opaque data points were recorded after week 9 and were not included in the analysis.

Figure 10

Data matrix of the complete scores recorded by each connected device used over the 9-week trial period, to include a bottle change event on or around the end of week 8 (day 56). The overall adherence score for each device is calculated at the end of week 8. Opaque data points were recorded after week 9 and were not included in the analysis.