An interventional study of Healthcare device and Remote monitoring by Specialist Operations Centres in Frailty, Polypharmacy (People Under Treatment With 5 or More Drugs) and Multimorbidity, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 3 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Health services research
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.
Background. Frailty is a complex clinical condition with reduced ability to respond to stress, often associated with multimorbidity and disability. In Italy about 17% of people are considered frail, rising to 34% among those over 85. After hospital discharge, frail patients are exposed to polypharmacy (five or more drugs), with a higher risk of drug interactions, adverse drug reactions and poor adherence. Many drugs used in these patients are not included in routine therapeutic drug monitoring (TDM), which makes treatment optimisation difficult. Families carry a heavy care burden, and territorial care is often fragmented.
Rationale. FRAIL-CARE tests an integrated model of home care that combines remote clinical follow-up, digital tools and personalised drug monitoring. The model rests on three pillars:
Setting. Rehabilitation, oncology and internal medicine units of the Maugeri IRCCS in Pavia (Oncology, General Medicine, Cardiac Rehabilitation), Milano Camaldoli (Neurological Rehabilitation, ALS), Tradate and Lumezzane (Pulmonary Rehabilitation). The Toxicology unit of Pavia does not enrol patients but provides the Poison Control Centre and the laboratory. Healthcare staff are trained in a one-day course, then train their teams.
Participants. 40 patients older than 65 years with a stable caregiver, frailty (Clinical Frailty Scale 4 or higher; Edmonton Frail Scale 10 or higher for neurological patients), chronic polypharmacy (five or more drugs a day), a main discharge diagnosis among heart failure, severe asthma, COPD, Parkinson disease stage III-V, other severe neurological disease (e.g. stroke), cancer or metabolic disease, a smartphone, and the ability to give informed consent. Patients with significant cognitive impairment who cannot manage the technology, or without a caregiver willing to follow the project, are excluded. The first 40 consenting patients are enrolled at discharge.
Procedures. At enrolment (T0) eligibility is checked, consent is obtained, baseline data are collected in the case report form, devices and app are provided with training for patient and caregiver, the first drug levels are drawn, and the System Usability Scale and EQ-5D-5L are administered. From T0 to 6 months patients use the technology and receive weekly active telephone follow-ups. At T1 (3 months) and T2 (6 months) drug levels, therapy adjustments, usability (SUS), adherence (MARS-5) and quality of life (EQ-5D-5L) are recorded.
Statistics. The sample size was chosen for feasibility, not on statistical grounds, so the study is a pilot and any inferential result is exploratory. Descriptive statistics (mean and standard deviation, or median and interquartile range; frequencies and percentages) are used for cross-sectional data. Longitudinal data are analysed with paired Student t tests or non-parametric equivalents for pre-post comparisons, and repeated-measures analysis of variance or non-parametric equivalents when there are three or more measurements.
Data and ethics. Each unit collects and stores its data under a unique alphanumeric patient code. Study documents are kept for seven years. The study is approved by the Comitato Etico Territoriale Lombardia 6 and follows Good Clinical Practice and the GDPR. It is funded by Fondazione Cariplo through a competitive call.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's enrollment of 40 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Frail patients older than 65 years with polypharmacy discharged home. For 6 months they use the RiAtlas Healthcare app and Checkme Pro device, are followed remotely by Specialist Operations Centres (weekly calls, alerts, 24/7 urgent support), and have blood levels of prescribed drugs measured at discharge, 3 and 6 months and when clinically needed.
Device: Healthcare device · Other: Remote monitoring by Specialist Operations Centres · Diagnostic Test: Blood drug concentration monitoring beyond routine TDM
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.
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
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.
Change in health-related quality of life (EQ-5D-5L)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The questionnaire evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.For each dimension, patients select one of five response options, ranging from no problems to extreme problems or inability to perform the activity. Higher levels of reported problems indicate worse health status. The questionnaire also includes a self-rated health scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better perceived health. Assessments are performed at enrolment (T0), 3 months (T1), and 6 months (T2)
Time frame: Baseline (T0), 3 months (T1) and 6 months (T2)
Usability of the technological solution (System Usability Scale)
Usability assessed using the System Usability Scale (SUS), a 10-item questionnaire completed by patients and caregivers. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability of the technological solution.
Time frame: Baseline (T0), 3 months (T1) and 6 months (T2)
Adherence to therapy (MARS-5)
Medication adherence assessed using the Medication Adherence Report Scale (MARS-5), a 5-item questionnaire. The total score ranges from 5 to 25, with higher scores indicating better medication adherence.
Time frame: 3 months (T1) and 6 months (T2)
Number of critical clinical events intercepted
Medication adherence assessed using the Medication Adherence Report Scale (MARS-5), a 5-item questionnaire. The total score ranges from 5 to 25, with higher scores indicating better medication adherence.
Time frame: From enrolment to 6 months
Number of potentially dangerous events detected by drug level measurement
Events found through blood drug concentrations that led to corrective interventions (e.g. toxic levels, interactions, inefficacy).
Time frame: From enrolment to 6 months
Blood drug levels
Measurement of blood concentrations of selected medications prescribed at hospital discharge, expressed in μg/L, at baseline, 3 and 6 months after enrolment, and whenever clinically necessary.
Time frame: Baseline, 3 months and 6 months
Plan to share: No
Ran from Sep 2025 to primary completion in Jun 2026, 9 months.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 9 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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