Enhancing Medication Adherence With Mobili®: A Crossover Randomized Controlled Trial in Portuguese Community Pharmacies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Significant differences in medication adherence rates between the two groups (Objective)
研究概览
简要总结
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.
详细描述
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:
- Project management and dissemination;
- Training of participating pharmacists, and collection of feedback on adaptability to the Portuguese context, through focus groups prior to the implementation of the intervention;
- Assesing Mobili's efectiveness on medication adherence, through a randomized control trial (RCT) comparing Mobili users with a control group using existing DAAs;
- developing a protocol for a future large-scale study based on tasks 2 and 3 findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Significant differences in medication adherence rates between the two groups (Objective)
时间窗: 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
Significant differences in medication adherence rates between the two groups (Subjective)
时间窗: 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).
Significant differences in medication adherence rates between the two groups (Clinical markers)
时间窗: 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.
Significant differences in medication adherence rates between the two groups (Objective)
时间窗: 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
Significant differences in medication adherence rates between the two groups (Subjective)
时间窗: 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).
Significant differences in medication adherence rates between the two groups (Clinical markers)
时间窗: 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.
次要结局
- 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)
- 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)
研究者
João Pedro Bernardo Gregório
PI
Universidade Lusófona de Humanidades e Tecnologias