Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06729502

Pictorial Fit-Frail Scale in Adults Admitted to the ICU in a Tertiary Center- an Observational Prospective Study

Understanding the frailty levels of critically ill patients using the PFFS at time of admission to ICU.

Exploring any associations between frailty, other prognostic factors, and patient outcomes.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Frailty is a state of high vulnerability for adverse health outcomes, including disability, dependency, falls, need for long-term care, and mortality. Several definitions exist, but all measure one's vulnerabilities, strengths, and indirectly assess the physiological reserve. Frailty is not necessarily age dependent, but some of its domain are affected by age. In recent years, frailty has increasingly been recognized as an important factor in the prognosis assessment of an older critically ill patient, in terms of mortality (both in-hospital and long term), hospital length of stay (LOS) and discharge disposition. A previous study performed in Rabin Medical Center ICU demonstrated a strong association between frailty in 90-d mortality of critically ill patients. Frailty is also associated with a higher risk of persistent clinical illness (critical care dependency for survival).

There are several methods for frailty assessment; the comprehensive geriatric assessment is considered the gold standard. However, this method takes time, and requires full patient cooperation, both are usually not possible at the time of critical illness. Several other valeted methods are commonly used, including the Clinical Frailty Scale (CFS), Frailty Index, Frailty phenotype, simple FRAIL questionnaire modified frailty index, and many more.These tools have been validated in different settings, and were found related to several outcomes. There are several differences between the different tools. Some require clinical assessment (with or without patients cooperation), while others require only a review of the healthcare record (EHR). Nevertheless, there are differences between these tools in sensitivity, and specificity in terms of screening and diagnosis of frailty and the contributing factors to the state of frailty.

In 2019 the pictorial fit-frail scale (PFFS) has been introduced as a quick and easy-to-use tool for frailty assessment. It takes few minutes to fill by the patient or caregiver, it's not based on language or health literacy, and requires no clinical examination by the medical staff. The PFFS was validated in several clinical settings, including thoracic surgery clinic, geriatric clinic, memory clinic, and primary care clinics.

PFFS has been assessed in the critical care setting in our unit and was found associated with longer term mortality. The PFFS questionnaire has become a standard of care upon admission to our ICU. This study aims to describe the PFFS scores patients over 60 years old, its correlation with other prognostic scores, and its association with patients' outcomes (ICU length of stay, length of ventilation, ICU mortality, 90days mortality).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Older adults (age ≥ 60 years) who were admitted to the ICU for more than 24 hours at the participating centers

Exclusion criteria

  • Prior recent admission to an ICU (within 30 days)
  • Admissions for brain death evaluation.
  • Planned admissions to the ICU (i.e for percutaneous tracheostomy, for specific treatment under sedation).

Treatment and study plan

Questionnaire - Pictorial Fit-Frail Scale

Other

All patients over 60 years old, or their caregivers, will be asked to fill the PFFS questionnaire

Primary outcomes

  1. 90-d mortality

    Time frame: up to 90 days from ICU admission

    Mortality at 90 days from ICU admission

Secondary outcomes

  1. ICU mortality

    Time frame: During index admission

    Mortality during index admission at the ICU

  2. Hospital mortality

    Time frame: During index admission

    Mortality during hospital admission

  3. ICU length of stay

    Time frame: up to 90 days from ICU admission

    Duration of ICU admission

  4. Hospital length of stay

    Time frame: Up to 90 days from ICU admission

    Duration of hospital admission

Study contacts

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

Liran Statlender, MD

CONTACT

[email protected]

+97239376590

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Pictorial Fit-Frail Scale in Adults Admitted to the Intensive Care Unit in a Tertiary Center- an Observational Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Jul 23, 2025

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.

Published trials that share one or more normalized conditions with this study.