FrailtyFRAIL-CARENCT07903584
Personalized Drug Treatment of Frail Patients: Integrated Care and Real-Time Home Monitoring
A study testing Healthcare device, Remote monitoring by Specialist Operations Centres and Blood drug concentration monitoring beyond routine TDM in people with Frailty and Polypharmacy (People Under Treatment With 5 or More Drugs), run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Polypharmacy (People Under Treatment With 5 or More Drugs), Multimorbidity
- What is being tested?
- Healthcare device, Remote monitoring by Specialist Operations Centres and Blood drug concentration monitoring beyond routine TDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesItaly
- Study dates
- 24 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age older than 65 years
- Presence of a stable caregiver
- Frailty: Clinical Frailty Scale score of 4 or higher (cardiac, pulmonary, oncology and internal medicine patients) or Edmonton Frail Scale score of 10 or higher (neurological patients)
- Chronic polypharmacy: intake of 5 or more drugs per day
- Main diagnosis at discharge of at least one of: heart failure, severe or very severe bronchial asthma, chronic obstructive pulmonary disease (COPD), Parkinson disease Hoehn and Yahr stage III-V, other severe neurological disease (e.g. stroke), cancer or metabolic disease
- Availability of a smartphone (iOS or Android)
- Ability to understand and give informed consent
Who cannot join
- Significant cognitive impairment that may make it difficult to use the technological tools, together with unavailability of the caregiver to follow the project
- Unavailability of the caregiver to follow the project
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ICS Maugeri Spa-SB - Istituto di Milano IRCCS Camaldoli
Milan, MI, 20138
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, PV, 27100
ICS Maugeri Spa-SB - Istituto di Tradate IRCCS
Tradate, VA, 21049
About this study
Official title: Personalized Pharmacological Treatment of the Frail Patient: Integrated CARE and Real-Time Monitoring at Home (FRAIL-CARE).
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.
Read the detailed description
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:
- Technological solution: RiAtlas Healthcare (medical device software registered with the Italian Ministry of Health, repertory number 2111804), with a patient mobile app for symptom reporting, vital signs, reminders and therapy prompts, and a clinical web app with a real-time dashboard and alerts. It is integrated with the Checkme Pro portable device (repertory number 2056594; blood pressure accessory repertory number 1967409), which records temperature, heart rate, oxygen saturation, blood pressure, ECG, sleep and steps.
- Specialist Operations Centres (COS): three COS1 centres (Pavia, Tradate, Milano Camaldoli), run by dedicated case managers on working days from 8:00 to 16:00, check the dashboard daily, contact patients when alerts or alarm symptoms appear, and call every patient at least weekly to administer clinical questionnaires. Outside these hours the Poison Control Centre of Pavia (COS2) provides 24/7 urgent medical support. After a clinical assessment, the intervention may be home management (including drug suspension or administration), referral to emergency services, or an outpatient re-evaluation.
- Analytical drug monitoring: blood concentrations of drugs chosen by the treating physician among those prescribed at discharge (antipsychotics, antiepileptics, antidepressants, benzodiazepines, antiarrhythmics, beta-blockers, calcium antagonists, antibiotics, direct oral anticoagulants, antifungals, chemotherapeutics, immunosuppressants, antiasthmatics, metformin) are measured in the Clinical and Experimental Toxicology laboratory of IRCCS Pavia on a blood sample of at most 3 mL. Samples are taken at discharge, at 3 and 6 months, and whenever an adverse reaction, toxicity, inefficacy or interaction is suspected. A kit and a courier allow sampling at home. Tests are free of charge for participants.
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.
- Being tested
- Healthcare device, Remote monitoring by Specialist Operations Centres, Blood drug concentration monitoring beyond routine TDM
- Keywords
- frailty, polypharmacy, remote monitoring, telemonitoring, therapeutic drug monitoring, digital health, integrated care, caregivers, medication adherence, quality of life
- Medical subject headings
- Frailty, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare deviceDevice
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 CentresOther
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 TDMDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| FRAIL-CARE integrated home care | Experimental | 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. Receives: Device: Healthcare device; Other: Remote monitoring by Specialist Operations Centres; Diagnostic Test: Blood drug concentration monitoring beyond routine TDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (T0), 3 months (T1) and 6 months (T2)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start24 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same integrated home care model (digital monitoring, Specialist Operations Centres, blood drug level monitoring) and are followed for 6 months.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903584
- Sponsor's protocol ID
- FRAIL-CARE
- Acronym
- FRAIL-CARE
- Status last verified
- Nov 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
The Lancet Regional Health-Europe. Securing the future of Europe's ageing population by 2050. Lancet Reg Health Eur. 2023 Dec 1;35:100807. doi: 10.1016/j.lanepe.2023.100807. eCollection 2023 Dec. No abstract available.
PubMed 38115962Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.
PubMed 15372591Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing. 2006 Sep;35(5):526-9. doi: 10.1093/ageing/afl041. Epub 2006 Jun 6. No abstract available.
PubMed 16757522Theou O, Perez-Zepeda MU, van der Valk AM, Searle SD, Howlett SE, Rockwood K. A classification tree to assist with routine scoring of the Clinical Frailty Scale. Age Ageing. 2021 Jun 28;50(4):1406-1411. doi: 10.1093/ageing/afab006.
PubMed 33605412Swartz K, Collins LG. Caregiver Care. Am Fam Physician. 2019 Jun 1;99(11):699-706.
PubMed 31150177Laatikainen O, Sneck S, Turpeinen M. Medication-related adverse events in health care-what have we learned? A narrative overview of the current knowledge. Eur J Clin Pharmacol. 2022 Feb;78(2):159-170. doi: 10.1007/s00228-021-03213-x. Epub 2021 Oct 6.
PubMed 34611721Petrovic M, van der Cammen T, Onder G. Adverse drug reactions in older people: detection and prevention. Drugs Aging. 2012 Jun 1;29(6):453-62. doi: 10.2165/11631760-000000000-00000.
PubMed 22642780Franceschi M, Scarcelli C, Niro V, Seripa D, Pazienza AM, Pepe G, Colusso AM, Pacilli L, Pilotto A. Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit: a prospective study of 1756 patients. Drug Saf. 2008;31(6):545-56. doi: 10.2165/00002018-200831060-00009.
PubMed 18484788Lea M, Rognan SE, Koristovic R, Wyller TB, Molden E. Severity and management of drug-drug interactions in acute geriatric patients. Drugs Aging. 2013 Sep;30(9):721-7. doi: 10.1007/s40266-013-0091-y.
PubMed 23681400Bergman H, Ferrucci L, Guralnik J, Hogan DB, Hummel S, Karunananthan S, Wolfson C. Frailty: an emerging research and clinical paradigm--issues and controversies. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):731-7. doi: 10.1093/gerona/62.7.731.
PubMed 17634320
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Pharmacological Treatment of the Frail Patient: Integrated CARE and Real-Time Monitoring at Home (FRAIL-CARE).
- ClinicalTrials.gov ID
- NCT07903584
- Acronym / sponsor ID
- FRAIL-CARE / FRAIL-CARE
- Keywords
- frailty, polypharmacy, remote monitoring, telemonitoring, therapeutic drug monitoring, digital health, integrated care, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Technological solution: RiAtlas Healthcare (medical device software registered with the Italian Ministry of Health, repertory number 2111804), with a patient mobile app for symptom reporting, vital signs, reminders and therapy prompts, and a clinical web app with a real-time dashboard and alerts. It is integrated with the Checkme Pro portable device (repertory number 2056594; blood pressure accessory repertory number 1967409), which records temperature, heart rate, oxygen saturation, blood pressure, ECG, sleep and steps.
- Specialist Operations Centres (COS): three COS1 centres (Pavia, Tradate, Milano Camaldoli), run by dedicated case managers on working days from 8:00 to 16:00, check the dashboard daily, contact patients when alerts or alarm symptoms appear, and call every patient at least weekly to administer clinical questionnaires. Outside these hours the Poison Control Centre of Pavia (COS2) provides 24/7 urgent medical support. After a clinical assessment, the intervention may be home management (including drug suspension or administration), referral to emergency services, or an outpatient re-evaluation.
- Analytical drug monitoring: blood concentrations of drugs chosen by the treating physician among those prescribed at discharge (antipsychotics, antiepileptics, antidepressants, benzodiazepines, antiarrhythmics, beta-blockers, calcium antagonists, antibiotics, direct oral anticoagulants, antifungals, chemotherapeutics, immunosuppressants, antiasthmatics, metformin) are measured in the Clinical and Experimental Toxicology laboratory of IRCCS Pavia on a blood sample of at most 3 mL. Samples are taken at discharge, at 3 and 6 months, and whenever an adverse reaction, toxicity, inefficacy or interaction is suspected. A kit and a courier allow sampling at home. Tests are free of charge for participants.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same integrated home care model (digital monitoring, Specialist Operations Centres, blood drug level monitoring) and are followed for 6 months.
| Arm | Type | Receives |
|---|---|---|
| FRAIL-CARE integrated home care | Experimental | Device: Healthcare device, Other: Remote monitoring by Specialist Operations Centres, Diagnostic Test: Blood drug concentration monitoring beyond routine TDMFrail 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age older than 65 years
- Presence of a stable caregiver
- Frailty: Clinical Frailty Scale score of 4 or higher (cardiac, pulmonary, oncology and internal medicine patients) or Edmonton Frail Scale score of 10 or higher (neurological patients)
- Chronic polypharmacy: intake of 5 or more drugs per day
- Main diagnosis at discharge of at least one of: heart failure, severe or very severe bronchial asthma, chronic obstructive pulmonary disease (COPD), Parkinson disease Hoehn and Yahr stage III-V, other severe neurological disease (e.g. stroke), cancer or metabolic disease
Key exclusion criteria (2 listed)
- Significant cognitive impairment that may make it difficult to use the technological tools, together with unavailability of the caregiver to follow the project
- Unavailability of the caregiver to follow the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthcare deviceCE-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. | Device | FRAIL-CARE integrated home care |
| Remote monitoring by Specialist Operations CentresCase 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 | Other | FRAIL-CARE integrated home care |
| Blood drug concentration monitoring beyond routine TDMMeasurement 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. | Diagnostic test | FRAIL-CARE integrated home care |
Primary outcome
Change in health-related quality of life (EQ-5D-5L)
Time frame: Baseline (T0), 3 months (T1) and 6 months (T2)
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)
5 secondary outcomes
Usability of the technological solution (System Usability Scale)
Time frame: Baseline (T0), 3 months (T1) and 6 months (T2)
Adherence to therapy (MARS-5)
Time frame: 3 months (T1) and 6 months (T2)
Number of critical clinical events intercepted
Time frame: From enrolment to 6 months
Number of potentially dangerous events detected by drug level measurement
Time frame: From enrolment to 6 months
Blood drug levels
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 38115962The Lancet Regional Health-Europe. Securing the future of Europe's ageing population by 2050. Lancet Reg Health Eur. 2023 Dec 1;35:100807. doi: 10.1016/j.lanepe.2023.100807. eCollection 2023 Dec. No abstract available.
- Background: PubMed 15372591Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, Giladi N, Holloway RG, Moore CG, Wenning GK, Yahr MD, Seidl L; Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord. 2004 Sep;19(9):1020-8. doi: 10.1002/mds.20213.
- Background: PubMed 16757522Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing. 2006 Sep;35(5):526-9. doi: 10.1093/ageing/afl041. Epub 2006 Jun 6. No abstract available.
- Background: PubMed 33605412Theou O, Perez-Zepeda MU, van der Valk AM, Searle SD, Howlett SE, Rockwood K. A classification tree to assist with routine scoring of the Clinical Frailty Scale. Age Ageing. 2021 Jun 28;50(4):1406-1411. doi: 10.1093/ageing/afab006.
- Background: PubMed 31150177Swartz K, Collins LG. Caregiver Care. Am Fam Physician. 2019 Jun 1;99(11):699-706.
- Background: PubMed 34611721Laatikainen O, Sneck S, Turpeinen M. Medication-related adverse events in health care-what have we learned? A narrative overview of the current knowledge. Eur J Clin Pharmacol. 2022 Feb;78(2):159-170. doi: 10.1007/s00228-021-03213-x. Epub 2021 Oct 6.
- Background: PubMed 22642780Petrovic M, van der Cammen T, Onder G. Adverse drug reactions in older people: detection and prevention. Drugs Aging. 2012 Jun 1;29(6):453-62. doi: 10.2165/11631760-000000000-00000.
- Background: PubMed 18484788Franceschi M, Scarcelli C, Niro V, Seripa D, Pazienza AM, Pepe G, Colusso AM, Pacilli L, Pilotto A. Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit: a prospective study of 1756 patients. Drug Saf. 2008;31(6):545-56. doi: 10.2165/00002018-200831060-00009.
- Background: PubMed 23681400Lea M, Rognan SE, Koristovic R, Wyller TB, Molden E. Severity and management of drug-drug interactions in acute geriatric patients. Drugs Aging. 2013 Sep;30(9):721-7. doi: 10.1007/s40266-013-0091-y.
- Background: PubMed 17634320Bergman H, Ferrucci L, Guralnik J, Hogan DB, Hummel S, Karunananthan S, Wolfson C. Frailty: an emerging research and clinical paradigm--issues and controversies. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):731-7. doi: 10.1093/gerona/62.7.731.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthcare device, Remote monitoring by Specialist Operations Centres and Blood drug concentration monitoring beyond routine TDM in people with Frailty and Polypharmacy (People Under Treatment With 5 or More Drugs), run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (EQ-5D-5L) (time frame: Baseline (T0), 3 months (T1) and 6 months (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903584, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.