About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Crossover
Treatments tested in this trial
Independent use of the Mobili® Device by patients, overseen by pharmacists
DeviceAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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).
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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Lusofona University
Lead sponsor
Universidade Lusófona de Humanidades e Tecnologias
Sponsor institution
CBIOS - Research Center for Biosciences & Health Technologies
Collaborator
MedThings
Collaborator
Associação Nacional das Farmácias
Collaborator
University of Oslo
Collaborator
Universidade de Trás-os-Montes e Alto Douro
Collaborator
GHTM - Global Health and Tropical Medicine
Collaborator
COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: