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

NCT05111522 | Unknown

• 1 other identifier: P21/07_CritiQol2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Health-related Quality of Life

Keywords

Health-related quality of life; Morbidity; Long terms outcomes; Post intensive care syndrome; Intensive Care Unit

Outcome Measures

Primary Outcomes (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 :

  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 Outcomes (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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients who meet the eligibility criteria will be offered participation in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Versailles Hospital: lead
• Legriel Stéphane: collaborator

Study Sites (1)

Versailles hospital

Le Chesnay, France

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Gwenaëlle JACQ, RN,MSc

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwenaëlle JACQ, RN, MSc

CONTACT

0139638356; gjacq@ch-versailles.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 8, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)