Clinical trial NCT05111522: Health-related Quality of Life and Functional Impairments After Intensive Care Unit Discharge
Official title: Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Health-related Quality of Life
Keywords: Health-related quality of life
Morbidity
Long terms outcomes
Post intensive care syndrome
Intensive Care Unit
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Legriel Stéphane
First posted: 2021-11-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who meet the eligibility criteria will be offered participation in the study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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 :
timeFrame: 24month
Secondary outcomes:
measure: 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 :
timeFrame: 24 month
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Versailles hospital
Study officials:
affiliation: Versailles Hospital
name: Gwenaëlle JACQ, RN,MSc
role: PRINCIPAL_INVESTIGATOR
References: