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Clinical Trials/NCT04830865
NCT04830865
Completed
Not Applicable

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

Hospital Universitario Getafe1 site in 1 country512 target enrollmentSeptember 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty Syndrome
Sponsor
Hospital Universitario Getafe
Enrollment
512
Locations
1
Primary Endpoint
Fragility scales's validation
Status
Completed
Last Updated
last year

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
September 15, 2019
End Date
October 5, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Universitario Getafe
Responsible Party
Principal Investigator
Principal Investigator

Susana Arias Rivera

Principal Investigator

Hospital Universitario Getafe

Eligibility Criteria

Inclusion Criteria

  • Critical care patients over 18 years who have given their consent personally.

Exclusion Criteria

  • Patients admitted with a diagnosis of present or imminent brain death,
  • readmissions previously included,
  • patients whose expected stay is less than 48 hours
  • patients with comunication problems

Outcomes

Primary Outcomes

Fragility scales's validation

Time Frame: 2 years

100% scale sensitivity

Secondary Outcomes

  • Obtaining adapted scales to patients in intensive care units in Spain(6 months)
  • Assessment of the predictive, convergent and divergent validity of the scales obtained (with respect to the original ones)(2 years)
  • Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones)(2 years)
  • Assessment of the sensitivity to change of the scales obtained (with respect to the original ones)(1 year)
  • Assessment of the minimum important difference of the scales obtained(2 years)

Study Sites (1)

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