Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830865
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2021-03-25
Brief Title:
Adaptation and Validation of Frailty Scales in Intensive Care Units in Spain
Sponsor:
Hospital Universitario Getafe
Organization:
Hospital Universitario Getafe
Study Overview
Official Title:
Adaptation and Validation of Frailty Scales in Critically Ill Patients Admitted to Intensive Care Units in Spain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 phasesPhase 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
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 phasesPhase 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEIM1942 | OTHER | Hospital Universitario de Getafe | None |