Status:
RECRUITING
Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions
Lead Sponsor:
University of Milano Bicocca
Conditions:
Frailty Syndrome
Aging
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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 h...
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 techn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06611228
Start Date
December 1 2024
End Date
January 1 2026
Last Update
January 9 2025
Active Locations (1)
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1
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lumbardy, Italy, 20900