Predictors of Emergency Department Use in Frail Patients

NCT07259499 | Recruiting

• 1 other identifier: 25312_SICILIANO
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.

Conditions

Alzheimer s Disease; Vascular Dementia; Frailty; Elderly; Emergency Department Visits; Autonomy

Keywords

phosphorylated tau 181; dementia; Emergency Department; Frailty; Autonomies; Elderly; cerebrovascular

Outcome Measures

Primary Outcomes (1)

• Emergency Department Use

  The patient visits an emergency department (ED). The proportion of participants visiting the ED will be assessed at the end of the observational period. Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.

  Within 6 months from recruitment

Secondary Outcomes (1)

• Time to emergency department use

  Within 6 months from recruitment.

Study Arms (1)

Elderly, non-autonomous Patients

Adult participants fulfilling the following 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 blood exams and a head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment.

Diagnostic Test: Plasma phosphorylated Tau 181

Interventions

Plasma phosphorylated Tau 181 DIAGNOSTIC_TEST

Plasma will be collected in dipotassium EDTA tubes at recruitment and centrifugated at 1800-2000xg for 10 minutes within a short data frame. Plasma will be subsequently aliquoted and stored at -80°C. Immediately prior to analysis, samples will be thawed at room temperature, vortexed, and centrifuged. Plasma p-tau181 concentrations will be then quantified using a fully automated chemiluminescent enzyme immunoassay on the LUMIPULSE G600II system, in accordance with the manufacturer's instructions.

Elderly, non-autonomous Patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults fulfilling the inclusion criteria consecutively recruited during their outpatient visits at the Neurology and Geriatrics Units of the Pisa University Hospital (Italy).

You may qualify if:

• 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.

You may not qualify if:

• withdrawal of the informed consent

Sponsors & Collaborators

• University of Pisa: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Dementia, Vascular; Frailty; Dementia; Emergencies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Gabriele Siciliano, Professor, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Turco, MD, PhD

CONTACT

+39-050992905; francesco.turco@phd.unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: November 19, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Access Criteria: The anonymized data underlying this article will be shared on reasonable request to the corresponding author of the published study.

Locations

IT (1)