Improving care for older patients to prevent disability after hospitalization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.