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

NCT ID: NCT06729502

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-26
• Study Completion Date: 2027-03-31

Brief 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.

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).

Conditions

Frail

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaire - Pictorial Fit-Frail Scale

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

Intervention Type: OTHER

Eligibility 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

• 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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Liran Statlender

Senior Physician, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Liran Statlender, MD

Role: CONTACT

liranst1@clalit.org.il

+97239376590

Facility Contacts

Liran Statlender

Role: primary

liranst1@clalit.org.il

+97239376590

Other Identifiers

0377-24-RMC

Identifier Type: -

Identifier Source: org_study_id