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

NCT ID: NCT07099612

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-07-22

Brief 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.

Detailed Description

This randomized controlled pilot study investigates the usability and feasibility of the Cere®Pak smart blister system, with and without integration of the MEMS® Mobile smartphone application, in healthy adult volunteers. The study evaluates whether the addition of a mobile app improves the user experience and adherence behavior compared to the use of the smart blister pack alone.

Cere®Pak is an electronic blister system that automatically logs the date and time of each dose dispensed. The MEMS® Mobile app connects with the blister pack via near-field communication (NFC), enabling users to receive reminders, view their adherence data, and manually edit dosing events if needed. The app is compatible with iOS and Android smartphones and allows users to activate or deactivate features such as notifications and data visualization.

Participants are randomized in a 1:1 ratio into two parallel arms:

• Intervention Group (Arm 1): participants use the Cere®Pak system in combination with the MEMS® Mobile app.
• Control Group (Arm 2): participants use the Cere®Pak system without app support (i.e., no reminders or adherence feedback).

The study runs over an 8-week period. Participants receive four 28-count placebo blister packs, simulating a twice-daily medication regimen. They are instructed to push out tablets at the designated times, but not to ingest them. Data on blister openings are recorded electronically. App users are instructed to scan the pack regularly to synchronize data.

Primary outcomes include: The System usability, assessed via the System Usability Scale (SUS), a 10-item validated questionnaire. Additionally, qualitative user feedback collected via semi-structured interviews.

Secondary outcomes include: Medication adherence based on electronic records (raw and adjusted for technical malfunctions). Secondly, adherence verification via manual pill counts at the end of the follow-up period. Finally, app usage data (e.g., scan frequency, use of editing function, reminder engagement).

The study also includes technical performance monitoring. Device malfunctions (e.g., battery failures, sensor disconnection) are logged and excluded from adherence calculations when relevant.

This trial uses a mixed-methods approach to evaluate both objective outcomes and subjective user experience. The results will inform future implementation of smart medication packaging systems and the role of app-based feedback in promoting adherence.

Conditions

Healthy Volunteer Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Smart Blister System + MEMS® Mobile App

Participants in this group will use the Cere®Pak smart blister system in combination with the MEMS® Mobile smartphone application. The app connects to the blister pack via near-field communication (NFC) and provides optional reminder notifications, visual feedback on adherence history, and the ability to manually edit or confirm dose events. Participants will use the system for 8 weeks, following a simulated twice-daily medication schedule using placebo tablets. Tablets are not ingested. Adherence data is recorded electronically and synchronized through the app.

Group Type: EXPERIMENTAL

MEMS® Mobile smartphone application

Intervention Type: DEVICE

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.

Cere®Pak smart blister pack

Intervention Type: DEVICE

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.

Smart Blister System Only (No App)

Participants in this group will use the Cere®Pak smart blister system without access to the MEMS® Mobile app or its features. The smart blister electronically records tablet removal, but participants do not receive reminders or adherence feedback. They will follow the same 8-week, twice-daily placebo schedule as the intervention group. Tablets are not ingested. This group serves as a control to assess the added value of the app in terms of usability and adherence.

Group Type: ACTIVE_COMPARATOR

Cere®Pak smart blister pack

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Able to read and understand English
• Owns a compatible smartphone (iOS version ≥13 or Android version ≥8)
• Willing and able to use a smart blister pack system for 8 weeks
• Provides informed consent

Exclusion Criteria

• Severe physical or cognitive limitations that interfere with the use of blister packaging or smartphone apps
• Known allergy or sensitivity to the materials in the blister packaging (even though tablets are not ingested)
• Serious health conditions that significantly limit daily functioning

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aardex Group

UNKNOWN

Sponsor Role: collaborator

Smurfit Westrock

UNKNOWN

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Job F.M. van Boven, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The Netherlands

Locations

University Medical Center Groningen (UMCG)

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

18348

Identifier Type: -

Identifier Source: org_study_id