NCT02819154

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

June 28, 2016

Last Update Submit

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Location

Study Officials

  • GARROUSTE Maite, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

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

Locations