Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT06611228

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

Led by University of Milano Bicocca · Updated on 2025-01-09

288

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 70 years
  • Mild to moderate frailty as defined by specific frailty indexes (PC-FI between 0.07 and 0.21, CFS 4-6)
  • Ability to walk with or without assistance
  • Ability to communicate and cooperate with the research team
  • Ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Expected hospital stay less than 3 days
  • Life expectancy less than 12 months
  • Persistent clinical instability (NEWS2 score over 5 within 48 hours of admission) or presence of delirium (4AT over 4)
  • History of schizophrenia, major depression, bipolar disorder, or psychosis
  • Severe visual or hearing impairments
  • Presence of nasogastric tube or PEG
  • Severe heart conduction problems or recent significant ECG changes
  • Terminal oncological or organic diseases (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D COPD, end-stage heart failure)
  • Living in a nursing home before hospital admission
  • Certain severe cardiovascular or medical conditions preventing physical activity
  • Any condition preventing safe participation or cooperation
  • Participation in other clinical studies
  • Medical conditions that could interfere with study participation
  • Refusal to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lumbardy, Italy, 20900

Actively Recruiting

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Research Team

G

Giuseppe Bellelli, MD

CONTACT

G

Giuseppe Bellelli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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