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.