Dose Administration AidsMobiMAd@PT RCTNCT07175545
Testing a Smart Medication Dispenser (Mobili®) to Help People With Chronic Conditions Take Their Medicine
A study testing Independent use of the Mobili® Device by patients, overseen by pharmacists in people with Dose Administration Aids and Medication Adherence, run by Lusofona University at 1 site in Portugal.
Trial summary
Medication adherence is one of the biggest challenges faced by healthcare systems, especially among people with multiple chronic diseases who take several medications daily. Studies show that up to half of patients do not take their medication as prescribed, which can compromise treatment effectiveness, increase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dose Administration Aids, Medication Adherence, Polypharmacy
- What is being tested?
- Independent use of the Mobili® Device by patients, overseen by pharmacists
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and above
- Non-institutionalized diabetes and cardiovascular disease patients
- At least two medications in the therapeutic regimen
- Requiring only regular oral medication that can be dispensed in the eDosette
- Able to handle the use of technological devices (i.e. smartphones)
Who cannot join
- Cognitive impairments preventing independent use of Mobili®
- Patients using medicines that do not fit or are incompatible with being dispensed in the eDosette (i.e. some capsules, solutions, insulins or GLP-1 analogues, transdermal patches, eye-drops)
- One participant per household
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Universidade Lusófona - Centro Universitário de Lisboa
Lisbon, 1749-024
Luís M Rodrigues, +351217515500 ext. 629, monteiro.rodrigues@ulusofona.pt
About this study
Official title: Enhancing Medication Adherence With Mobili®: A Crossover Randomized Controlled Trial in Portuguese Community Pharmacies
Medication adherence is one of the biggest challenges faced by healthcare systems, especially among people with multiple chronic diseases who take several medications daily. Studies show that up to half of patients do not take their medication as prescribed, which can compromise treatment effectiveness, increase complications, and lead to waste of healthcare resources.
In this context, several solutions have been developed to help patients organize their therapy, such as dose administration aids (DAAs) used in pharmacies. However, many of these systems are manual, inflexible, or difficult to use.
Read more
This study is part of the MobiMAd@PT project, which will evaluate Mobili®, a portable digital medication dispenser developed in Norway. Mobili® allows patients to automatically receive the right medication at the right time and comes with a real-time monitoring system, enabling healthcare professionals to detect missed doses and provide timely support.
The main goal of this study is to assess the effectiveness of Mobili® in improving medication adherence among patients with polypharmacy in Portugal and to understand whether this type of technology can be useful and applicable in the context of Portuguese community pharmacies. Your participation will contribute to the development of new ways to manage health at home, with the support of pharmacists and technology.
Read the detailed description
Medication non-adherence is a critical challenge for global health systems, with evidence suggesting that up to half of patients may not follow their prescribed medication. Given the rates of medication non-adherence and its detrimental effects on health outcomes and health systems sustainability, numerous Dose Administration Aids (DAA) interventions have been developed. Most of them are packaging and dosage modifications, either in single and manually prepared dosette boxes, or in multidose automated dispensing (MAD) systems, prepared in community or hospital pharmacies. However, in spite of their success, most MAD are cumbersome and lack long-term sustainability.
In an era where digital health technologies are reshaping healthcare delivery, this project introduces Mobili® in Portugal, a portable MAD system developed by the Norwegian start-up Medthings. Mobili combines portability, automated dose dispensing and real-time monitoring, facilitating a more manageable medication regimen for chronic patients.
This research project aims to explore the effectiveness of Mobili on medication adherence among chronic multimorbidity patients and its adaptability in a different health system. Achieving these aims will provide valuable insights into the deployment of technology-driven interventions in actual healthcare settings, potentially transforming digital adherence solutions for chronic patients. The CFIR 2.0 Implementation Research framework will guide the development of the research tasks.
The project comprises four tasks:
- Project management and dissemination;
- Training of participating pharmacists, and collection of feedback on adaptability to the Portuguese context, through focus groups prior to the implementation of the intervention;
- Assesing Mobili's efectiveness on medication adherence, through a randomized control trial (RCT) comparing Mobili users with a control group using existing DAAs;
- developing a protocol for a future large-scale study based on tasks 2 and 3 findings.
Task 3 will also assess secondary outcomes like patient satisfaction and quality of life through interviews, using both quantitative and qualitative methods for a comprehensive intervention evaluation. The insights gained during this project will lay the groundwork for a detailed study protocol to fully assess Mobili's effectiveness in enhancing medication adherence across Europe.
This project's findings will contribute to better understand the impact of digital health interventions on medication adherence, patients' health and healthcare systems' efficiency, and will be valuable to researchers in medication adherence and implementation science. The project also holds substantial scientific and commercial potential, through:
- the deliver of a research protocol for a large-scale study to assess Mobili's clinical and economic value to European health systems
- initial insights into a disruptive DAA service business model.
The successful real-world application of the project's outcomes could enhance medication adherence and patient management, promoting a culture of adherence within the community, significantly improving care quality and generating economic benefits for patients and health systems.
The project's success strategy centers on three pillars:
- leveraging the diverse expertise and experience within the team, with a strong support and commitment from the manufacturer of Mobili;
- integrating Design Science with participatory action research to enhance stakeholder engagement;
- establishing a core management team to enable a strong collaboration between scientific and clinical expertise, through regular project meetings.
The multidisciplinary research team, comprising experts in pharmaceutical services innovation, information system research, health communication, and organizational development, brings a wealth of experience from previous studies in pharmacy services, healthcare management, and digital medication adherence tools.
- Conditions
- Dose Administration Aids, Medication Adherence, Polypharmacy, Technology in Health, Diabetes, Cardiovascular Diseases
- Being tested
- Independent use of the Mobili® Device by patients, overseen by pharmacists
- Keywords
- Digital Health, Medication Adherence, Automatic Medicine Dispenser, Community Pharmacy
- Medical subject headings
- Medication Adherence, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Independent use of the Mobili® Device by patients, overseen by pharmacistsDevice
After recruitment each participant will be subject to a type I medication review.
After allocation to the intervention group, pharmacists will provide initial training to participants, and during the course of the intervention whenever necessary (e.g. when delivering the eDosette with the therapeutic regime). Pharmacists will prepare the eDosette in the pharmacy and deliver it directly to participants with no further intervention.
Participants will receive the number of eDosettes their therapeutic regime allows, to minimize visits to the pharmacy. For the control group, pharmacists will also provide the number of DAAs the therapeutic regime allows. Upon finishing the intervention, a new type II medication review will be performed for all participants (intervention and control) and information related to their personal therapeutic regime will be provided, ensuring a safe exit of the study.
| Study group | Role | What they receive |
|---|---|---|
| Mobili® device (Intervention Group) | Experimental | Group of patients using the Mobili® device Receives: Device: Independent use of the Mobili® Device by patients, overseen by pharmacists |
| Placebo (Control Group) | No intervention | Group of patients using the current Dose Administration Aid system available in the pharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant differences in medication adherence rates between the two groups (Objective)
Medication adherence rates will be measured objectively by the Pill count method, analysing how many pills are taken or forgotten by the participants
Measured: From recruitment to around 6 months after
Significant differences in medication adherence rates between the two groups (Subjective)
Medication adherence rates will be measured subjectively by a validated medication adherence scale, using tools such as the Medical Adherence Questionnaire (MAQ) - a self-reporting instruments to measure how well patients follow their prescribed treatment regimens. Instruments like these help identify barriers to adherence, assessing adherence levels (low, medium, high).
Measured: From recruitment to around 6 months after
Significant differences in medication adherence rates between the two groups (Clinical markers)
Monitoring clinical markers that indicate whether a medication is likely being taken, such as glycemic and arterial pressure levels, will provide additional information on adherence.
Measured: From recruitment to around 6 months after
Secondary outcomes (2)
Enhanced patient satisfaction, reduced incidence of medication errors, and improved quality of life measures in the intervention group
Patient satisfaction and quality of life measures will be measured through structured interviews with participants (both pharmacists and patients) at the start and at the end of the intervention. It is expected to use instruments such as the EuroQol Five-Dimension Questionnaire (EQ-5D) - system measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - and similar.
Measured: From recruitment until around 6 months after
Influence on the pharmacy's workflow
There will also be a focus group with the participant pharmacists to collect additional information regarding the service integration into the pharmacy workflow.
Measured: From recruitment until 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dose Administration AidsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lusofona University
- Sponsor type
- University, hospital or other
- Collaborators
- CBIOS - Research Center for Biosciences & Health Technologies, MedThings, Associação Nacional das Farmácias, University of Oslo, Universidade de Trás-os-Montes e Alto Douro, GHTM - Global Health and Tropical Medicine, COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal)
- Responsible party
- Principal investigator, João Pedro Bernardo Gregório, Universidade Lusófona de Humanidades e Tecnologias
- Investigators
- João Pedro B Gregório, PharmD PhD, Principal investigator, COFAC - Cooperativa Cooperativa de Animação e Formação Cultural, C.R.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175545
- Sponsor's protocol ID
- LusofonaU
- Other IDs
- 2023.11968.PEX, 2023
- Acronym
- MobiMAd@PT RCT
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality issues, the sharing of patient data will always be subject to request
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Medication Adherence With Mobili®: A Crossover Randomized Controlled Trial in Portuguese Community Pharmacies
- ClinicalTrials.gov ID
- NCT07175545
- Acronym / sponsor ID
- MobiMAd@PT RCT / LusofonaU
- Conditions
- Dose Administration Aids, Medication Adherence, Polypharmacy, Technology in Health, Diabetes, Cardiovascular Diseases
- Keywords
- Digital Health, Medication Adherence, Automatic Medicine Dispenser, Community Pharmacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Lusofona UniversityUniversity, hospital or other
- Collaborators
- CBIOS - Research Center for Biosciences & Health Technologies, MedThings, Associação Nacional das Farmácias, University of Oslo, Universidade de Trás-os-Montes e Alto Douro, GHTM - Global Health and Tropical Medicine, COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal)
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Sep 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.
Medication adherence is one of the biggest challenges faced by healthcare systems, especially among people with multiple chronic diseases who take several medications daily. Studies show that up to half of patients do not take their medication as prescribed, which can compromise treatment effectiveness, increase complications, and lead to waste of healthcare resources.
In this context, several solutions have been developed to help patients organize their therapy, such as dose administration aids (DAAs) used in pharmacies. However, many of these systems are manual, inflexible, or difficult to use.
This study is part of the MobiMAd@PT project, which will evaluate Mobili®, a portable digital medication dispenser developed in Norway. Mobili® allows patients to automatically receive the right medication at the right time and comes with a real-time monitoring system, enabling healthcare professionals to detect missed doses and provide timely support.
The main goal of this study is to assess the effectiveness of Mobili® in improving medication adherence among patients with polypharmacy in Portugal and to understand whether this type of technology can be useful and applicable in the context of Portuguese community pharmacies. Your participation will contribute to the development of new ways to manage health at home, with the support of pharmacists and technology.
Detailed description
Medication non-adherence is a critical challenge for global health systems, with evidence suggesting that up to half of patients may not follow their prescribed medication. Given the rates of medication non-adherence and its detrimental effects on health outcomes and health systems sustainability, numerous Dose Administration Aids (DAA) interventions have been developed. Most of them are packaging and dosage modifications, either in single and manually prepared dosette boxes, or in multidose automated dispensing (MAD) systems, prepared in community or hospital pharmacies. However, in spite of their success, most MAD are cumbersome and lack long-term sustainability.
In an era where digital health technologies are reshaping healthcare delivery, this project introduces Mobili® in Portugal, a portable MAD system developed by the Norwegian start-up Medthings. Mobili combines portability, automated dose dispensing and real-time monitoring, facilitating a more manageable medication regimen for chronic patients.
This research project aims to explore the effectiveness of Mobili on medication adherence among chronic multimorbidity patients and its adaptability in a different health system. Achieving these aims will provide valuable insights into the deployment of technology-driven interventions in actual healthcare settings, potentially transforming digital adherence solutions for chronic patients. The CFIR 2.0 Implementation Research framework will guide the development of the research tasks.
The project comprises four tasks:
- Project management and dissemination;
- Training of participating pharmacists, and collection of feedback on adaptability to the Portuguese context, through focus groups prior to the implementation of the intervention;
- Assesing Mobili's efectiveness on medication adherence, through a randomized control trial (RCT) comparing Mobili users with a control group using existing DAAs;
- developing a protocol for a future large-scale study based on tasks 2 and 3 findings.
Task 3 will also assess secondary outcomes like patient satisfaction and quality of life through interviews, using both quantitative and qualitative methods for a comprehensive intervention evaluation. The insights gained during this project will lay the groundwork for a detailed study protocol to fully assess Mobili's effectiveness in enhancing medication adherence across Europe.
This project's findings will contribute to better understand the impact of digital health interventions on medication adherence, patients' health and healthcare systems' efficiency, and will be valuable to researchers in medication adherence and implementation science. The project also holds substantial scientific and commercial potential, through:
- the deliver of a research protocol for a large-scale study to assess Mobili's clinical and economic value to European health systems
- initial insights into a disruptive DAA service business model.
The successful real-world application of the project's outcomes could enhance medication adherence and patient management, promoting a culture of adherence within the community, significantly improving care quality and generating economic benefits for patients and health systems.
The project's success strategy centers on three pillars:
- leveraging the diverse expertise and experience within the team, with a strong support and commitment from the manufacturer of Mobili;
- integrating Design Science with participatory action research to enhance stakeholder engagement;
- establishing a core management team to enable a strong collaboration between scientific and clinical expertise, through regular project meetings.
The multidisciplinary research team, comprising experts in pharmaceutical services innovation, information system research, health communication, and organizational development, brings a wealth of experience from previous studies in pharmacy services, healthcare management, and digital medication adherence tools.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobili® device (Intervention Group) | Experimental | Device: Independent use of the Mobili® Device by patients, overseen by pharmacistsGroup of patients using the Mobili® device |
| Placebo (Control Group) | No intervention | –Group of patients using the current Dose Administration Aid system available in the pharmacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years and above
- Non-institutionalized diabetes and cardiovascular disease patients
- At least two medications in the therapeutic regimen
- Requiring only regular oral medication that can be dispensed in the eDosette
- Able to handle the use of technological devices (i.e. smartphones)
Key exclusion criteria (3 listed)
- Cognitive impairments preventing independent use of Mobili®
- Patients using medicines that do not fit or are incompatible with being dispensed in the eDosette (i.e. some capsules, solutions, insulins or GLP-1 analogues, transdermal patches, eye-drops)
- One participant per household
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 |
|---|---|---|
| Independent use of the Mobili® Device by patients, overseen by pharmacistsAfter recruitment each participant will be subject to a type I medication review. After allocation to the intervention group, pharmacists will provide initial training to participants, and during the course of the intervention whenever necessary (e.g. when delivering the eDosette with the therapeutic regime). Pharmacists will prepare the eDosette in the pharmacy and deliver it directly to participants with no further intervention. Participants will receive the number of eDosettes their therapeutic regime allows, to minimize visits to the pharmacy. For the control group, pharmacists will also provide the number of DAAs the therapeutic regime allows. Upon finishing the intervention, a new type II medication review will be performed for all participants (intervention and control) and information related to their personal therapeutic regime will be provided, ensuring a safe exit of the study. | Device | Mobili® device (Intervention Group) |
Primary outcome
Significant differences in medication adherence rates between the two groups (Objective)
Time frame: From recruitment to around 6 months after
Medication adherence rates will be measured objectively by the Pill count method, analysing how many pills are taken or forgotten by the participants
Significant differences in medication adherence rates between the two groups (Subjective)
Time frame: From recruitment to around 6 months after
Medication adherence rates will be measured subjectively by a validated medication adherence scale, using tools such as the Medical Adherence Questionnaire (MAQ) - a self-reporting instruments to measure how well patients follow their prescribed treatment regimens. Instruments like these help identify barriers to adherence, assessing adherence levels (low, medium, high).
Significant differences in medication adherence rates between the two groups (Clinical markers)
Time frame: From recruitment to around 6 months after
Monitoring clinical markers that indicate whether a medication is likely being taken, such as glycemic and arterial pressure levels, will provide additional information on adherence.
2 secondary outcomes
Enhanced patient satisfaction, reduced incidence of medication errors, and improved quality of life measures in the intervention group
Time frame: From recruitment until around 6 months after
Influence on the pharmacy's workflow
Time frame: From recruitment until 6 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to patient confidentiality issues, the sharing of patient data will always be subject to request
Related trials for Dose Administration Aids
RecruitingPhase 1
Study of GS-0415 and How It Works in People With HIV
HIV -1 Infection
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
HIV Infections
Not yet recruitingPhase 2
bNAbs and Anti-PD-1 in HIV
HIV-1
Recruiting
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Early Syphilis, Latent, Serological Relapse After Treatment
RecruitingPhase 2
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
HIV Infections
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.
João Pedro B Gregório, PharmD PhD principal investigator
COFAC - Cooperativa Cooperativa de Animação e Formação Cultural, C.R.L
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Independent use of the Mobili® Device by patients, overseen by pharmacists in people with Dose Administration Aids and Medication Adherence, run by Lusofona University at 1 site in Portugal.
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: opening soon, as of the sponsor's last update on 16 Sep 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact João Pedro B Gregório, PharmD PhD (+351217515500, joao.gregorio@ulusofona.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant differences in medication adherence rates between the two groups (Objective) (time frame: From recruitment to around 6 months after). The study lists 3 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 16 Sep 2025.