What predicts emergency department visits in frail older adults
Official title: Towards an Integrated Care System for the Assistance of Patients With Chronic Diseases, Multimorbidity, Frailty, and Polypharmacy
Run by University of Pisa · NCT07259499 · Data updated 2026-11-12
This project tests whether a blood marker (plasma pTau181) and signs of cerebrovascular damage can help predict which non-autonomous older adults will need to return to the emergency department within six months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa, Pisa) |
| Status | Recruiting |
| Started | November 19, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07259499 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Italian-speaking adults aged 65 or older with documented loss of autonomy in daily living and who have routine blood tests plus a head MRI or CT performed within the prior six months.
✕Probably not a fit
People without recent head imaging or routine bloodwork, those who remain autonomous in daily living, younger adults, or anyone who withdraws consent are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling non-autonomous adults over 64 to see if plasma phosphorylated tau181 and the degree of cerebrovascular burden predict emergency department use at six months. Eligible participants are Italian-speaking older adults with loss of daily living autonomies who have routine blood tests and head MRI or CT available from the prior six months; plasma pTau181 will be measured from blood. Cerebrovascular burden will be rated from existing neuroimaging and clinical and demographic data will be collected; the primary outcome is ED visits within six months with additional outcomes including mortality and readmission. Recruitment and follow-up are conducted at Azienda Ospedaliera Universitaria Pisana using medical record review and contact as needed.
Why it matters
Potential benefit: If successful, the approach could help identify high-risk older patients so clinicians can target prevention and reduce emergency visits and complications.
How similar studies have gone: Plasma pTau181 is an established Alzheimer’s biomarker and has been linked to delirium risk in hospitalized patients, but using pTau181 and cerebrovascular burden specifically to predict emergency department use is novel and largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * fluency in Italian language, * age higher than 64 years, * loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires, * having performed routinary blood exams in the 6 months prior to recruitment * having performed head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment. Exclusion Criteria: * withdrawal of the informed consent
Where it's running
-
Azienda Ospedaliera Universitaria Pisana
Pisa, Pisa, Italy Recruiting
Study contacts
- Principal investigator: Gabriele Siciliano, Professor, MD, PhD — University of Pisa
- Study coordinator: Francesco Turco, MD, PhD
- Email: francesco.turco@phd.unipi.it
- Phone: +39-050992905
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.