NCT06611228

Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The "Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions (OPTIMAge-IT)" study will evaluate impact of a MDI multidisciplinary approach, enhanced by technological solutions, on 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 MDIs remotely via technology after hospital discharge. Using a parallel cluster-randomized design, approximately 300 patients will be recruited from eight Acute Geriatric Units (AGUs) located in eight acute hospitals evenly distributed across Northern, Central, and Southern Italy. Eligible patients will be aged 70 years or older, with mild to moderate frailty, capable of ambulation with or without assistance and able to communicate and collaborate with the research team. Participants will use smart technologies, such as smartwatches, and tablets, for guided physical activity and remote monitoring. A multidisciplinary team -including a geriatrician, a nurse, a physiotherapist, a clinical nutrition expert, a neuropsychologist and a digital coach- will assist patients in the intervention group, supervising the MDI approach during hospitalization and at the 3-month follow-up. Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group, to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments. After discharge, patients in the intervention group will continue MDI at home for 12 weeks, with follow-up visits at 3 and 6 months. The control group will receive a follow-up visit at 6 months.

Conditions

• Frailty Syndrome
• Aging

Interventions

Type	Name	Description
OTHER	Multidomain Interventions	Multidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-09-24
• Last updated: 2025-01-09

Locations

1 site across 1 country: Italy