What is this study trying to find out about frailty syndrome in older adults?

This study is evaluating whether a multidomain intervention enhanced by technology can improve the functional and cognitive status of older patients at risk of disability or worsening frailty. Led by the University of Milano Bicocca, it aims to test both the effectiveness and feasibility of delivering these interventions during and after hospitalization.

Who may be eligible for this frailty syndrome clinical trial?

Adults aged 70 or older with mild to moderate frailty who can walk with or without assistance and can communicate with the research team may be eligible. People with severe mental illness, short expected hospital stays, or unstable clinical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this frailty syndrome clinical trial?

Study-related care, including all interventions and trial visits, is provided at no cost. However, personal travel expenses for visits or technology use may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 70Years +

All Genders

ID06611228

Improving Functional and Cognitive Health of Hospitalized Older Adults With Frailty Using Multidomain Interventions and Technology

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

288

Participants Needed

Research Sites

26 weeks

Total Duration

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

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

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

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