Smart blisters to monitor and support medication adherence: a usability study (SMART BLISTER)

A novel medication event monitoring system (MEMS®) has been developed in the form of a smart blister package (Electronic DosePak, EPD®). This study will aims to investigate usability of the MEMS EDP® smart blister system for use in trials at the University Medical Center Groningen and beyond.
We propose a pragmatic trial examining the acceptance and technical robustness of the MEMS EDP system. We will include 20 healthy volunteers (English speaking) with diverse age/sex/education.

The key objectives of this study:

• Perform analysis and validation of the MEMS EDP’s robustness, accuracy and patient acceptance within a clinical study
• Initial investigation of benefits to health professionals and subjects when the MEMS EDP is used to support, measure, and monitor dispensing of medicines

In order for the MEMS EPD to be used with patients taking medicines, we intend to show that the system is simple for patients to use, collects accurate data, performs as intended for the life of a trial and supports patients to better manage their medicines.

Subjects will have one digital meeting and two site visits:
• Prior to visit 1, all subjects will attend a (digital) general kick-off meeting with information on the study and have training on how to use the EDP.
• At Visit 1, they will receive the EPD in person (or by mail post if applicable).
• At Visit 2, they will return the blisters with a short one to one interview and are reminded to complete the online questionnaires (in English).

All participants receive four MEMS EDP's containing 14 placebo tablets per blister. The placebo tablets are taken out twice daily (not intended to be ingested). The follow-up period is four weeks.