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

NCT04830865 | Completed

• 2 other identifiers: PI20/01231CEIM19/42
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

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).

Conditions

Frailty Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fragility scales's validation

  100% scale sensitivity

  2 years

Secondary Outcomes (6)

• Obtaining adapted scales to patients in intensive care units in Spain

  6 months

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who remain hospitalized for more than 48 hours in any of the 8 Spanish intensive care units participating in the study, they will be candidates for inclusion in the study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Frailty; Coitus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: September 15, 2019
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

ES (1)