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Study of the Social and Psychological Consequences of ICU Hospitalization

Study of the Social and Psychological Consequences of ICU Hospitalization

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02819154
Enrollment
100
Registered
2016-06-30
Start date
2014-10-24
Completion date
2017-06-30
Last updated
2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units

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

Interventions

BEHAVIORALphone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay

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

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of change of Life quality with SP 36 questionnaryDay 0 at the end of hospitalization, 6 months after hospitalizationOnly 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

MeasureTime frameDescription
Stress Assessment Questionnaire posttraumaticDay 0 at the end of hospitalization, 6 months after hospitalizationStress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)
Assessment of independence in activities of daily lifeDay 0 at the end of hospitalization, 6 months after hospitalizationADL: Assessment of independence in activities of daily life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026