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

NCT07175545 | Not Yet Recruiting DMC

• 2 other identifiers: LusofonaU2023.11968.PEX
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dose Administration Aids; Medication Adherence; Polypharmacy; Technology in Health; Diabetes; Cardiovascular Diseases

Keywords

Digital Health; Medication Adherence; Automatic Medicine Dispenser; Community Pharmacy

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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.

  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

  From recruitment until around 6 months after

• Influence on the pharmacy's workflow

  From recruitment until 6 months after

Study Arms (2)

Mobili® device (Intervention Group)

EXPERIMENTAL

Group of patients using the Mobili® device

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

Interventions

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.

Mobili® device (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lusofona University: lead
• 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

Study Sites (1)

Universidade Lusófona - Centro Universitário de Lisboa

Lisbon, 1749-024, Portugal

Location

Related Links

• Project Website

MeSH Terms

Conditions

Medication Adherence; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• João Pedro B Gregório, PharmD PhD

  COFAC - Cooperativa Cooperativa de Animação e Formação Cultural, C.R.L

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Pedro B Gregório, PharmD PhD

CONTACT

+351217515500; joao.gregorio@ulusofona.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: October 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)