Clinical trial NCT02311829: Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures
Official title: Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychogenic Non Epileptic Seizure
Keywords: Quality of life, PNES, Epilepsy,
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Dr Coraline HINGRAY
name: Pr Raymund SCHWAN
name: Dr Vincent LAPREVOTE
name: Dr Jean Pierre VIGNAL
name: Pr Hervé VESPIGNANI
name: Dr Anne THIRIAUX
name: Dr Delphine RAUCHER CHENE
name: Dr Martine LEMESLE
name: Dr Benoît TROJAK
name: Pr Edouard HIRSCH
name: Pr Pierre Vidailhet
name: Dr Dominique Mastelli
First posted: 2014-12-08
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.

Detailed description: This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.

Subject recruiting modalities:

The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.

Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.

Usual care:

After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.

In the study:

* For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
* For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.

Eligibility criteria: Inclusion Criteria:

* Patient above 18 years old
* Affiliation to social security
* Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
* Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
* Standardized announcement of the disease made by a neurologist participant / PHRC training
* Good understanding of the French language
* Patient consented to participate in the study

Exclusion Criteria:

* Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
* Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
* A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
* Simultaneous participation to another therapeutic intervention study during the first 12 months

Primary outcomes:
measure: Evolution of quality of life scores every 6 months (From 6 to 24 months)
timeFrame: 24 months
Secondary outcomes:
measure: Frequency of non epileptic seizures per month
timeFrame: 24 months (average for 6 months)
measure: Severity of seizures
timeFrame: 24 months
measure: Psychiatric symptomology scores
timeFrame: 24 months
measure: Percentage of programmed psychological consultation and actually honored in medical and psychological center
timeFrame: 24 months
measure: Number of urgent consultations or unprogrammed and \ or unprogrammed
timeFrame: 24 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Chu Strasbourg
state: Alsace
city: Dijon
country: France
facility: Chu Dijon
state: Bourgogne
city: Reims
country: France
facility: Chu Reims
state: Champagne Ardennes
city: Nancy
country: France
facility: Chu Nancy
state: Lorraine
Study officials:
affiliation: Central Hospital, Nancy, France
name: Louis MAILLARD, PU-PH, HDR
role: PRINCIPAL_INVESTIGATOR
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