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NCT Number: NCT07442656

Frailty and Outcomes in Older Emergency Department Patients With Pneumonia

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Frailty Scale

Other

Frailty assessment performed at emergency department presentation using the 9-point Clinical Frailty Scale.

Clinical Frailty Scale (CFS)

Diagnostic Test

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Özlem İnci, MD

CONTACT

[email protected]

902323902321

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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