Prognostic Outcome Score in Functional Neurological Disorders

NCT05003557 | Completed

• 2 other identifiers: 38RC21.1672021-A01181-40
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care. The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records. The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present. Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.

Conditions

Functional Neurological Symptom Disorder

Keywords

psychogenic

Outcome Measures

Primary Outcomes (1)

• Clinical evolution according the Clinical Global Impression scale

  Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations)

  continuously through study completion, an average of 1 year

Secondary Outcomes (2)

• Quality of life of each patient

  continuously through study completion, an average of 1 year

• Illness perception as reported by each patient

  continuously through study completion, an average of 1 year

Interventions

Questionnaire administration OTHER

3 different questionnaires are going to be administered to each participant, * concerning the current health situation * the SF 36 * the IPQ-R questionnaire

Eligibility Criteria

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

Study Population

patients hospitalized in neurology ward from 2012 to 2015 and presenting with FND

You may qualify if:

• Male or female gender
• Hospitalization in Neurology Department A from 2012 to 2015 with a final retained diagnosis of NFT
• POS score at time of hospitalization available

You may not qualify if:

• Patient under legal protection
• Inability to complete a self-questionnaire
• Minor subjects

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Laurent Vercueil, MD; PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 12, 2021
• Study Start: January 5, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)