Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
ID06611228

Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions The Age-IT Project for Older Patients at Risk of Frailty

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

Researchers are evaluating a multidomain, multidisciplinary intervention (MDI) enhanced by technology to improve the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. This trial involves patients aged 70 years or older with mild to moderate frailty who can walk with or without assistance and are able to communicate and cooperate. The study aims to assess both the intervention's effects during hospitalization and the feasibility of continuing support remotely after discharge. Participants in the intervention group will receive personalized MDI from a multidisciplinary team including a geriatrician, nurse, physiotherapist, clinical nutrition expert, neuropsychologist, and digital coach. The approach includes physical activity programs, nutritional interventions, cognitive training, medication review, coaching on technology use, group activities, and home environment modifications. The intervention begins during a hospital stay averaging around 10 days and continues remotely at home for 12 weeks, with follow-up visits at 3 and 6 months. The control group receives usual care and a follow-up visit at 6 months. Participants will be monitored through the use of smartwatches and tablets for guided activity and remote assessment. Researchers will collect blood and fecal samples for biomarker and microbiome analysis in the intervention group. Outcomes include feasibility of home-based MDI with technology over 3 and 6 months, adherence to the protocol over about 1 year, and effects on motor function at hospital discharge. Follow-up assessments occur at hospital discharge, 3 months, and 6 months to track functional and cognitive changes and safety throughout the study.

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lumbardy, Italy, 20900

Actively Recruiting

Loading map...

Research Team

G

Giuseppe Bellelli, MD

G

Giuseppe Bellelli, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review.

Lenore Dedeyne, Mieke Deschodt, Sabine Verschueren...

https://pubmed.ncbi.nlm.nih.gov/28579766

Associations of Multidomain Lifestyle Intervention with Frailty: Secondary Analysis of a Randomized Controlled Trial.

Philipe de Souto Barreto, Yves Rolland, Mathieu Maltais...

https://pubmed.ncbi.nlm.nih.gov/29969614

A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.

Tiia Ngandu, Jenni Lehtisalo, Alina Solomon...

https://pubmed.ncbi.nlm.nih.gov/25771249

Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program.

Maria Cristina Ferrara, Laura Mónica Pérez, Aida Ribera Sole...

https://pubmed.ncbi.nlm.nih.gov/37574781