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RECRUITING

NCT06611228

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

Sponsor: University of Milano Bicocca

View on ClinicalTrials.gov

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. 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.

Official title: Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2024-12-01

Completion Date

2026-01-01

Last Updated

2025-01-09

Healthy Volunteers

Conditions

Frailty Syndrome Aging

Interventions

OTHER

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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); * 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.

Locations (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lumbardy, Italy