Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Patient Reported Outcomes, Patient Satisfaction, Long Term Outcomes, Status Epilepticus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study
Overview
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 postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor 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. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.
Primary outcome measures
- percentage of global impairment of HRQoL [Time frame: at 3 month and 12 month]
Secondary outcome measures (9)
- percentage of cognitive impairment in patients managed in the ICU for or with SE [Time frame: at 3 month and 12 month]
- percentage of disability in patients managed in the ICU for or with SE [Time frame: at 3 month and 12 month]
- percentage of physical dependency in patients managed in the ICU for or with SE [Time frame: at 3 month and 12 month]
- percentage of anxiety and depression in patients managed in the ICU for or with SE [Time frame: at 3 month and 12 month]
- percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE [Time frame: at 3 month and 12 month]
- score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability. [Time frame: at 3 month and 12 month]
- Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE. [Time frame: at 3 month and 12 month]
- patient's experience of the care system. [Time frame: at 3 month and 12 month]
- experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME. [Time frame: at 3 month and 12 month]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Legal guardianship
- Opposition to participate
- Unread and unwritten French language
- Patient not affiliated to a Social Security system
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 19 centers
- CH d'Angoulême — Angoulême
- CH d'Arras — Arras
- CHU de Besançon — Besançon
- CH de Béthune — Béthune
- CHU de Brest — Brest
- CH de Cannes — Cannes
- Hôpital Beaujon — Clichy
- Hôpital Henri Mondor — Créteil
- … and 11 more centers
Publications
- Legriel S, Bernard C, Sboui G, Sigaud F, Lascarrou JB, Mayenco-Cardenal N, Chelly J, Bruel C, Mongardon N, Marzouk M, Quenot JP, Hugues R, Schnell D, Beuret P, Bailly P, Lesieur O, Argaud L, Chambon R, Jacq G. Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre lon PMID 41775483
Identifiers
NCT: NCT06100978 · P22/08 - POSEIDON 2