Study of the Social and Psychological Consequences of ICU Hospitalization
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 6, 2017
June 1, 2016
1.6 years
June 28, 2016
September 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of change of Life quality with SP 36 questionnary
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.
Day 0 at the end of hospitalization, 6 months after hospitalization
Secondary Outcomes (2)
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
Interventions
phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay. Investigators will use : * Questionnaire SF 36: 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. * Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R) * ADL: Assessment of independence in activities of daily life
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- Patient Do not speak French
- Patient aphasic deaf
- Patient with xxistencing cognitive disorders
- Homeless
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Study Officials
- PRINCIPAL INVESTIGATOR
GARROUSTE Maite, MD
Fondation Hôpital Saint-Joseph
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
June 30, 2016
Study Start
October 24, 2014
Primary Completion
May 30, 2016
Study Completion
June 1, 2017
Last Updated
September 6, 2017
Record last verified: 2016-06