Smart Blister Packaging and Mobile Application to Monitor and Support Medication Adherence: a Two-arm Usability Study

Summary

Many people struggle to take their medications as prescribed, which can lead to poor health outcomes and increased healthcare costs. New technologies, such as smart blister packs and mobile apps, may help patients improve how they take their medicine. These systems can record when a tablet is taken and give reminders or feedback through a smartphone.

This study evaluates the usability and feasibility of a smart medication packaging system called Cere®Pak, which automatically logs each time a tablet is removed. A connected mobile application, MEMS® Mobile, can provide additional support such as reminders and dose tracking.

The goal of this study is to compare the user experience of the Cere®Pak system with and without the use of the app. We hypothesize that participants using the app in addition to the smart blister will report better usability and may show higher engagement with the system.

The study is a small, randomized trial involving healthy adult volunteers. Participants are randomly assigned to one of two groups: One group uses the Cere®Pak system together with the MEMS® Mobile app, which includes optional reminders and access to adherence data. The other group uses the Cere®Pak system alone, without the app or digital feedback.

Participants are asked to simulate taking a placebo tablet twice daily for eight weeks by pushing tablets out of the blister pack (without ingesting them). The study measures usability through questionnaires, medication-taking behavior through electronic monitoring and pill counts, and collects feedback through short interviews.

This study will help determine how acceptable and usable this technology is, and whether the mobile app adds value in supporting consistent medication use.

Conditions

• Healthy Volunteer Study

Interventions

DEVICE

MEMS® Mobile smartphone application

The MEMS® Mobile app is a smartphone application that connects to the Cere®Pak smart blister pack via near-field communication (NFC). It allows participants to view their medication intake history, receive optional reminders, and manually edit or confirm recorded dosing events. The app is installed on the participant's own smartphone (iOS or Android) and used throughout the 8-week study period. Participants are encouraged to scan their blister at least once daily to synchronize data. This intervention is for the Arm 1 group only.

DEVICE

Cere®Pak smart blister pack

The Cere®Pak is an electronic blister pack with 28 cavities containing placebo tablets. It automatically records the date and time when each cavity is opened, using embedded electronics. Participants are instructed to simulate a twice-daily medication schedule (morning and evening) for 8 weeks by pushing out tablets without ingesting them. The device functions independently in the control group and connects with the MEMS® Mobile app in the intervention group. Both arms work with this intervention.

Sponsors & Collaborators

• Aardex Group

  collaborator UNKNOWN

• Smurfit Westrock

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Job F.M. van Boven, PharmD, PhD · Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2024-06-24

Completion

2024-07-22

Countries

• Netherlands

Study Locations