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Personalized Drug Treatment of Frail Patients: Integrated Care and Real-Time Home Monitoring
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Summary
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.
Official title: Personalized Pharmacological Treatment of the Frail Patient: Integrated CARE and Real-Time Monitoring at Home (FRAIL-CARE).
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-24
Completion Date
2026-06-30
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Healthcare device
CE-marked medical device software (patient mobile app, clinical web app with real-time dashboard and alerts) integrated with the Checkme Pro portable device, which records temperature, heart rate, oxygen saturation, blood pressure, ECG, sleep and steps. Used by patient and caregiver at home for 6 months after discharge; data are reviewed by the Operations Centres.
Remote monitoring by Specialist Operations Centres
Case managers (COS1, working days 8:00-16:00) check the dashboard daily, contact patients after alerts or alarm symptoms and call every patient at least weekly to administer clinical questionnaires. The Poison Control Centre of Pavia (COS2) answers urgent calls outside these hours, 24/7
Blood drug concentration monitoring beyond routine TDM
Measurement of blood concentrations of drugs prescribed at discharge and not covered by routine therapeutic drug monitoring, on a blood sample of up to 3 mL, at discharge, 3 months, 6 months and whenever an adverse reaction, toxicity, inefficacy or interaction is suspected. Samples can be taken at home with a courier kit.
Locations (3)
ICS Maugeri Spa-SB - Istituto di Milano IRCCS Camaldoli
Milan, MI, Italy
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, PV, Italy
ICS Maugeri Spa-SB - Istituto di Tradate IRCCS
Tradate, VA, Italy