Intensive Care UnitsNCT02819154
Study of the Social and Psychological Consequences of ICU Hospitalization
An observational study of Intensive Care Units, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Units
- What is being tested?
- phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient Do not speak French
- Patient aphasic deaf
- Patient with xxistencing cognitive disorders
- Homeless
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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
- Conditions
- Intensive Care Units
- Being tested
- phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stayBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 at the end of hospitalization, 6 months after hospitalization
Secondary outcomes (2)
Stress Assessment Questionnaire posttraumatic
Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)
Measured: Day 0 at the end of hospitalization, 6 months after hospitalization
Assessment of independence in activities of daily life
ADL: Assessment of independence in activities of daily life
Measured: Day 0 at the end of hospitalization, 6 months after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start24 Oct 2014
- Primary completion30 May 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GARROUSTE Maite, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819154
- Sponsor's protocol ID
- SEPPICC
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Social and Psychological Consequences of ICU Hospitalization
- ClinicalTrials.gov ID
- NCT02819154
- Acronym / sponsor ID
- SEPPICC
- Conditions
- Intensive Care Units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Patient Do not speak French
- Patient aphasic deaf
- Patient with xxistencing cognitive disorders
- Homeless
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stayphone 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 | Behavioural | – |
Primary outcome
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.
2 secondary outcomes
Stress Assessment Questionnaire posttraumatic
Time frame: Day 0 at the end of hospitalization, 6 months after hospitalization
Assessment of independence in activities of daily life
Time frame: Day 0 at the end of hospitalization, 6 months after hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GARROUSTE Maite, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of Life quality with SP 36 questionnary (time frame: Day 0 at the end of hospitalization, 6 months after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.