NCT06100978 Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
| NCT ID | NCT06100978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Versailles Hospital |
| Condition | Patient Reported Outcomes |
| Study Type | OBSERVATIONAL |
| Enrollment | 145 participants |
| Start Date | 2024-05-25 |
| Primary Completion | 2027-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 145 participants in total. It began in 2024-05-25 with a primary completion date of 2027-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Gwenaelle Jacq, RN,MSc,PhDc
STUDY DIRECTOR
CH Versailles
Frequently Asked Questions
Who can join the NCT06100978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient Reported Outcomes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06100978 currently recruiting?
Yes, NCT06100978 is actively recruiting participants. Contact the research team at gjacq@ght78sud.fr for enrollment information.
Where is the NCT06100978 trial being conducted?
This trial is being conducted at Angoulême, France, Arras, France, Besançon, France, Béthune, France and 11 additional locations.
Who is sponsoring the NCT06100978 clinical trial?
NCT06100978 is sponsored by Versailles Hospital. The principal investigator is Gwenaelle Jacq, RN,MSc,PhDc at CH Versailles. The trial plans to enroll 145 participants.