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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04830865
Enrollment
512
Registered
2021-04-05
Start date
2019-09-15
Completion date
2024-10-05
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty Syndrome

Keywords

Frailty, critical care, gender, reliability, validity, study transcultural, quality of life

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).

Interventions

None listed

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital Universitario Getafe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fragility scales's validation2 years100% scale sensitivity

Secondary

MeasureTime frameDescription
Obtaining adapted scales to patients in intensive care units in Spain6 monthsThrough 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.
Assessment of the predictive, convergent and divergent validity of the scales obtained (with respect to the original ones)2 yearsUsing 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.
Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones)2 yearsThrough statistical tests, the interobserver and intraobserver concordance between nurses and physicians will be estimated.
Assessment of the sensitivity to change of the scales obtained (with respect to the original ones)1 yearThrough 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.
Assessment of the minimum important difference of the scales obtained2 yearsThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026