CClinicalTrials.gg
CompletedNCT02819154Updated Sep 6, 2017

Study of the Social and Psychological Consequences of ICU Hospitalization

An observational study in Intensive Care Units, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Intensive Care Units
03

In context

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Patient Do not speak French
  • Patient aphasic deaf
  • Patient with xxistencing cognitive disorders
  • Homeless
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Stress Assessment Questionnaire posttraumatic

    Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)

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

  2. Assessment of independence in activities of daily life

    ADL: Assessment of independence in activities of daily life

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

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile de France 75014, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02819154
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Oct 24, 2014
Primary completion
May 30, 2016
Completion
Jun 2017
Last update
Sep 6, 2017

Study contacts

GARROUSTE Maite, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion