Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
NCT Number: NCT04830865
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).
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Notify Me18 year and older
All sexes
Observational
Getafe, Madrid, 28905, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
100% scale sensitivity
Time frame: 6 months
Through a process of cross-cultural, FRAIL scale will be implemented in spanish. Minimun value is 0 and maximum value is 5. Value of 0 is not frail, values of 1 or 2 is prefrail and values of 3 to 5 is frail.
Time frame: 6 months
Through a process of cross-cultural adaptation, Clinical Frailty Scale (CFS) will be implemented in spanish. Minimun value is 0 and maximum value is 9. Values of 0 to 3 is not frail, values of 4 is vulnerable, and 5 or 9 is frail.
Time frame: 2 years
Using statistical tests, the validity of the scales will be estimated in relation to the variables which it should or should not have concordance and its predictive capacity.
Time frame: 2 years
Through statistical tests, the interobserver and intraobserver concordance between nurses and physicians will be estimated.
Time frame: 1 year
Through statistical tests, the floor and ceiling of the scales and the change in the score of the scales obtained between baseline and 3, 6, 9 and 12 months after hospital discharge will be assessed.
Time frame: 2 years
The relevance of the change in the score on the scales will be assessed, from the point of view of the patient and the professionals, related to quality of life.
Hospital Universitario Getafe
Other
Adaptation and Validation of Frailty Scales in Critically Ill Patients Admitted to Intensive Care Units in Spain
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