Frailty SyndromeOPTIMAge-ITNCT06611228
Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
A study testing Multidomain Interventions in people with Frailty Syndrome and Aging, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty Syndrome, Aging
- What is being tested?
- Multidomain Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age \>70 years;
- Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index [PC-FI] between 0.07 and 0.21, Clinical Frailty Scale [CFS] 4-6);
- Ability to walk with or without assistance
- Ability to communicate and cooperate with the research team;
- Ability to sign informed consent.
Who cannot join
- Expected hospital stay duration \<3 days;
- Estimated prognosis quoad vitam \<12 months;
- Persistent clinical instability, indicated by a NEWS2 score \>5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT \>4);
- History of schizophrenia, major depression, bipolar disorder, or psychosis;
- Severe sensory deficits (visual and auditory);
- Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);
Show all 14Show fewer
- Severe cardiac conduction disorder (e.g., third-degree atrioventricular block), uncontrolled arrhythmia, new Q wave in the past six months, or ST segment depression (\>3 mm) on the electrocardiogram;
- Terminal stage oncological or organic disease (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D chronic obstructive pulmonary disease, end-stage heart failure);
- Residence in a nursing home before hospital admission;
- Presence of dissected aortic aneurysm, severe aortic stenosis, acute endocarditis/pericarditis, acute thromboembolism, uncontrolled hypertension (\>180/100 mmHg) or postural hypotension, uncontrolled hypoglycemia, recent fracture within the last month, or any other medical condition that hinders the execution of physical activity according to clinical judgment;
- Any condition that prevents safe participation in the intervention and/or cooperation with the study;
- Concurrent participation in other clinical studies;
- Clinical conditions or situations significantly different from the condition under study, which in the investigator's opinion could interfere with the study or prevent optimal participation;
- Participants refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giuseppe Bellelli, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lumbardy, 20900
Chukwuma Okoye, MD, 003902223970, chukwuma.okoye@unimib.it
About this study
Official title: Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project
The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.
Participants will:
- Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care.
- Attend outpatient clinics for follow-up assessment at 3 and 6 months.
Read the detailed description
The "Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions (OPTIMAge-IT)" study will evaluate impact of a MDI multidisciplinary approach, enhanced by technological solutions, on the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty.
Additionally, the study will evaluate the feasibility and acceptability of delivering MDIs remotely via technology after hospital discharge. Using a parallel cluster-randomized design, approximately 300 patients will be recruited from eight Acute Geriatric Units (AGUs) located in eight acute hospitals evenly distributed across Northern, Central, and Southern Italy.
Eligible patients will be aged 70 years or older, with mild to moderate frailty, capable of ambulation with or without assistance and able to communicate and collaborate with the research team. Participants will use smart technologies, such as smartwatches, and tablets, for guided physical activity and remote monitoring. A multidisciplinary team -including a geriatrician, a nurse, a physiotherapist, a clinical nutrition expert, a neuropsychologist and a digital coach- will assist patients in the intervention group, supervising the MDI approach during hospitalization and at the 3-month follow-up. Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group, to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments.
After discharge, patients in the intervention group will continue MDI at home for 12 weeks, with follow-up visits at 3 and 6 months. The control group will receive a follow-up visit at 6 months.
- Conditions
- Frailty Syndrome, Aging
- Being tested
- Multidomain Interventions
- Keywords
- Hospital Acquired Disability, Frailty Syndrome, Comprehensive Geriatric Assessment, Prevention, Integrated Multidomain Interventions, Telemedicine, Telemonitoring, Outcomes, Hospital
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain InterventionsOther
Multidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The interventions include:
* Physical Exercise: Tailored sessions with the VIVIFRAIL exercise protocol, monitored with accelerometers, and supported by a physical activity kit.
* Nutrition: Mediterranean diet with education on nutrient balance and avoiding ultra-processed foods.
* Health \& Sleep: Promotion of healthy habits, fall prevention, sleep hygiene, and targeted sleep disorder treatments.
* Polypharmacotherapy: Review and adjustment of medications as needed.
* Cognition: Cognitive rehabilitation using technology and educational videos.
* Environment: Adjustments to create an "older-friendly" Acute Unit, including modified routines and extended visiting hours. Receives: Other: Multidomain Interventions |
| Control Group | No intervention | Centers randomized to the control group will follow usual care protocols. However, all participants in this group will receive standardized leaflets at discharge, providing physical, nutritional, and behavioral advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of the MDI on motor function at discharge from the AGU
Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12)
Measured: Baseline, Discharge (after an average hospital stay of 10 days)
Secondary outcomes (19)
Assess the effect of the MDI on readmissions at 6 months follow-up.
Effect of the MDI in reducing hospital readmissions at 6 months
Measured: 6 months
Evaluate the participant adherence to the protocol
Evaluate the participant adherence to the protocol assessing the number of drop-out and overall retention rates
Measured: 6 months
Evaluate the feasibility of home-based MDI with technological support
Feasibility of home-based MDI with technological support, evaluated using Patient Reported Experience Measures (PREMs), questionnaires measuring the patients' perceptions of their experience whilst receiving care
Measured: 3 months, and 6 months
Assess the effect of the MDI on readmissions at 3 months follow-up.
Effect of the MDI in reducing hospital readmissions at 3 months
Measured: 3 months
Evaluate the effect of the MDI on quality of life at follow-up.
Effect of the MDI on participants' quality of life at follow-up, evaluated using the EuroQol EQ-5D 5L, a descriptive system comprising five dimensions (mobility, self-care, usual activities, discomfort, and anxiety/depression), each dimension with five response levels (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems).
Measured: 3 months, 6 months
Evaluate the effect of the MDI on in-hospital mortality
Evaluate the effect of the MDI on in-hospital mortality
Measured: From Admission Through Discharge, an Average of 10 days
Evaluate the effect of the MDI on mortality at follow-up.
Evaluate the effect of the MDI on mortality at follow-up.
Measured: 3 months, 6 months
Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up.
Effect of the MDI in improving dietary intake and nutritional status at follow-up, assessed using the Mediterranean Diet Scale (MDScale, that includes nine components) and Mini Nutritional Assessment-Short Form (MNA-SF, 0-14)
Measured: Baseline, 3 months, 6 months
Evaluate the effect of the MDI on changes in frailty levels at follow-up.
Effect of the MDI in reducing frailty at follow-up, assessed using the Clinical Frailty Scale (CFS, 0-9) and Primary Care Frailty Index (PC-FI)
Measured: Baseline, 3 months, 6 months
Assess the effect of the MDI on fall events
Effect of the MDI in reducing the incidence of falls during hospitalization and at home, evaluated through the number of falls and the Tinetti Scale (0-28) occurred within the study period
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Evaluate the effect of the MDI on in-hospital complications
Effect of the MDI in reducing the incidence of in-hospital complications as sepsis, urinary infections, blood infections, and pressure ulcers.
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on sleep quality
Effect of the MDI on sleep quality during hospitalization and at home, assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of a combination of Likert-type and open-ended questions (which can later be converted into scaled scores using appropriate guidelines).
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on the incidence of delirium during hospitalization
Effect of the MDI in reducing incident delirium during hospitalization, diagnosed according to international guidelines (DSM V) and assessed using the Modified Richmond Agitation Screening Scale (m-RASS, scoring from -5 to +4), 4AT (scoring, from 0 to 12), and Delirium Rating Scale (DRS-revised, 13 items, each item is rated on a scale of 0- 2/3)
Measured: From Admission Through Discharge, an Average of 10 days
Assess the effect of the MDI on cognitive performance at follow-up.
Effect of the MDI on cognitive performance (assessed using the Cognitive Reserve Index questionnaire (CRIq), Addenbrooke Cognitive Examination - Revised (ACE-R), Trail Making Test (TMT) parts A and B)
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on functional performance at follow-up
Assessed using Basic Activities of Daily Living (ADL 0-6), Instrumental Activities of Daily Living (IADL 0-8), Barthel Index at follow-up (0-100)
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on motor performance at follow-up.
Assessed using SPPB (0-12), hand grip strength (Kg)
Measured: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the acceptability of technological solutions during hospitalization and at follow-up.
Acceptability of technological solutions through the administration of specific questionnaires
Measured: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
Evaluate the cost impact of the MDI on the healthcare system.
Costs of the MDI on the healthcare system, evaluated through the incremental cost-effectiveness ratio
Measured: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
Evaluate the effect of the MDI on the length of hospital stay.
Effect of the MDI in reducing the length of hospital stay
Measured: Discharge (after an average hospital stay of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Dec 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Bellelli, MD, Principal investigator, Università di Milano-BicoccaGiuseppe Bellelli, MD, Study chair, Università di Milano-Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611228
- Sponsor's protocol ID
- OPTIMAge-IT
- Acronym
- OPTIMAge-IT
- Status last verified
- May 2026
- First submitted
- 2 Sep 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.
PubMed 31275941Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.
PubMed 31609229Thillainadesan J, Scott IA, Le Couteur DG. Frailty, a multisystem ageing syndrome. Age Ageing. 2020 Aug 24;49(5):758-763. doi: 10.1093/ageing/afaa112.
PubMed 32542377Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16.
PubMed 31950775Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017.
PubMed 28579766de Souto Barreto P, Rolland Y, Maltais M, Vellas B; MAPT Study Group. Associations of Multidomain Lifestyle Intervention with Frailty: Secondary Analysis of a Randomized Controlled Trial. Am J Med. 2018 Nov;131(11):1382.e7-1382.e13. doi: 10.1016/j.amjmed.2018.06.002. Epub 2018 Jul 1.
PubMed 29969614Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
PubMed 25771249Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3.
PubMed 28898390Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
PubMed 37574781Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.
PubMed 30291317Perez LM, Enfedaque-Montes MB, Cesari M, Soto-Bagaria L, Gual N, Burbano MP, Tarazona-Santabalbina FJ, Casas RM, Diaz F, Martin E, Gomez A, Orfila F, Inzitari M. A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona. J Nutr Health Aging. 2019;23(8):710-716. doi: 10.1007/s12603-019-1244-4.
PubMed 31560028Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
PubMed 35150086Courel-Ibanez J, Buendia-Romero A, Pallares JG, Garcia-Conesa S, Martinez-Cava A, Izquierdo M. Impact of Tailored Multicomponent Exercise for Preventing Weakness and Falls on Nursing Home Residents' Functional Capacity. J Am Med Dir Assoc. 2022 Jan;23(1):98-104.e3. doi: 10.1016/j.jamda.2021.05.037. Epub 2021 Jun 29.
PubMed 34197791Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.
PubMed 30419096Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.
PubMed 8417639
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project
- ClinicalTrials.gov ID
- NCT06611228
- Acronym / sponsor ID
- OPTIMAge-IT / OPTIMAge-IT
- Conditions
- Frailty Syndrome, Aging
- Keywords
- Hospital Acquired Disability, Frailty Syndrome, Comprehensive Geriatric Assessment, Prevention, Integrated Multidomain Interventions, Telemedicine, Telemonitoring, Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Sep 2024 (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.
The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.
Participants will:
- Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care.
- Attend outpatient clinics for follow-up assessment at 3 and 6 months.
Detailed description
The "Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions (OPTIMAge-IT)" study will evaluate impact of a MDI multidisciplinary approach, enhanced by technological solutions, on the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty.
Additionally, the study will evaluate the feasibility and acceptability of delivering MDIs remotely via technology after hospital discharge. Using a parallel cluster-randomized design, approximately 300 patients will be recruited from eight Acute Geriatric Units (AGUs) located in eight acute hospitals evenly distributed across Northern, Central, and Southern Italy.
Eligible patients will be aged 70 years or older, with mild to moderate frailty, capable of ambulation with or without assistance and able to communicate and collaborate with the research team. Participants will use smart technologies, such as smartwatches, and tablets, for guided physical activity and remote monitoring. A multidisciplinary team -including a geriatrician, a nurse, a physiotherapist, a clinical nutrition expert, a neuropsychologist and a digital coach- will assist patients in the intervention group, supervising the MDI approach during hospitalization and at the 3-month follow-up. Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group, to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments.
After discharge, patients in the intervention group will continue MDI at home for 12 weeks, with follow-up visits at 3 and 6 months. The control group will receive a follow-up visit at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Multidomain InterventionsThe interventions include: * Physical Exercise: Tailored sessions with the VIVIFRAIL exercise protocol, monitored with accelerometers, and supported by a physical activity kit. * Nutrition: Mediterranean diet with education on nutrient balance and avoiding ultra-processed foods. * Health \& Sleep: Promotion of healthy habits, fall prevention, sleep hygiene, and targeted sleep disorder treatments. * Polypharmacotherapy: Review and adjustment of medications as needed. * Cognition: Cognitive rehabilitation using technology and educational videos. * Environment: Adjustments to create an "older-friendly" Acute Unit, including modified routines and extended visiting hours. |
| Control Group | No intervention | –Centers randomized to the control group will follow usual care protocols. However, all participants in this group will receive standardized leaflets at discharge, providing physical, nutritional, and behavioral advice. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age \>70 years;
- Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index [PC-FI] between 0.07 and 0.21, Clinical Frailty Scale [CFS] 4-6);
- Ability to walk with or without assistance
- Ability to communicate and cooperate with the research team;
- Ability to sign informed consent.
Key exclusion criteria (14 listed)
- Expected hospital stay duration \<3 days;
- Estimated prognosis quoad vitam \<12 months;
- Persistent clinical instability, indicated by a NEWS2 score \>5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT \>4);
- History of schizophrenia, major depression, bipolar disorder, or psychosis;
- Severe sensory deficits (visual and auditory);
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 |
|---|---|---|
| Multidomain InterventionsMultidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed | Other | Intervention Group |
Primary outcome
Assess the effect of the MDI on motor function at discharge from the AGU
Time frame: Baseline, Discharge (after an average hospital stay of 10 days)
Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12)
19 secondary outcomes
Assess the effect of the MDI on readmissions at 6 months follow-up.
Time frame: 6 months
Evaluate the participant adherence to the protocol
Time frame: 6 months
Evaluate the feasibility of home-based MDI with technological support
Time frame: 3 months, and 6 months
Assess the effect of the MDI on readmissions at 3 months follow-up.
Time frame: 3 months
Evaluate the effect of the MDI on quality of life at follow-up.
Time frame: 3 months, 6 months
Evaluate the effect of the MDI on in-hospital mortality
Time frame: From Admission Through Discharge, an Average of 10 days
Evaluate the effect of the MDI on mortality at follow-up.
Time frame: 3 months, 6 months
Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up.
Time frame: Baseline, 3 months, 6 months
Evaluate the effect of the MDI on changes in frailty levels at follow-up.
Time frame: Baseline, 3 months, 6 months
Assess the effect of the MDI on fall events
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Evaluate the effect of the MDI on in-hospital complications
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on sleep quality
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on the incidence of delirium during hospitalization
Time frame: From Admission Through Discharge, an Average of 10 days
Assess the effect of the MDI on cognitive performance at follow-up.
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on functional performance at follow-up
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the effect of the MDI on motor performance at follow-up.
Time frame: Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months
Assess the acceptability of technological solutions during hospitalization and at follow-up.
Time frame: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
Evaluate the cost impact of the MDI on the healthcare system.
Time frame: Discharge (after an average hospital stay of 10 days), 3 months, and 6 months
Evaluate the effect of the MDI on the length of hospital stay.
Time frame: Discharge (after an average hospital stay of 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 31275941Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019.
- Background: PubMed 31609229Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.
- Background: PubMed 32542377Thillainadesan J, Scott IA, Le Couteur DG. Frailty, a multisystem ageing syndrome. Age Ageing. 2020 Aug 24;49(5):758-763. doi: 10.1093/ageing/afaa112.
- Background: PubMed 31950775Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16.
- Background: PubMed 28579766Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017.
- Background: PubMed 29969614de Souto Barreto P, Rolland Y, Maltais M, Vellas B; MAPT Study Group. Associations of Multidomain Lifestyle Intervention with Frailty: Secondary Analysis of a Randomized Controlled Trial. Am J Med. 2018 Nov;131(11):1382.e7-1382.e13. doi: 10.1016/j.amjmed.2018.06.002. Epub 2018 Jul 1.
- Background: PubMed 25771249Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
- Background: PubMed 28898390Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3.
- Background: PubMed 37574781Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
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- Organization WH. World report on ageing and health \[Internet\]. Geneva PP - Geneva: World Health OrganizationLink provided by the sponsor.
- Organization WH. Integrated care for older people: guidelines on community-level interventions to manage declines in intrinsic capacity \[Internet\]. Geneva PP - Geneva: World Health Organization;Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Giuseppe Bellelli, MD contact
Giuseppe Bellelli, MD principal investigator
Università di Milano-Bicocca
Giuseppe Bellelli, MD study chair
Università di Milano-Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain Interventions in people with Frailty Syndrome and Aging, run by University of Milano Bicocca at 1 site 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Bellelli, MD (3392777327, giuseppe.bellelli@campus.unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of the MDI on motor function at discharge from the AGU (time frame: Baseline, Discharge (after an average hospital stay of 10 days)). 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 NCT06611228, which also lists 37 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 28 May 2026.