Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
ID06611228

Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project

Led by University of Milano Bicocca · Updated on 2026-05-28

288

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a multidomain, multidisciplinary intervention (MDI), supported by technology, can improve the functional and cognitive health of older hospitalized patients who are at risk of disability or worsening frailty. This study focuses on patients aged 70 years and older with mild to moderate frailty and aims to assess the feasibility of delivering these interventions remotely after hospital discharge. Participants receiving the intervention will have a personalized MDI guided by a team including a geriatrician, nurse, physiotherapist, nutrition expert, neuropsychologist, and digital coach. The intervention includes tailored physical exercise, nutrition education based on a Mediterranean diet, health and sleep improvements, medication review, cognitive training using technology, and environmental adjustments to make the hospital more older-friendly. After hospital discharge, the intervention group continues with remote support at home for 12 weeks, while the control group receives usual care and standardized educational leaflets. During the study, participants will be assessed at hospital discharge and at 3 and 6 months after discharge. Researchers will monitor motor function, cognitive and functional performance, quality of life, adherence to the intervention, hospital readmissions, complications, sleep quality, mortality, dietary intake, frailty levels, and acceptability of technology. Biological samples will be collected for biomarker and gut microbiome analysis. The total follow-up includes outpatient visits at 3 and 6 months, with safety and feasibility evaluations ongoing throughout the study period.

CONDITIONS

Brief 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 greater than 70 years
  • Mild to moderate frailty (Primary Care Frailty Index between 0.07 and 0.21, Clinical Frailty Scale 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 shorter than 3 days
  • Estimated life expectancy less than 12 months
  • Persistent clinical instability (NEWS2 score greater than 5 within 48 hours of admission) or presence of delirium (4AT score greater than 4)
  • History of schizophrenia, major depression, bipolar disorder, or psychosis
  • Severe visual or hearing impairments
  • Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG)
  • Severe cardiac conduction disorders or uncontrolled arrhythmias
  • Terminal stage of cancer or severe organic diseases
  • Living in a nursing home before hospital admission
  • Certain serious cardiovascular or metabolic conditions preventing safe physical activity
  • Any condition preventing safe participation or cooperation
  • Concurrent participation in other clinical studies
  • Clinical conditions interfering with study participation as judged by the investigator
  • Refusal to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 10 days (average hospital stay)

Participants in the intervention group receive a personalized multidisciplinary intervention during hospitalization, including physical activity, nutrition, cognitive training, medication review, and environmental adjustments. Participants use smart technologies to support these activities.

Daily visits during hospital stay

Treatment

Duration - 12 weeks

After hospital discharge, participants in the intervention group continue the multidisciplinary intervention at home with technological support for 12 weeks, including physical activity, nutrition, and cognitive stimulation.

Remote monitoring with technological support and periodic coaching

Follow-up

Duration - 6 months

Participants in both groups have follow-up visits to assess functional and cognitive status, adherence, feasibility, and health outcomes.

Follow-up visits at 3 months and 6 months; control group has 1 visit at 6 months

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

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

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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