Overview

This trial is active, not recruiting.

Condition intensive care units
Treatment phone call to evaluate the social changes, emotional, professional a cohort of patients following icu stay
Sponsor Groupe Hospitalier Paris Saint Joseph
Start date October 2014
End date June 2016
Trial size 100 participants
Trial identifier NCT02819154, SEPPICC

Summary

Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened with a high mortality rate. Invasive methods of resuscitation and the diseases treated can lead to serious sequelae. Follow-up studies of patients at hospital discharge report most often the quality of life using validated quantitative scales. A recent consensus of the American Society of resuscitation an update on the physical, cognitive and psychological sequelae of ICU hospitalization for the family and the patient, grouped under the term "post-intensive care syndrome." Social changes, emotional and professional are little studied and are not part of the information provided by the quality of life questionnaires. The investigators hypothesize that intensive care stay entails a profound effect on the lives of patients. This study will add additional data on a little known aspect of post resuscitation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Assessment of change of Life quality with SP 36 questionnary
time frame: Day 0 at the end of hospitalization, 6 months after hospitalization

Secondary Outcomes

Measure
Stress Assessment Questionnaire posttraumatic
time frame: Day 0 at the end of hospitalization, 6 months after hospitalization
Assessment of independence in activities of daily life
time frame: Day 0 at the end of hospitalization, 6 months after hospitalization

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patient admitted in ICU and who had at least one organ dysfunction (need at least 24 hours of mechanical ventilation) in two intensive care units Exclusion Criteria: - Patient Do not speak French - Patient aphasic deaf - Patient with xxistencing cognitive disorders - Homeless

Additional Information

Official title Study of the Social and Psychological Consequences of ICU Hospitalization
Principal investigator GARROUSTE Maite, MD
Description Primary objective : To evaluate the social changes, emotional, professional a cohort of patients following ICU stay Secondary objective: Evaluate post traumatic stress disorder and quality of life of a cohort of patients following ICU stay Methods : Study design Study of bi-center cohort (ICUs of Saint Joseph and Bichat hospitals). prospective follow the consequences of the intensive use of patient already included in the Outcomerea database using quality of life questionnaires, independence and post-traumatic stress and a questionnaire constructed for the study. Patient selection in the database The database contains more than 10,000 visits. Investigators will select the patients in the two hospitals in the study. Then a second selection will be based on the inclusion criteria. The review of hospital records will not include patients with the first five criteria for non-inclusion. These patients appear in the flow chart
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Groupe Hospitalier Paris Saint Joseph.