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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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