Study of the Social and Psychological Consequences of ICU Hospitalization

Intensive Care Units Clinical Trial

Official title:

Study of the Social and Psychological Consequences of ICU Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819154
• Other study ID #: SEPPICC
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: September 4, 2017
• Start date: October 24, 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Units

Intervention

Behavioral:
• phone 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

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stress Assessment Questionnaire posttraumatic	Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)	Day 0 at the end of hospitalization, 6 months after hospitalization
Secondary	Assessment of independence in activities of daily life	ADL: Assessment of independence in activities of daily life	Day 0 at the end of hospitalization, 6 months after hospitalization