- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442656
Frailty and Outcomes in Older Emergency Department Patients With Pneumonia
Impact of Clinical Frailty Scale on Morbidity and Mortality in Older Adults Diagnosed With Pneumonia in the Emergency Department: A Prospective Observational Cohort Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Özlem İnci, MD
- Phone Number: 902323902321
- Email: ozge.can@ege.edu.tr
Study Locations
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Bornova
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Izmir, Bornova, Turkey (Türkiye), 35100
- Recruiting
- Özge Can
-
Contact:
- Özge Can
- Phone Number: +902323902321
- Email: ozge.can@ege.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥65 years
- Clinical and radiological diagnosis of pneumonia in the emergency department
- Ability to obtain informed consent from the patient or legal representative
- Availability of a caregiver or relative able to describe baseline functional status
Exclusion Criteria:
- Presentation with cardiopulmonary arrest or ongoing cardiopulmonary resuscitation at admission
- Confirmed COVID-19 pneumonia
- Inability to obtain reliable baseline functional history due to absence of an informant
- Refusal to provide informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In hospital mortality
Time Frame: During index hospitalization (7 and 14 days)
|
All-cause mortality occurring during the same hospital admission after emergency department presentation.
|
During index hospitalization (7 and 14 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-1.1T/96
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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