Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 5:24 AM
Study NCT ID:
NCT07442656
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty and Outcomes in Older Emergency Department Patients With Pneumonia
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
Impact of Clinical Frailty Scale on Morbidity and Mortality in Older Adults Diagnosed With Pneumonia in the Emergency Department: A Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pneumonia is one of the leading causes of infection-related mortality in the older population. Traditional severity scores used in emergency departments, such as the Pneumonia Severity Index (PSI) and CURB-65, primarily focus on acute physiological derangements and may not adequately capture biological reserve and frailty in older adults. Frailty is a geriatric syndrome reflecting increased vulnerability to stressors and reduced recovery capacity.
This prospective observational cohort study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS) for in-hospital mortality, 30-day mortality, and morbidity in patients aged 65 years and older presenting to the emergency department with pneumonia. Additionally, the study will assess whether incorporating frailty assessment into existing pneumonia severity scores improves prognostic accuracy.
This prospective observational cohort study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS) for in-hospital mortality, 30-day mortality, and morbidity in patients aged 65 years and older presenting to the emergency department with pneumonia. Additionally, the study will assess whether incorporating frailty assessment into existing pneumonia severity scores improves prognostic accuracy.
Detailed Description:
Pneumonia represents a major cause of hospitalization, intensive care admission, and mortality in older adults worldwide. Aging is associated with multimorbidity and immunosenescence, increasing vulnerability to infection and poor outcomes. Current risk stratification tools used in emergency departments, including PSI and CURB-65, are designed to estimate short-term mortality based on acute clinical variables. However, these tools may not fully reflect functional reserve and biological age.
Frailty is characterized by decreased physiological reserve and increased susceptibility to adverse outcomes. The Clinical Frailty Scale (CFS), based on the deficit accumulation model, provides a rapid bedside assessment of global functional status using a 9-point scale. Emerging evidence suggests that frailty is an independent predictor of mortality and morbidity in older emergency department populations.
This single-center prospective observational cohort study will be conducted in a tertiary university hospital emergency department. Patients aged ≥65 years with a clinical and radiological diagnosis of pneumonia will be enrolled consecutively. Demographic data, comorbidities, vital signs, and PSI scores will be recorded at presentation. Frailty will be assessed using the Clinical Frailty Scale at the bedside.
The primary outcomes are in-hospital mortality and 30-day mortality. Secondary outcomes include intensive care unit admission and need for mechanical ventilation. Statistical analysis will evaluate whether CFS independently predicts outcomes and whether adding frailty assessment to existing pneumonia severity scores improves prognostic performance.
Frailty is characterized by decreased physiological reserve and increased susceptibility to adverse outcomes. The Clinical Frailty Scale (CFS), based on the deficit accumulation model, provides a rapid bedside assessment of global functional status using a 9-point scale. Emerging evidence suggests that frailty is an independent predictor of mortality and morbidity in older emergency department populations.
This single-center prospective observational cohort study will be conducted in a tertiary university hospital emergency department. Patients aged ≥65 years with a clinical and radiological diagnosis of pneumonia will be enrolled consecutively. Demographic data, comorbidities, vital signs, and PSI scores will be recorded at presentation. Frailty will be assessed using the Clinical Frailty Scale at the bedside.
The primary outcomes are in-hospital mortality and 30-day mortality. Secondary outcomes include intensive care unit admission and need for mechanical ventilation. Statistical analysis will evaluate whether CFS independently predicts outcomes and whether adding frailty assessment to existing pneumonia severity scores improves prognostic performance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: