Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit (COPRéa)

November 4, 2024 updated by: Centre Hospitalier Universitaire Dijon

A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.

Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.

All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.

One month after discharge from the ICU, the patients will be randomly assigned to

  • either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
  • or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Person who has given oral consent
  • Patient 18 years of age or older
  • Patient with at least one organ failure
  • Patient with a stay of 6 days or more

Exclusion Criteria:

  • Person who is not affiliated or not a beneficiary of a social security system
  • Patient at the end of his/her life
  • Patient who does not speak French
  • Minor (< 18 years old)
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • Pregnant, parturient or breastfeeding women
  • Patient incarcerated
  • Patient with a psychiatric history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient managed under standard practice conditions
Other: Psychological and quality of life questionnaires
At 4/5 months and at 9 months
Experimental: Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU
Other: Psychological and quality of life questionnaires
At 4/5 months and at 9 months
Other: Interdisciplinary consultation at 4/5 months
About ten days after the questionnaires were administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MOS SF-36 Quality of Life Scale Score
Time Frame: Between 4/5 and 9 months after discharge from intensive care
Between 4/5 and 9 months after discharge from intensive care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LAURENT UB 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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