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Clinical Trials/NCT02819154
NCT02819154
Completed
Not Applicable

Study of the Social and Psychological Consequences of ICU Hospitalization

Fondation Hôpital Saint-Joseph1 site in 1 country100 target enrollmentOctober 24, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Units
Sponsor
Fondation Hôpital Saint-Joseph
Enrollment
100
Locations
1
Primary Endpoint
Assessment of change of Life quality with SP 36 questionnary
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Detailed 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

Registry
clinicaltrials.gov
Start Date
October 24, 2014
End Date
June 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of change of Life quality with SP 36 questionnary

Time Frame: Day 0 at the end of hospitalization, 6 months after hospitalization

Only the first two questions of the SF-36 are used exploring the felt quality of life at the time of the telephone call and in comparison with the period before hospitalization in intensive care.

Secondary Outcomes

  • Stress Assessment Questionnaire posttraumatic(Day 0 at the end of hospitalization, 6 months after hospitalization)
  • Assessment of independence in activities of daily life(Day 0 at the end of hospitalization, 6 months after hospitalization)

Study Sites (1)

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