Clinical Research Directory

Personalized Drug Treatment of Frail Patients: Integrated Care and Real-Time Home Monitoring

FRAIL-CARE is a prospective, multicentre, non-profit, low-intervention pilot feasibility study conducted in four Maugeri Scientific Clinical Institutes (IRCCS) in Lombardy, Italy. It will enrol 40 frail patients older than 65 years who take five or more drugs every day and are discharged home from cardiac, neurological or pulmonary rehabilitation, oncology or internal medicine units. After discharge, patients and their caregivers use a CE-marked digital health solution made of a smartphone app, a portable connected monitoring device and a clinician dashboard. Remote Specialist Operations Centres (COS), staffed by trained case managers, follow symptoms, vital signs and alerts and call patients at least once a week. The Poison Control Centre of Pavia acts as the emergency centre outside COS hours, for urgent clinical questions, drug interactions and treatment changes. In addition, blood concentrations of prescribed drugs that are not usually covered by therapeutic drug monitoring are measured at discharge, at 3 and 6 months, and whenever an adverse reaction, lack of efficacy or interaction is suspected. The main aim is to evaluate the impact of this integrated home care model on quality of life (EQ-5D-5L). Secondary aims are to assess usability and acceptability of the technology (System Usability Scale), adherence to therapy (MARS-5), early detection of critical clinical events and potentially toxic drug levels, and the number of dropouts. Each patient is followed for 6 months. The results will provide a basis for welfare policies supporting frail patients.

Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers

Why are the researchers doing this study? Many older adults take five or more medicines every day. Some of these medicines may no longer help them. Some may even cause harm, such as falls, confusion or tiredness. At the same time, a medicine the person needs may be missing. The researchers want to find out whether a careful review of a person's medicines helps older adults stay well. They will look at intrinsic capacity. This means the physical and mental abilities a person can draw on: memory and thinking, walking and moving, eating well, mood, eyesight and hearing. They will also look at quality of life, daily life, health and social conditions. This kind of study has not been done before in primary health care centers in Lebanon. Who can take part? You may be able to join if you: * are 65 years old or older * have been a patient at one of the health centers for at least one year * take five or more medicines for long-term health problems * can carry out your daily activities on your own What will happen in the study? About 452 people will join at the primary health care centers of the Order of Malta Lebanon. A computer will place each person in one of two groups, by chance, like the toss of a coin. About half (226 people) will be in each group: * In the first group, a pharmacist will go through all of the person's medicines. The pharmacist will use tools made for checking medicines in older people. The pharmacist will then send suggestions to the person's doctor. The doctor decides what to change. No medicine is changed without the doctor's agreement. * In the second group, people will keep taking the medicines their doctor already prescribed. These medicines are checked in the usual way, which is the same for all patients. They are not checked with tools made for older people. The study does not test any new or experimental medicine. Every month, when the person comes to pick up their medicines, the pharmacist will check the medicine list. The pharmacist will write down any change and any problem the person reports. The researchers will check the person's abilities three times: at the start, after three months, and after six months. They will also ask about quality of life, health and social conditions at the start and after six months. Each person takes part for six months. What are the possible risks and benefits? In both groups, a person's medicines may change during the study. A medicine may be added, stopped or replaced after a review. Medicines can cause new problems, such as side effects. This can happen with a new medicine. It can also happen with a medicine the person has taken for a long time. The pharmacist asks about such problems every month. Any change to a person's medicines is decided by their own doctor, as in normal care. People in the study may or may not feel better. The researchers hope the results will help care for older people in Lebanon and in other countries. What happens after the study? People in both groups keep receiving the usual care of their health center. Taking part does not change a person's right to care. Joining is a free choice. A person can stop at any time, and their care will not change.

Home-based Monitoring & Enabled Medication Independence With New Digital Tools

This clinical trial is studying an online tool that may help older adults safely manage their medications at home. The study focuses on older adults who live alone and have memory concerns or mild changes in thinking. Many people in this group take several medications, which can make it hard to keep track of when and how to take them, notice side effects, or know when to ask for help. In this study, participants use an online self-monitoring platform to record any problems, symptoms, or concerns they have while taking their medications. The platform also provides helpful education and suggestions for managing medications and symptoms. Participants can share summaries from the platform with their health care team, which may help improve communication and support. The goal of the study is to see whether this tool can help older adults feel more confident, informed, and prepared to manage their medications safely while living at home.

Factors Determining the Rate of Adoption of Pharmaceutical Recommendations by Patients in Primary Care Following a Medication Review by a Pharmacist

Polypharmacy is a growing public health concern associated with adverse drug events, drug interactions, and hospitalizations. Medication reviews (MedRev) are structured evaluations of patients' medications aiming to optimize treatment and improve outcomes. In Belgium, a reimbursed MedRev service involving community pharmacists and general practitioners (GPs) has been implemented since 2023. The RevMedAdopt Pharmacy Study is a national prospective interventional study evaluating the real-world implementation of pharmaceutical recommendations generated during medication reviews performed by supervised final-year pharmacy students. The primary objective is to assess the adoption rate of pharmaceutical recommendations at 3 and 6 months after the medication review. Recommendations are categorized as fully adopted, partially adopted, not adopted, or unavailable. Secondary objectives are to identify factors associated with recommendation implementation, including patient characteristics, pharmacist and GP collaboration, medication review processes, and recommendation-related factors. The study includes adult polymedicated patients living at home in Belgium and followed by both a GP and a reference pharmacist. Approximately 120 patients will be recruited. Medication reviews are conducted during pharmacy internships following the official Belgian MedRev framework. Recommendations validated by supervising pharmacists are communicated to GPs. Follow-up data are collected through telephone interviews with patients and GPs. Qualitative interviews with patients, pharmacists, and GPs explore barriers and facilitators influencing recommendation adoption. This mixed-methods study aims to improve understanding of the implementation of pharmacist-led medication review recommendations in primary care and to support optimization of interprofessional collaboration and medication review services.