Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life

NCT06238557 | Completed

• 1 other identifier: 20220205-7
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to show the patient discomfort during their stay in intensive care is directly linked to the occurrence of a post ICU syndrome at 3 months. The main questions it aims to answer are :

• Evaluate the value of the IPREA score on quality of life impairment a 3 months ;
• Identify the 3 areas of discomfort most associated with progression to a post ICU syndrome at 3 months ;
• Define a threshold value for the IPREA score ;
• Correlate clinical assessment and psychological follow-up with the to the prediction of a post ICU syndrome ;
• Establish a correlation between IPREA score and time to first rise
• Establish a correlation between identified factors of post ICU syndrome and IPREA score

Conditions

Quality of Life; Post ICU Syndrome

Outcome Measures

Primary Outcomes (1)

• Assessing the impact of the overall discomfort of intensive care patients on the occurrence of a psychiatric RPD at 3 months

  Occurrence of discomfort in intensive care as defined by the IPREA score

  3 months

Secondary Outcomes (6)

• Assessing the value of the IPREA score in terms of quality of life at 3 months

  3 months

• Identifying the 3 areas of discomfort most associated with progression to post ICU syndrome at 3 months

  3 months

• Defining a threshold value for the IPREA score

  through study completion, an average of 1 year

• Correlation between clinical assessment and psychological follow-up with the post ICU syndrome

  through study completion, an average of 1 year

• Establish a correlation between IPREA score and time to first rise

  through study completion, an average of 1 year

Eligibility Criteria

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

Study Population

Patients admitted in ICU during minimum 3 days

You may qualify if:

• Patient admitted to the intensive care unit at Aix-en-Provence hospital (sepsis, acute respiratory distress, disturbed consciousness, emergency surgery, etc.)
• Minimum stay of 3 calendar days

You may not qualify if:

• Patient under 18 years
• Patients deprived of their liberty, under guardianship or trusteeship
• Non-French-speaking patient
• Presence of a pre-existing cognitive disorder as assessed by a clinician
• Participation in an interventional research protocol

Sponsors & Collaborators

• Romain Ronfle: lead

Study Sites (1)

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, 13100, France

Location

Study Officials

• Romain RONFLE, MD

  Centre Hospitalier Intercommunal Aix-Pertuis

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: September 8, 2022
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

FR (1)