Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures

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

Detailed Description
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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.

Official Title
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Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.

Conditions
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Psychogenic Non Epileptic Seizure

Intervention / Treatment
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* Other: Telephone follow-up device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone follow-up device (DST)<br>An external independent clinical psychologist is responsible for calling regular the patient included in DST-arm. Telephone follow-up device(DST) consists of telephone calls at 15 day, 2 month and then every 2 months until 12 months. The clinical psychologist is 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. | Other: Telephone follow-up device<br>* For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.<br>|
| No Intervention: Group control ; usual care<br>- Usual care: After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannually with the neurologist - For patients in both groups: in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannual for 24 months after the appointment with the neurologist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of quality of life scores every 6 months (From 6 to 24 months) | The primary endpoint is the assessment of quality of life scores measured at 6, 12, 18 and 24 months after start of treatment (visit D0) by self-administered questionnaires of quality of life (SF-36 general questionnaire quality of life) and QOLIE 31 (specific questionnaire epilepsy). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of non epileptic seizures per month | Seizures diaries follow | 24 months (average for 6 months) | 
| Severity of seizures | Duration, injuries, loss of urine and feces, fall, loss of consciousness and subjective control feel of the listed crisis between 0 and 10 on EVA scale crisis control feel. | 24 months | 
| Psychiatric symptomology scores | Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE) | 24 months | 
| Percentage of programmed psychological consultation and actually honored in medical and psychological center | This percentage is collected in medical and psychological center or from liberal psychiatrist \ psychologist (collected with phone call) | 24 months | 
| Number of urgent consultations or unprogrammed and \ or unprogrammed | consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, PNES, Epilepsy,