Study of the Social and Psychological Consequences of ICU Hospitalization

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.

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Key information

Conditions

Intensive Care Units

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

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

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

Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)
Assessment of independence in activities of daily life

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

ADL: Assessment of independence in activities of daily life

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Jun 30, 2016
Registry last updated: Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed