CritiQoL2: Health-related Quality of Life and Functional Impairments After Intensive Care Unit Discharge

Sponsor
Versailles Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05111522
Collaborator
Legriel Stéphane (Other)
500
1
36
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2026
    Anticipated Study Completion Date :
    Jan 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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 : [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 Outcome Measures

    1. 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]

      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..

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all adult patients(age>18) hospitalized in ICU
    Exclusion Criteria:
    • legal guardianship

    • opposition to participate

    • unread and unwritten French language

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Versailles hospital Le Chesnay France

    Sponsors and Collaborators

    • Versailles Hospital
    • Legriel Stéphane

    Investigators

    • Principal Investigator: Gwenaëlle JACQ, RN,MSc, Versailles Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacq Gwenaelle, principal investigator, Versailles Hospital
    ClinicalTrials.gov Identifier:
    NCT05111522
    Other Study ID Numbers:
    • P21/07_CritiQol2
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jacq Gwenaelle, principal investigator, Versailles Hospital

    Study Results

    No Results Posted as of Jul 27, 2022