Patient Reported OutcomesPOSEIDONNCT05491590
Patient-reported Outcome After Status Epilepticus
An observational study of Patient Reported Outcomes and Long Term Outcomes, run by Versailles Hospital at 16 sites in France.
Trial summary
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcomes, Long Term Outcomes, Status Epilepticus
- How many people
- 66 participants
- Where
- 16 sitesFrance
- Study dates
- 15 Nov 2022to 10 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the eligibility criteria will be offered participation in the study.
Who may be able to join
- Adults 18 years old or older
- Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
- Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge
Who cannot join
- Legal guardianship
- Opposition to participate
- Unread and unwritten French language
- Patient not affiliated to a Social Security system
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CH de Bethune
Beuvry, 62660
CHU de Brest
Brest, 29200
CH de Brive la Gaillarde
Brive-la-Gaillarde, 19100
CH de Cannes
Cannes, 06414
CH du Cotentin
Cherbourg, 50102
CHU de Beaujon
Clichy, 92110
CHU Henri Mondor
Créteil, 94010
CHU de Dijon
Dijon, 21079
CH de la Rochelle
La Rochelle, 17019
CHVersailles
Le Chesnay, Yvelines, 78150
GH Sud Ile de France
Melun, 77000
CHU de Nantes
Nantes, 44093
GH Paris Saint Joseph
Paris, 75014
Hôpital Claude Galien
Quincy-sous-Sénart, 91480
CH de Roanne
Roanne, 42328
CH de Toulon-La Seyne sur Mer
Toulon, 83056
About this study
Official title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments.
The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied.
Read more
Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.
Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.
- Conditions
- Patient Reported Outcomes, Long Term Outcomes, Status Epilepticus, Intensive Care Unit, Intensive Care Unit Syndrome
- Medical subject headings
- Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE.
36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
Measured: one day
Secondary outcomes (8)
percentage of cognitive/physical and/or mental health impairment defined after dichotomization of i)T-MoCA ,ii) GOS, iii)IADL&ADL, iv)HAD, v)IES-r in patients managed in the ICU for or with SE
- i)The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considerednormal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
- ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap
- iii) The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Each ability measured by the scale relies on either cognitive or physical function, though all require some degree of both.
- and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
- iv)The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety
- v)The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD
Measured: one day
percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31 in patients managed in intensive care for or with SE.
-QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status.
Measured: one day
percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31in the SE sub-groups defining (with or without predominant motor signs)
- 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
- QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status.
Measured: one day
Presence or absence Post-ICU factors associed to the PICs, as defined above in patients managed in the ICU for or with SE.
cf outcomes 2
Measured: one day
Presence or absence of the elements associated with the PICs, as defined above, in the subgroups defining SE (SE with orwithout predominant motor signs,).
- i)The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considerednormal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
- ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap
- iii) The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Each ability measured by the scale relies on either cognitive or physical function, though all require some degree of both.
- and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
- iv)The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety
- v)The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD
Measured: one day
Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
A return to work or school will be interpreted by the structured GOS interview.
Measured: one day
score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
The Social Support Questionnaire- Short Form-SSQ6 / 6 item measure of social support, with scores ranging from 0 (no social support) to 6 (very high social) and 1 (very dissatisfied) to 6 (very satisfied) for the area of satisfaction in each item or area. From these scores in the 6 domains, an average score was calculated for the number of supports available -Ranging score[0-54] and for satisfaction.Ranging score[0-36]
Measured: one day
percentage of the quality of life impairement in the total population and in in the SE sub-groups patients identified with an previous epilepsy
- 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
- QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start15 Nov 2022
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported OutcomesStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacq Gwenaelle, Versailles Hospital
- Investigators
- Gwenaelle JACQ, RN,MSc,PhDc, Principal investigator, Versailles HospitalStephane LEGRIEL, MD,PhD, Study director, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491590
- Sponsor's protocol ID
- P21/11 - POSEIDON
- Acronym
- POSEIDON
- Status last verified
- Nov 2024
- First submitted
- 1 Aug 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management
- ClinicalTrials.gov ID
- NCT05491590
- Acronym / sponsor ID
- POSEIDON / P21/11 - POSEIDON
- Conditions
- Patient Reported Outcomes, Long Term Outcomes, Status Epilepticus, Intensive Care Unit, Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- 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.
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments.
The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied.
Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.
Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the eligibility criteria will be offered participation in the study.
Key inclusion criteria (3 listed)
- Adults 18 years old or older
- Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
- Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge
Key exclusion criteria (4 listed)
- Legal guardianship
- Opposition to participate
- Unread and unwritten French language
- Patient not affiliated to a Social Security system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE.
Time frame: one day
36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
8 secondary outcomes
percentage of cognitive/physical and/or mental health impairment defined after dichotomization of i)T-MoCA ,ii) GOS, iii)IADL&ADL, iv)HAD, v)IES-r in patients managed in the ICU for or with SE
Time frame: one day
percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31 in patients managed in intensive care for or with SE.
Time frame: one day
percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31in the SE sub-groups defining (with or without predominant motor signs)
Time frame: one day
Presence or absence Post-ICU factors associed to the PICs, as defined above in patients managed in the ICU for or with SE.
Time frame: one day
Presence or absence of the elements associated with the PICs, as defined above, in the subgroups defining SE (SE with orwithout predominant motor signs,).
Time frame: one day
Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
Time frame: one day
score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
Time frame: one day
percentage of the quality of life impairement in the total population and in in the SE sub-groups patients identified with an previous epilepsy
Time frame: one day
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 26 Nov 2024.
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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.
Gwenaelle JACQ, RN,MSc,PhDc principal investigator
Versailles Hospital
Stephane LEGRIEL, MD,PhD study director
Versailles Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcomes and Long Term Outcomes, run by Versailles Hospital at 16 sites 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 3 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE. (time frame: one day). 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 26 Nov 2024.