Testing a Smart Medication Dispenser (Mobili®) to Help People With Chronic Conditions Take Their Medicine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLusofona University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Independent use of the Mobili® Device by patients, overseen by pharmacists

    Device

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Mobili® device (Intervention Group)Experimental treatment 1 intervention
Group B: Placebo (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From recruitment to around 6 months after
2

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).

Time frame
From recruitment to around 6 months after
3

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.

Time frame
From recruitment to around 6 months after

Secondary outcomes

1

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.

Time frame
From recruitment until around 6 months after
2

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.

Time frame
From recruitment until 6 months after

Other outcomes

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: