Improving care for older patients to prevent disability after hospitalization
Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project
This study tests a new approach to help older patients in the hospital stay strong and healthy after they leave by providing extra support during and after their stay.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, Lumbardy) |
| Trial ID | NCT06611228 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a multidisciplinary intervention designed to enhance the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Participants aged 70 and older will receive a multidomain intervention during their hospital stay, followed by remote support for three months. The study will also assess the feasibility and acceptability of using technology for ongoing care after discharge. Approximately 300 patients will be recruited from eight hospitals across Italy, and their progress will be monitored through follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 70 years or older with mild to moderate frailty who can walk with or without assistance.
Not a fit: Patients with severe clinical instability, significant psychiatric disorders, or those expected to have a short hospital stay may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and independence of older patients after hospitalization.
How similar studies have performed: Other studies have shown promise with similar multidisciplinary approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Monza, Lumbardy
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Lumbardy, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Bellelli, MD — Università di Milano-Bicocca
- Study coordinator: Giuseppe Bellelli, MD
- Email: giuseppe.bellelli@campus.unimib.it
- Phone: 3392777327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.