Universidade Lusófona - Centro Universitário de Lisboa
Lisbon, 1749-024, Portugal
NCT Number: NCT07175545
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Lisbon, 1749-024, Portugal
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:
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 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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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).
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.
Time frame: From recruitment until around 6 months after
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.
Time frame: From recruitment until 6 months after
There will also be a focus group with the participant pharmacists to collect additional information regarding the service integration into the pharmacy workflow.
Contact information is provided by the study sponsor or research team.
Lusofona University
Other
Enhancing Medication Adherence With Mobili®: A Crossover Randomized Controlled Trial in Portuguese Community Pharmacies
Acronym: MobiMAd@PT RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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