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Recruiting NCT07442656

Frailty and Outcomes in Older Emergency Department Patients With Pneumonia

— Observational Community-Acquired Pneumonia Fraility Hospitalizations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical frailty scale, Clinical Frailty Scale (CFS).
Who it may be relevant to
Registry conditions: Community-Acquired Pneumonia, Fraility, Hospitalizations. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Other Clinical frailty scale
    Frailty assessment performed at emergency department presentation using the 9-point Clinical Frailty Scale.
  • Diagnostic test Clinical Frailty Scale (CFS)
    The Clinical Frailty Scale (CFS) will be assessed on a 1-9 scale. The CFS score obtained at presentation will also be compared with the patient's baseline CFS prior to the onset of the current illness symptoms.

Primary outcome measures

  • In hospital mortality [Time frame: During index hospitalization (7 and 14 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Özge Can — Izmir

Identifiers

NCT: NCT07442656 · 26-1.1T/96

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗