Health-related Quality of Life and Functional Impairments After Intensive Care Unit Discharge

Health-related Quality of Life Clinical Trial

— CritiQoL2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05111522
• Other study ID #: P21/07_CritiQol2
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: July 2022
• Source: Versailles Hospital
• Contact: Gwenaëlle JACQ, RN, MSc
• Phone: 0139638356
• Email: gjacq[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• legal guardianship

• opposition to participate

• unread and unwritten French language

Related Conditions & MeSH terms

• Health-related Quality of Life

Locations

Country	Name	City	State
France	Versailles hospital	Le Chesnay

Sponsors (2)

Lead Sponsor	Collaborator
Versailles Hospital	Legriel Stéphane

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 :	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.	24month
Secondary	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 :	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..	24 month