Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
NCT ID: NCT06611228
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
288 participants
INTERVENTIONAL
2024-12-01
2026-01-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group
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.
Multidomain Interventions
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
Control Group
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.
No interventions assigned to this group
Interventions
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Multidomain Interventions
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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);
* 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.
70 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Bellelli, MD
Role: PRINCIPAL_INVESTIGATOR
Università di Milano-Bicocca
Giuseppe Bellelli, MD
Role: STUDY_CHAIR
Università di Milano-Bicocca
Locations
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Fondazione IRCCS San Gerardo dei Tintori
Monza, Lumbardy, Italy
Countries
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Central Contacts
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Giuseppe Bellelli, MD
Role: CONTACT
Facility Contacts
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References
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Related Links
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Organization WH. World report on ageing and health \[Internet\]. Geneva PP - Geneva: World Health Organization
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;
Other Identifiers
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OPTIMAge-IT
Identifier Type: -
Identifier Source: org_study_id
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