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RecruitingNCT06729502Updated Jul 23, 2025

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

An observational study in Frail, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Rabin Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,350
Ages
60 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Frail
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults aged 60 years old or more who admitted to the ICU for more than 24 hours, for any reason (except from those specified in the exclusion criteria)

Inclusion criteria

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

Exclusion criteria

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).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,350 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaire - Pictorial Fit-Frail Scale

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

05

What researchers measure

Primary outcomes

  1. 90-d mortality

    Mortality at 90 days from ICU admission

    Time frame: up to 90 days from ICU admission

Secondary outcomes

  1. ICU mortality

    Mortality during index admission at the ICU

    Time frame: During index admission

  2. Hospital mortality

    Mortality during hospital admission

    Time frame: During index admission

  3. ICU length of stay

    Duration of ICU admission

    Time frame: up to 90 days from ICU admission

  4. Hospital length of stay

    Duration of hospital admission

    Time frame: Up to 90 days from ICU admission

06

Study locations

1 of 1 sites recruiting
  • Rabin Medical Center
    Petah Tikva, Israel
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06729502
Lead sponsor
Rabin Medical Center
Responsible party
Liran Statlender (Senior Physician, principal investigator, Rabin Medical Center) — Principal investigator
First posted
Dec 11, 2024
Start date
Jan 26, 2025
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jul 23, 2025

Study contacts

Liran Statlender, MD
Contact
liranst1@clalit.org.il
+97239376590

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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