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

Frailty Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04830865
• Other study ID #: PI20/01231
• Secondary ID: CEIM19/42
• Status: Active, not recruiting
• Start date: September 15, 2019
• Est. completion date: August 29, 2024

Study information

• Verified date: October 2023
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 512
• Est. completion date: August 29, 2024
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Getafe	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fragility scales's validation	100% scale sensitivity	2 years
Secondary	Obtaining adapted scales to patients in intensive care units in Spain	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.	6 months
Secondary	Obtaining adapted scales to patients in intensive care units in Spain	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.	6 months
Secondary	Assessment of the predictive, convergent and divergent validity of the scales obtained (with respect to the original ones)	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.	2 years
Secondary	Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones)	Through statistical tests, the interobserver and intraobserver concordance between nurses and physicians will be estimated.	2 years
Secondary	Assessment of the sensitivity to change of the scales obtained (with respect to the original ones)	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.	1 year
Secondary	Assessment of the minimum important difference of the scales obtained	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.	2 years