Clinical trial Recruiting at 1 site Observational Ages 56 and up

Gender-sensitive frailty prediction using clinical, biological, and psycho-social data

Official title: Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction (Age-It: Ageing Well in an Aging Society - A Novel Public-private Alliance to Generate Socioeconomic, Biomedical and Technological Solutions for an Inclusive Italian Ageing Society)

Run by University of Roma La Sapienza · NCT07109596 · Data updated 2026-11-12

This project will test whether combining clinical, biological, and gender-related social information can predict frailty in adults over 55 admitted to internal medicine or geriatric wards.

Quick facts

Study typeObservational
Ages56 Years and up
SexAll
Enrollment1000 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedJune 1, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2028
Registry record updatedAugust 7, 2025
Trial IDNCT07109596 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults older than 55 who are admitted to internal medicine or geriatric wards and do not have active cancer or need ICU-level care.

Probably not a fit

People undergoing surgery, those currently in intensive care, or patients with active malignancy would be excluded and are unlikely to benefit from this project.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will collect clinical, laboratory (including thrombo-inflammatory and nutritional markers), and psycho-social variables from patients aged over 55 admitted to internal medicine or geriatric units at Policlinico Umberto I in Rome. Investigators will create a gender-oriented frailty index and train an AI tool to apply that index during and after hospitalization. A secondary objective is to examine the relationship between nutritional status, thrombo-inflammatory markers, and the gender-oriented frailty score. The goal is to produce a practical, automated tool that incorporates sex and gender characteristics into frailty prediction for routine clinical use.

Why it matters

Potential benefit: If successful, the tool could help clinicians identify frail patients earlier and tailor care by accounting for sex and gender-related factors.

How similar studies have gone: Existing frailty indices and some AI prediction models have shown promise, but a gender-oriented frailty index combined with an AI tool remains relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* patients admitted in internal medicine or geriatric units
* age \> 55 years

Exclusion Criteria:

* Surgical patients, critical illness requiring admission to an intensive care unit, presence of an active malignancy.

Where it's running

  • Sapienza University of Rome, University Hospital Policlinico Umberto I, Rome - UOC Internal medicine and Immunology
    Roma, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.