{"type":"trials","record":{"id":35404,"source_id":"clinicaltrials-gov","external_id":"NCT04830865","title":"Adaptation and Validation of Frailty Scales in Intensive Care Units in Spain","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).","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Hospital Universitario Getafe","enrollment":512,"countries":["Spain"],"start_date":"2019-09-15","completion_date":"2024-10-05","last_update_date":"2025-03-13","source_url":"https://clinicaltrials.gov/study/NCT04830865","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years","comparator":null,"organization":"Hospital Universitario Getafe","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Fragility scales's validation — 2 years","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 on…","Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones…","Assessment of the sensitivity to change of the scales obtained (with respect to the original ones) — 1 year","Assessment of the minimum important difference of the scales obtained — 2 years"],"design_description":null,"source_has_results":false},"controlled_terms":["Frailty Syndrome"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct04830865","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-09-15 to 2024-10-05","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.520Z","intervention":[],"participants":512,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Fragility scales's validation — 2 years","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 on…","Assessment of the interobserver and intraobserver reliability of the scales obtained (with respect to the original ones…","Assessment of the sensitivity to change of the scales obtained (with respect to the original ones) — 1 year","Assessment of the minimum important difference of the scales obtained — 2 years"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35404","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}