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Clinical Trials/NCT05111522
NCT05111522
Not yet recruiting
Not Applicable

Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study

Versailles Hospital1 site in 1 country500 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health-related Quality of Life
Sponsor
Versailles Hospital
Enrollment
500
Locations
1
Primary Endpoint
Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales :
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.

Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.

Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.

Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.

Detailed Description

The investigators therefore propose the constitution of a longitudinal cohort evaluating the HRQoL, and allowing the analysis of its determinants in the global population of intensive care patients.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jacq Gwenaelle

principal investigator

Versailles Hospital

Eligibility Criteria

Inclusion Criteria

  • all adult patients(age\>18) hospitalized in ICU

Exclusion Criteria

  • legal guardianship
  • opposition to participate
  • unread and unwritten French language

Outcomes

Primary Outcomes

Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales :

Time Frame: 24month

i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score\[0-100\], a high score indicate better health status. ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score\[1-8\] a hight score indicate no handicap. Barthel index (Dependency)-Ranging score\[0-100\], a high score indicate no dependency. The Fatigue Severity Scale(fatigue)-Ranging score\[9-63\],a high score indicate a greater fatigue severity. The Hospital anxiety and depression (Anxiety,Depression)-Ranging score\[0-21\] a score \> 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score\[0-88\],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score\[0-30\] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score\[0-22\],a score of 18 and higher generally is considered normal.

Secondary Outcomes

  • Presence or not of elements associated with i) HRQOL impairements defined by ii)physical and/or psychological and /or cognitive impairments in the global population and in differents sub-groups of interest, according to the to following scales :(24 month)

Study Sites (1)

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