- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07339891
Experience of Staying in Intensive Care and Impact on Quality of Life (Expe-Rea)
It now seems well established that post-traumatic stress disorder following a stay in intensive care is one of the factors that affects patients' quality of life after they leave hospital.
Several qualitative and quantitative studies suggest that there are several factors associated with the onset of this post-traumatic stress disorder, including the absence of memory of the stay in intensive care. With this in mind, some intensive care units (in France and abroad) are implementing measures to improve the patient experience during their stay, particularly to compensate for this lack of memory: several studies show a link between the introduction of intensive care unit logbooks and a decrease in the incidence of post-traumatic stress disorder after returning home.
The aim of this research project is to measure the experience of the stay in intensive care and its possible impact on quality of life. It is therefore part of a process of implementing measures within general and cardiovascular surgical intensive care units, aimed at better assessing and improving the quality of life of patients after a stay in intensive care.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Coralie PAUZET, MD
- Phone Number: 33 3 69 55 05 57
- Email: coralie.pauzet@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de Réanimation Chirurgicale - CHU de Strasbourg - France
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Sub-Investigator:
- Julien GODET, Statistician
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Contact:
- Coralie PAUZET, MD
- Phone Number: 33 3 69 55 05 57
- Email: coralie.pauzet@chru-strasbourg.fr
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Principal Investigator:
- Coralie Pauzet, MD
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Sub-Investigator:
- Margot TRIBOULET, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient (≥ 18 years)
- Stay in intensive care > 48 hours
Exclusion Criteria:
- Admission to intensive care following scheduled surgery.
- Readmission to intensive care (previous admission within the 30 days prior).
- Patient under legal guardianship
- Inability to complete a questionnaire
- Poor reading and/or speaking comprehension of French
- Patient under guardianship or conservatorship.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICE questionnaire score
Time Frame: Between 1 and 3 days after discharge from the intensive care unit.
|
ICE (Impact Confidence Experience) questionnaire score: The scores for each letter (I, C, E) are added together or averaged. The higher the score, the better. This indicates a positive experience, trust, and a significant impact. Simple example:
Average ICE score = (8 + 9 + 7) ÷ 3 = 8/10 |
Between 1 and 3 days after discharge from the intensive care unit.
|
|
Quality of life questionnaire score (SF36)
Time Frame: Day 30 after discharge from hospital
|
The SF-36 is a health questionnaire consisting of 36 questions. Each dimension receives a score from 0 to 100:
|
Day 30 after discharge from hospital
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9771
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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