Gender-sensitive frailty prediction using clinical, biological, and psycho-social data
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)
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 type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 56 Years and up |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07109596 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- Sapienza University of Rome, University Hospital Policlinico Umberto I, Rome - UOC Internal medicine and Immunology — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Stefania Basili
- Email: stefania.basili@uniroma1.it
- Phone: +393393452523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.