Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT07099612
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2025-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smart Blister Packaging and Mobile Application to Monitor and Support Medication Adherence: a Two-arm Usability Study
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Usability and Feasibility of a Smart Blister System With and Without a Mobile App: A Mixed-Methods Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-BLISTER
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: