Healthy Volunteer StudySMART-BLISTERNCT07099612
Smart Blister Packaging and Mobile Application to Monitor and Support Medication Adherence: a Two-arm Usability Study
A study testing MEMS® Mobile smartphone application and Cere®Pak smart blister pack in people with Healthy Volunteer Study, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- MEMS® Mobile smartphone application and Cere®Pak smart blister pack
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2024to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen (UMCG)
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Usability and Feasibility of a Smart Blister System With and Without a Mobile App: A Mixed-Methods Study
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.
Read more
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.
Read the 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
- Being tested
- MEMS® Mobile smartphone application, Cere®Pak smart blister pack
- 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
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMS® Mobile smartphone applicationDevice
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 packDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cere®Pak smart blister pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Week 8
Secondary outcomes (5)
Medication Adherence (Digital Measurement)
Medication adherence will be calculated as the proportion of scheduled doses registered by the smart blister system. Days with device malfunction will be excluded from analysis. Adherence will be expressed as the percentage of recorded doses versus expected doses over 8 weeks. Units: Percentage (%).
Measured: Cumulative over the 8-week study period
Medication Adherence (Manual Pill Count)
Adherence will also be assessed through manual pill counts of returned blister packs at the final study visit. The number of tablets removed will be compared to the expected number over the 8-week study period. Units: Number of tablets taken / Percentage (% adherence)
Measured: Week 8 (final visit)
App Usage - Number of Blister Scans
Total number of times the participant scanned the blister pack using the MEMS® Mobile app. Unit: Count (n)
Measured: Cumulative over 8 weeks
App Usage - Number of Manually Edited Doses
Total number of doses that were manually edited or confirmed by the participant. Unit: Count (n)
Measured: Cumulative over 8 weeks
App Usage - Days with App Interaction
Description: Number of days during the 8-week study period on which the participant interacted with the app. Unit: Number of Days
Measured: Cumulative over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start5 Feb 2024
- Primary completion24 Jun 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Aardex Group, Smurfit Westrock
- Responsible party
- Sponsor
- Investigators
- Job F.M. van Boven, PharmD, PhD, Principal investigator, Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099612
- Sponsor's protocol ID
- 18348
- Acronym
- SMART-BLISTER
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data (IPD) due to the small sample size, the non-clinical nature of the data, and privacy considerations. The study was conducted as a pilot usability evaluation, and the primary outcomes do not involve sensitive health data or clinical endpoints. While individual-level data may be made available upon reasonable request in the future, there is no formal data sharing plan in place at this time.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Feasibility of a Smart Blister System With and Without a Mobile App: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07099612
- Acronym / sponsor ID
- SMART-BLISTER / 18348
- Conditions
- Healthy Volunteer Study
- Keywords
- smart blister, medication intake, medication monitoring, adherence, digital health, medication compliance, self-management, patient behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Aardex Group, Smurfit Westrock
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smart Blister System + MEMS® Mobile App | Experimental | Device: MEMS® Mobile smartphone application, Device: Cere®Pak smart blister packParticipants 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. |
| Smart Blister System Only (No App) | Active comparator | Device: Cere®Pak smart blister packParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEMS® Mobile smartphone applicationThe 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 | Smart Blister System + MEMS® Mobile App |
| Cere®Pak smart blister packThe 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. | Device | Smart Blister System + MEMS® Mobile App, Smart Blister System Only (No App) |
Primary outcome
System Usability Score (SUS)
Time frame: Week 8 (end of study participation)
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)
Qualitative User Experience Feedback
Time frame: Week 8
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.
5 secondary outcomes
Medication Adherence (Digital Measurement)
Time frame: Cumulative over the 8-week study period
Medication Adherence (Manual Pill Count)
Time frame: Week 8 (final visit)
App Usage - Number of Blister Scans
Time frame: Cumulative over 8 weeks
App Usage - Number of Manually Edited Doses
Time frame: Cumulative over 8 weeks
App Usage - Days with App Interaction
Time frame: Cumulative over 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data (IPD) due to the small sample size, the non-clinical nature of the data, and privacy considerations. The study was conducted as a pilot usability evaluation, and the primary outcomes do not involve sensitive health data or clinical endpoints. While individual-level data may be made available upon reasonable request in the future, there is no formal data sharing plan in place at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Job F.M. van Boven, PharmD, PhD principal investigator
Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEMS® Mobile smartphone application and Cere®Pak smart blister pack in people with Healthy Volunteer Study, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Score (SUS) (time frame: Week 8 (end of study participation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.