Enhancing Medication Adherence With Mobili®: A Crossover Randomized Controlled Trial in Portuguese Community Pharmacies
Phase: NA
Conditions: Dose Administration Aids, Medication Adherence, Polypharmacy, Technology in Health, Diabetes, Cardiovascular Diseases
Sponsor: Lusofona University

 
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ENHANCING MEDICATION ADHERENCE WITH MOBILI®: 
A CROSSOVER RANDOMIZED CONTROLLED TRIAL IN 
PORTUGUESE COMMUNITY  
 
MobiMAd@PT RCT 
 
Lisbon, Portugal, August 26th 2025 
 
NCT Number: not yet assigned 
EudraCT number: not yet assigned 
 

Trial Protocol: Mobili® RCT 
Version 1.0 
Date of protocol commencement: 01-01-2025 
CBIOS 
Universidade Lusófona, Lisboa, Portugal 
 
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Enhancing Medication Adherence with Mobili®: A Crossover 
Randomized Controlled Trial in Portuguese Community 
Pharmacies 
 
 
 
Full Study Protocol 
 
 
 
 
 
 
Version 1.0 
 
August 26, 2025 
 
Research Center for Biosciences & Health Technologies (CBIOS) 
 
Universidade Lusófona, Lisboa, Portugal 
 
 
 

Trial Protocol: Mobili® RCT 
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TABLE OF CONTENTS 
ADMINISTRATIVE INFORMATION ................................................................................. 1 
1. BACKGROUND RATIONALE ......................................................................................... 2 
1.1 ABSTRACT .................................................................................................................... 2 
1.2 STATE OF THE ART .................................................................................................... 3 
1.3 OBJECTIVES ................................................................................................................ 5 
1.4 PROJECT OUTLINE ................................................................................................... 5 
2. METHODOLOGIES ........................................................................................................... 7 
2.1 TRIAL DESIGN ............................................................................................................. 7 
2.1.1 OBJECTIVES ........................................................................................................... 8 
2.2 PARTICIPANTS ............................................................................................................ 8 
2.2.1 ELIGIBILTY CRITERIA ......................................................................................... 8 
2.2.2 RECRUITMENT AND INFORMED CONSENT ................................................... 8 
2.4 TRIAL GROUPS ......................................................................................................... 10 
2.4.1 INTERVENTION GROUP ..................................................................................... 10 
2.4.2 CONTROL GROUP ............................................................................................... 10 
2.5 OUTCOMES ................................................................................................................ 10 
2.5.1. PRIMARY OUTCOME ......................................................................................... 10 
2.5.2 SECONDARY OUTCOMES ................................................................................. 10 
2.6 INTERVENTION ........................................................................................................ 11 
2.7 DATA MANAGEMENT .............................................................................................. 11 
3.1 APPROVALS ................................................................................................................ 12 
3.2 PARTICIPANT CONFIDENTIALITY ..................................................................... 12 
4. DECLARATION OF INTERESTS .................................................................................. 13 
5. FUNDING ........................................................................................................................... 13 
REFERENCES ....................................................................................................................... 14 
 
 
 
 
 

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LIST OF ABBREVIATIONS  
ADD: Automated Dose Dispensing 
AWS: Amazon Web Services 
BMQ: Beliefs about Medicines Questionnaire 
CBIOS: Center for Biosciences & Health Technologies 
DAA: Dose Administration Aids 
DHTTs: Digital Health Technology Tools  
DMP: Data Management Plan  
DRP: Drug Related Problems 
EQ-5D: EuroQol Five-Dimension Questionnaire 
FCT: Fundação para a Ciência e a Tecnologia 
GDPR: General Data Protection Regulation 
GP: General Practitioner 
MAD: Multidose Automated Dispensing 
MSQ: Medication Satisfaction Questionnaire 
NAS: Network Attached Storage 
RCT: Randomised Control Trial 
 
 
 
 
 
 
 
 
 
 

 
 
1 
ADMINISTRATIVE INFORMATION 
This protocol outlines the background, methodology, and ethical considerations of the trial 
titled “Enhancing Medication Adherence in Portugal: Implementation of Mobili®, an eHealth 
Medicine Dispensing Solution for multimorbidity Patients”. It has been prepared in accordance 
with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 
(Chan et al., 2025)  and the TIDieR (Better reporting of interventions: template for intervention 
description and replication) checklist and guide (Hoffmann et al., 2014). Administrative details 
of this trial are provided in Table 1, while the protocol revision history is documented in Table 
2. Any modifications to the trial procedures will be transparently reported and justified in an 
updated version of this protocol. 
 
Table 1 Administrative Information 
 
Open Science framework Page 
 
Trial Protocol Version 
1.0 
Date of Trial Protocol Commencement 
01.01.2025 
Date of Trial Start 
15.10.2025 
ClinicalTrials.gov Identifier 
 
Date of Trial Registration 
26.08.2025 
Contact Information 
mobimadpt@gmail.com 
Addendum Documents 
 
Appendixes 
 
 
Table 2 Trial Protocol Revision History 
Version 
Date of change 
Change(s) 
Justification 
1.0 
26th of August 
 
Finalising 
the 
document 
 
 

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1. BACKGROUND RATIONALE 
1.1 ABSTRACT 
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.  
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 delivery 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. 
 
 

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1.2 STATE OF THE ART 
Medication adherence refers to the extent to which patients take their prescribed 
medications as directed by their healthcare providers (Nieuwlaat et al., 2014). Prevalence of 
medication non-adherence can be as high as 50% (Foley et al., 2021), meaning that 1 in 2 
people do not take their medication as prescribed. Non-adherence to medication regimens can 
have significant consequences for patients, including decreased therapeutic effects and a 
significant impact on the sustainability of health systems (Cutler et al., 2018).  
Many determinants might affect medication adherence (Kardas et al., 2013). Moreover, 
multimorbidity (i.e. more than 2 chronic conditions per patient) and the associated 
polymedication (i.e more than 5 medications), also increase the likelihood of poor adherence 
(Maffoni et al., 2020). Recent evidence shows that up to a third of European patients aged 65 
and older are polymedicated (Midão et al., 2018).   
Remembering to take many medicines concomitantly, often several times daily is 
challenging and prone to errors. Therefore, community pharmacies are increasingly providing 
more medication adherence services (Martins et al., 2015), with overall positive evaluation and 
a high degree of patient satisfaction (Policarpo et al., 2019; Twigg et al., 2019). There is a wide 
array of successful DAA interventions to increase medication adherence implemented in the 
community pharmacy that have shown their effectiveness, but the heterogeneity of the type of 
interventions has hampered a definitive conclusion on their impact (Al-Arkee & Al-Ani, 2023; 
Wiecek et al., 2019). Most of these interventions are packaging and dosage modifications 
(either in single and manually prepared dosette boxes, or multidose automated dispensing 
systems) (Hersberger et al., 2013). In Portugal, the most prevalent DAA interventions are 
supported by manually filled dosette boxes and manually or automatically filled blisters 
(Vicente et al., 2021).  
The World Health Assembly recognized the value of digital technology to achieve the 
Sustainable Development Goals in its resolution on digital health in 2018 (WHO, 2021). Digital 
Health Technology Tools (DHTTs) have been touted as the next big leap in terms of health 
systems efficiency, supported by new medical devices, Artificial Intelligence, or even the 
combination of these two elements (Arora, 2020; Ayalew et al., 2022). The implementation of 
DHTTs is increasingly on the research agenda, since the gap between clinical validation and 
integration in the health system persists (Marwaha et al., 2022). Moreover, where DHTTs have 

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been implemented, the impact on equity brought by the digital divide is also a problem that 
must be addressed (Gregório et al., 2023).  
Lately, there has been an increased attention given to DHTTs developed to support 
pharmaceutical services and track real-time medication intake (Gregório et al., 2021; Patel et 
al., 2022). One of these DHTTs are Automated Dose Dispensing (ADD) robots. ADD robots 
are installed in patients' homes and autonomously provide medication without assistance from 
a caregiver, with the exception of refilling (Tahvanainen et al., 2021). Nevertheless, a major 
drawback is that the current ADD systems are cumbersome and non-portable. Portability is a 
leading specification of automatic medication dispensing systems, contributing to the patient 
centred aspect of these interventions (Aldeer et al., 2018; Mertz et al., 2021).  
Medthings®, a Norwegian start-up, has developed one fully portable ADD system - 
Mobili®. Beyond portability, Mobili® is integrated with a real-time monitoring system, 
transforming an otherwise high-tech reminder system into a complete eHealth system. Mobili® 
has two main components: the hard case, which contains the electronics and software, and the 
eDosette, where the medications are filled. This eDosette differs from traditional systems since 
it has a RFID chip that guarantees the medication is dispensed to the correct patient at the right 
time and can be re-used. Depending on the complexity of the therapeutic regimes, the eDosette 
provides patients with up to 28 opportunities for taking medicines. 
Implementing this project in Portugal, will allow to study Mobili’s effectiveness and 
adaptability to a different Health care system and setting. To do so, the project’s main aim is: 
To assess the effectiveness of Mobili® on medication adherence rates among chronic 
multimorbidity community dwelling patients in Portugal.  
The results of this project will provide valuable insights into the usefulness of Mobili®. 
The findings will inform the development and implementation of similar technologies and will 
contribute to the scientific knowledge about the implementation and impact of DHTTs in 
improving medication adherence and patient-centred care, critical factors for the sustainability 
of global health systems. 
Mobili® will be used in the context of a medication management service provided by 
community pharmacists. We hypothesize that multimorbidity patients will experience 
improved medication management and adherence. 

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1.3 OBJECTIVES 
This project has four main objectives: 
1. Assess the effectiveness of Mobili® on medication adherence rates among 
multimorbidity patients, compared to today’s systems and practices 
2. Assess the usability of Mobili® in a real-world setting, both by patients and healthcare 
professionals. 
3. Characterise Mobili®’s adaptability to a different Health care system and setting 
4. Develop a study protocol that can assess Mobili®’s impact in clinical, economic and 
humanistic outcomes in a future large-scale multi-centre project 
 
1.4 PROJECT OUTLINE 
To achieve the objectives stated above, the project has a detailed outline, divided in four 
distinct tasks.  
 
Task 1 – Project Management and Dissemination (Duration: 18 months) 
 
The Project Management task is longitudinal, through the duration of the project. Its 
aim is the overall management of the project to ensure the achievement of seven specific 
objectives: 
1. to provide a streamlined and efficient decision-making structure. 
2. to ensure the involvement of all consortium partners in decision-making. 
3. to provide a sound management and administration that will keep the project 
performing to schedule, quality and budget. 
4. to ensure transparent and efficient communication among the consortium 
partners, towards stakeholders. 
5. to coordinate the quality of results and deliverables including the adherence 
to the work plan, the project aim and contractual obligations and the management and 
supervision of the internal review processes. 
6. to provide a Data Management Plan for Data Governance, to be issued as 
deliverable in month 3 and updated as needed. 

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7. to communicate and disseminate results by disclosing them to the public by 
appropriate means, including (but not exclusively), in scientific publications and 
scientific communication conferences. 
 
 
Task 2 – Adaptation of Mobili® to the Portuguese Context (Duration: 4 months) 
This task focuses on adapting Mobili® for use in the new setting. Additionally, it aims 
to guarantee sufficient participant recruitment capabilities, and trained staff for an effective 
intervention.  
The task is divided in two sub-tasks. One sub-task will be dedicated to the training of 
pharmacists in the use of Mobili® and in the recruitment procedure and participant follow-up. 
On the other hand, the second sub-task will aim to gather pharmacists’ perceptions through a 
focus-group about internal and external factors that will impact the implementation of the 
intervention in the Portuguese setting, such as compatibility of Mobili® with existing 
workflows, the perceived advantages and challenges of using Mobili®, etc. 
 
Task 3 – Usability and Effectiveness Evaluation of Mobili® for Chronic Patients 
(Duration: 9 months) 
This task focuses on evaluating the usability and effectiveness of Mobili® in supporting 
medication management of non-institutionalized multimorbidity patients. To do so, a Parallel-
group, Staggered enrolment Randomised Control Trial (RCT) will be implemented, with 1:1 
allocation ratio.  
 
 
Task 4 – Development of a Study Protocol to Evaluate the Impact of the Mobili® System 
on Adherence to Therapy (Duration: 3 months) 
 
The aim of this task will be to develop a study protocol that allows the evaluation of 
the impact of Mobili® on adherence (primary endpoint), and other health indicators (secondary 
endpoint), in a large-scale multicentre RCT. Only after this potential prospective study is 
completed the evidence of the impact of Mobili® as an aid for medication adherence will be 
fully known. 
 
 

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2. METHODOLOGIES 
2.1 TRIAL DESIGN 
The study will employ a Parallel-group Crossover RCT design with a 1:1 allocation 
ratio, involving two arms: one intervention group using Mobili and one control group. The 
diagram presented below (figure 1) represents the path of participants in the RCT, evaluating 
the impact of Mobili® compared to usual DAA practice.  
 
 
Figure 1: RCT Study Protocol Scheme 
 
 

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2.1.1 OBJECTIVES 
Over a 9-month period, this task aims to assess the usability and effectiveness of 
Mobili® in supporting non-institutionalized chronic patients. 
The task will have two main aims: 
1. To assess the effectiveness of Mobili on medication adherence rates and 
disease management of chronic multimorbidity patients 
2. To evaluate Mobili usability for patients and pharmacists. 
 
2.2 PARTICIPANTS 
2.2.1 ELIGIBILTY CRITERIA 
Participants will be selected by pharmacists in the participant community pharmacies. 
These will be identified upon the presentation of a prescription and according to the following 
criteria:  
- 
non-institutionalised multimorbidity patients 
- 
aged ³18 years  
- 
requiring only regular oral medication that can be dispensed in the eDosette 
No limits as to the number of medications were set as exclusion criteria. However, the 
following exclusion criteria were applied: 
- 
one participant per household (either intervention or control group), to avoid 
confusion 
- 
cognitive impairments preventing independent use of Mobili® 
- 
patients using medication that does not fit or is incompatible with being 
dispensed in the eDosette (i.e. some capsules, solutions, insulins or GLP-1 
analogues, transdermal patches, eye-drops) 
2.2.2 RECRUITMENT AND INFORMED CONSENT 
Participants will be recruited from six community pharmacies, where a total of 20 
Mobili devices will be allocated. Potential participants will be identified when they visit the 

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pharmacy with a prescription for chronic-use medications. Those who meet the inclusion 
criteria will be invited to join the study. If they agree to participate, a type II medication review 
will be conducted by the pharmacists, followed by the completion of a baseline survey. After 
this, participants will be randomly assigned to one of the two study arms. 
Participants will receive both verbal and written information detailing their rights in 
relation to the research project, including information regarding their rights to retract their 
consent of study participation without justification and without any impact on their future care. 
The project coordinator will obtain the informed consent, ensuring that participants 
comprehend the information provided and that their participation is given freely and willingly. 
2.2.3 SAMPLE SIZE CALCULATION 
As this RCT is a pilot study, the sample size will be determined by the number of 
available Mobili® devices. Due to budget constraints, a limited number of Mobili® units 
will be allocated to the intervention group, as conﬁrmed by Medthings. To maximize the 
number of participants in the intervention group, a staggered enrollment strategy will be 
implemented. This approach is expected to allow for the inclusion of 96 participants. 
 
2.3 GROUP ALLOCATION 
Upon acceptance of the terms in the informed consent, an initial consultation with the 
pharmacist will be scheduled to collect all the baseline data. Participants will be subject to an 
initial screening of clinical parameters supporting a type II medication review (Foppe van Mil 
et al., 2016), aiming to ensure no Drug Related Problems (DRP), namely adverse drug 
reactions, are present. If such DRPs are detected, the pharmacist will contact the General 
Practitioner (GP) (or assistant physician) of the participant, and if the DRP cannot be resolved, 
the participant will be excluded from the study. Only after this procedure is complete the 
participant can be randomly assigned to either one of two arms.  
 

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2.4 TRIAL GROUPS  
2.4.1 INTERVENTION GROUP 
The intervention group will only be using Mobili® independently and overseen by 
pharmacists. Participants will receive the maximum number of eDosettes their therapeutic 
regime allows, to minimize visits to the pharmacy.  
2.4.2 CONTROL GROUP 
The control group will consist of participants using the Dose Administrating Aid 
intervention currently available in the participant pharmacies, which can be either manual 
dosette boxes or automatically filled blisters.  
 
2.5 OUTCOMES 
2.5.1. PRIMARY OUTCOME 
Medication adherence will be assessed using both objective and subjective measures. 
Objectively, adherence will be evaluated using the pill count method, while subjectively, it will 
be measured using a validated medication adherence scale. Additionally, clinical markers 
relevant to the prescribed medications, such as blood pressure for antihypertensive treatment, 
will be monitored to provide further insights into adherence. 
Expected results: Significant differences in medication adherence rates between the two 
groups. 
2.5.2 SECONDARY OUTCOMES 
Patient satisfaction and quality of life will be assessed through structured interviews 
with both patients and pharmacists at the beginning and end of the intervention. Instruments 
such as the EuroQol Five-Dimension Questionnaire (EQ-5D), the Medication Satisfaction 
Questionnaire (MSQ), and the Beliefs about Medicines Questionnaire (BMQ) are expected to 
be used. Additionally, a focus group with participating pharmacists will be conducted to gather 
further insights on how the service is integrated into the pharmacy workflow. Combining 
quantitative measures (e.g., medication adherence rates) with qualitative approaches (e.g., 
satisfaction interviews) enables a comprehensive evaluation. This mixed-methods approach 

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captures not only measurable outcomes but also the experiences and perceptions of patients 
and healthcare providers. 
Expected results: Enhanced patient satisfaction, reduced incidence of medication 
errors, and improved quality of life measures in the intervention group.  
 
2.6 INTERVENTION 
The intervention consists of the use of Mobili® by patients for a two-month period, with 
pharmacists providing initial training and ongoing support. A staggered enrolment scheme will 
allow for the rotation of Mobili® devices among participants to increase the sample size. 
Pharmacists will provide initial training and ongoing support to participants during the 
course of the intervention, either in person (e.g. when delivering the eDosette with the 
therapeutic regime), or via telephone. All the contacts made should be registered. The initial 
training and setup will take place in community pharmacies, with ongoing use in participants' 
homes. The duration, intensity, and frequency of interactions with the pharmacist will be 
registered, since the intervention will be personalized based on each participant’s medication 
regimen (i.e. can have a minimum of one interaction per month, or a maximum of one per 
week). The control group will consist of participants using the DAA intervention currently 
available in the participant pharmacies. 
Each participant in the intervention group will expectedly use the Mobili® during a 
minimum period of two-months. Due to the nature of this intervention and the determinants of 
adherence it tackles, such as: forgetfulness, complexity of regimens, and lack of motivation 
(Kardas et al., 2013). This period is considered enough to see changes in the medication 
adherence rate (Wiecek et al., 2019). During the duration of the study, the research team will 
visit the pharmacies monthly, tracking the progress of the study. 
 
2.7 DATA MANAGEMENT 
The Data Management Plan (DMP) will define the protocols for secure and compliant 
data handling throughout the project. All data will be stored on the CBIOS Network Attached 
Storage (NAS) at the Lusófona Data Center, which provides a secure and resilient infrastructure 
with built-in redundancy. Data transfers will be conducted via encrypted networks and secure 
cloud services that comply with applicable data protection regulations. The Mobili software, 

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which does not process any patient-identifiable information, and the MedThings application, 
hosted on Amazon Web Services (AWS), are both fully aligned with General Data Protection 
Regulation (GDPR) requirements. 
A designated Data Protection Officer will oversee compliance with data protection laws 
and ensure that robust data security measures are consistently applied. 
 
2.8 PROTOCOL AMENDMENTS 
Any modifications to trial procedures will be documented with the date of change and 
justification on our OSF page and ClinicalTrials.gov. If necessary, we will also seek ethical 
approval for these changes. 
 
3. ETHICS 
3.1 APPROVALS 
The trial will soon be presented before the local ethics committee and registered both 
on ClinicalTrials.gov and EudraCT.  
 
3.2 PARTICIPANT CONFIDENTIALITY 
Data collection will occur in three phases: baseline (medication adherence rates, 
demographics, health status, etc.), during the study (system usage monitoring), and post-study 
(medication adherence reassessment, patient satisfaction surveys, and qualitative interviews 
with pharmacists). The research team will not have access to any patient data, ensuring data 
privacy and patient security. Only the pharmacists will know patient details. 
Patients are identified in the Mobili® information system with a single ID number, that 
only pharmacists can cross-check with patient data. Pharmacy records of this study will be kept 
in paper, in a secured locker inside the pharmacy. All the data available for the research team 
for the purpose of the effectiveness evaluation will be anonymized.  
Data collection will be carried out through encrypted online platforms to ensure secure 
and anonymous entry. To safeguard confidentiality and maintain data integrity, all project data 

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will be both anonymized and encrypted. Access to the data will be limited through role-based 
permissions, and security will be further strengthened with regular audits and mandatory data 
protection training for all team members.  
 
4. DECLARATION OF INTERESTS 
The authors declare no conflict of interests. 
 
5. FUNDING 
This trial is funded by Fundação para a Ciência e a Tecnologia (FCT), as part of the 
Call for Exploratory Projects in All Scientific Domains 2023 (2023.11968.PEX). The funders 
have no roles in the study design, data collection, management, data analysis and interpretation, 
writing of the reports, or the decision to submit the reports for publication. 
 
 
 
 
 
 
 
 
 
 
 

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