Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

NCT06100978 | Recruiting

• 1 other identifier: P22/08 - POSEIDON 2
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 13

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.

Conditions

Patient Reported Outcomes; Patient Satisfaction; Long Term Outcomes; Status Epilepticus; Intensive Care Unit; Burden; Relatives

Outcome Measures

Primary Outcomes (1)

• percentage of global impairment of HRQoL

  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.

  at 3 month and 12 month

Secondary Outcomes (9)

• percentage of cognitive impairment in patients managed in the ICU for or with SE

  at 3 month and 12 month

• percentage of disability in patients managed in the ICU for or with SE

  at 3 month and 12 month

• percentage of physical dependency in patients managed in the ICU for or with SE

  at 3 month and 12 month

• percentage of anxiety and depression in patients managed in the ICU for or with SE

  at 3 month and 12 month

• percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE

  at 3 month and 12 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who meet the eligibility criteria will be offered participation in the study.

You may qualify if:

• 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

You may not qualify if:

• Legal guardianship
• Opposition to participate
• Unread and unwritten French language
• Patient not affiliated to a Social Security system

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (13)

CH d'Angoulême

Angoulême, France

RECRUITING

CH de Béthune

Béthune, France

RECRUITING

Hôpital Beaujon

Clichy, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

CHU de Dijon

Dijon, France

RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

CH de La Rochelle

La Rochelle, France

RECRUITING

CH Versailles

Le Chesnay, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Hôpital Paris Saint Joseph

Paris, France

NOT YET RECRUITING

CH de Roanne

Roanne, France

RECRUITING

Hôpital Foch

Suresnes, France

NOT YET RECRUITING

CHU Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Status Epilepticus

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gwenaelle Jacq, RN,MSc,PhDc

  CH Versailles

  STUDY DIRECTOR

• Stephane Legriel, MD,PhD

  CH Versailles

  STUDY DIRECTOR

Central Study Contacts

Gwenaelle Jacq, RN,MSc,PhDc

CONTACT

33139638356; gjacq@ght78sud.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordinator

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 25, 2023
• Study Start: May 25, 2024
• Primary Completion: May 25, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

FR (13)