Clinical Trials Directory

Trials / Completed

CompletedNCT04830865

Adaptation and Validation of Frailty Scales in Intensive Care Units in Spain

Adaptation and Validation of Frailty Scales in Critically Ill Patients Admitted to Intensive Care Units in Spain

Status
Completed
Phase
Study type
Observational
Enrollment
512 (actual)
Sponsor
Hospital Universitario Getafe · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Increased life expectancy leads to population aging, increased morbidities and aging of hospitalized patients. The acquisition of frailty leads to worse outcomes derived from hospitalization, but although frailty has been related to aging, young patients admitted to Intensive Care Units (ICU) with frailty have also been found to have worse outcomes than non-frail patients. This unfavorable evolution could be related to the acquisition of the post-uci syndrome (physical, mental and cognitive sequelae at discharge from the ICU), since high frailty scores favor this syndrome. The use of frailty scales on admission to the ICU could provide early detection of patients most likely to develop post-ICU syndrome, regardless of age, and redirect our care to those who need it most. Some scales that measure frailty in elderly patients have been used in the ICU, but although they have been validated in their original language, they need to be adapted and validated in Spanish. Objectives. Adaptation and validation of the Clinical Frailty Scale (CFS) and the FRAIL Scale in ICU patients of different ages, in women and in men. Methodology. Study developed in two phases.Phase 1, adaptation to Spanish of the scales (translation, pilot, back-translation, correlation); Phase 2, analysis of their metric properties (Validity, Reliability, Sensitivity, Minimum important difference) by means of a multicenter observational study (7 ICUs in Spain), prospective, descriptive, of a cohort of critical patients with one-year follow-up (at 3, 6, 9 and 12 months after hospital discharge).

Conditions

Timeline

Start date
2019-09-15
Primary completion
2024-10-05
Completion
2024-10-05
First posted
2021-04-05
Last updated
2025-03-13

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04830865. Inclusion in this directory is not an endorsement.