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

NCT07099612 | Completed DMC

• 1 other identifier: 18348
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer Study

Keywords

smart blister; medication intake; medication monitoring; adherence; digital health; medication compliance; self-management; patient behavior; usability; feasibility; user experience; System Usability Scale; mixed-methods; pilot

Outcome Measures

Primary Outcomes (2)

• System Usability Score (SUS)

  Usability of the smart blister system will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire measuring perceived ease of use, effectiveness, and satisfaction. Participants in both study arms will complete the SUS at the end of the 8-week study period. Units: Score from 0 to 100 (higher = better usability)

  Week 8 (end of study participation)

• Qualitative User Experience Feedback

  Participants will complete a semi-structured interview at the end of the study to explore their experience using the smart blister system, perceived usefulness, ease of integration into daily life, and suggestions for improvement. Transcripts will be analyzed thematically.

  Week 8

Secondary Outcomes (5)

• Medication Adherence (Digital Measurement)

  Cumulative over the 8-week study period

• Medication Adherence (Manual Pill Count)

  Week 8 (final visit)

• App Usage - Number of Blister Scans

  Cumulative over 8 weeks

• App Usage - Number of Manually Edited Doses

  Cumulative over 8 weeks

• App Usage - Days with App Interaction

  Cumulative over 8 weeks

Other Outcomes (1)

• Exploratory Subgroup Analyses of Usability (SUS) scores

  Week 8

Study Arms (2)

Smart Blister System + MEMS® Mobile App

EXPERIMENTAL

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.

Device: MEMS® Mobile smartphone application; Device: Cere®Pak smart blister pack

Smart Blister System Only (No App)

ACTIVE COMPARATOR

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.

Device: Cere®Pak smart blister pack

Interventions

MEMS® Mobile smartphone application 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.

Smart Blister System + MEMS® Mobile App

Cere®Pak smart blister pack 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 + MEMS® Mobile App; Smart Blister System Only (No App)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Aardex Group: collaborator
• Smurfit Westrock: collaborator

Study Sites (1)

University Medical Center Groningen (UMCG)

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Job F.M. van Boven, PharmD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study follows a parallel assignment design with two arms. Participants are randomly assigned to one of two groups in a 1:1 ratio at the start of the study and remain in their assigned group for the entire 8-week study period. Arm 1 (Intervention Group): Participants use the Cere®Pak smart blister system in combination with the MEMS® Mobile smartphone application. The app provides optional reminders, access to dosing history, and allows users to manually edit or confirm recorded dose events. Arm 2 (Control Group): Participants use the Cere®Pak smart blister system without the MEMS® Mobile app. This group receives no digital reminders or adherence feedback during the study.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: August 1, 2025
• Study Start: February 5, 2024
• Primary Completion: June 24, 2024
• Study Completion: July 22, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)