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临床试验/NCT04830865
NCT04830865已完成不适用

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

Hospital Universitario Getafe1 个研究点 分布在 1 个国家目标入组 512 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
512
试验地点
1
主要终点
Fragility scales's validation

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Fragility scales's validation

时间窗: 2 years

100% scale sensitivity

次要结局

  • 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)
  • Assessment of the minimum important difference of the scales obtained(2 years)

研究者

发起方
Hospital Universitario Getafe
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susana Arias Rivera

Principal Investigator

Hospital Universitario Getafe

研究点 (1)

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