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

Primary Purpose

Psychogenic Non Epileptic Seizure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telephone follow-up device
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychogenic Non Epileptic Seizure focused on measuring Quality of life, PNES, Epilepsy,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu StrasbourgRecruiting
  • Chu DijonRecruiting
  • Chu ReimsRecruiting
  • Chu NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone follow-up device (DST)

Group control ; usual care

Arm Description

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.

- 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Frequency of non epileptic seizures per month
Seizures diaries follow
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.
Psychiatric symptomology scores
Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE)
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)
Number of urgent consultations or unprogrammed and \ or unprogrammed
consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).

Full Information

First Posted
October 28, 2014
Last Updated
March 7, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
Dr Coraline HINGRAY, Pr Raymund SCHWAN, Dr Vincent LAPREVOTE, Dr Jean Pierre VIGNAL, Pr Hervé VESPIGNANI, Dr Anne THIRIAUX, Dr Delphine RAUCHER CHENE, Dr Martine LEMESLE, Dr Benoît TROJAK, Pr Edouard HIRSCH, Pr Pierre Vidailhet, Dr Dominique Mastelli
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1. Study Identification

Unique Protocol Identification Number
NCT02311829
Brief Title
Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures
Acronym
EDUQ-CPNE
Official Title
Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Dr Coraline HINGRAY, Pr Raymund SCHWAN, Dr Vincent LAPREVOTE, Dr Jean Pierre VIGNAL, Pr Hervé VESPIGNANI, Dr Anne THIRIAUX, Dr Delphine RAUCHER CHENE, Dr Martine LEMESLE, Dr Benoît TROJAK, Pr Edouard HIRSCH, Pr Pierre Vidailhet, Dr Dominique Mastelli

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Non Epileptic Seizure
Keywords
Quality of life, PNES, Epilepsy,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telephone follow-up device (DST)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group control ; usual care
Arm Type
No Intervention
Arm Description
- 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.
Intervention Type
Other
Intervention Name(s)
Telephone follow-up device
Intervention Description
For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
Primary Outcome Measure Information:
Title
Evolution of quality of life scores every 6 months (From 6 to 24 months)
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Frequency of non epileptic seizures per month
Description
Seizures diaries follow
Time Frame
24 months (average for 6 months)
Title
Severity of seizures
Description
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.
Time Frame
24 months
Title
Psychiatric symptomology scores
Description
Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE)
Time Frame
24 months
Title
Percentage of programmed psychological consultation and actually honored in medical and psychological center
Description
This percentage is collected in medical and psychological center or from liberal psychiatrist \ psychologist (collected with phone call)
Time Frame
24 months
Title
Number of urgent consultations or unprogrammed and \ or unprogrammed
Description
consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis MAILLARD, PU-PH, HDR
Phone
03 83 85 16 86
Ext
+33
Email
l.maillard@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Coraline HINGRAY, PU-PH
Phone
03 83 85 16 86
Ext
+33
Email
c.hingray@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis MAILLARD, PU-PH, HDR
Organizational Affiliation
Central Hospital, Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Strasbourg
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67 098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard HIRSCH, MD PHD
Phone
03 88 11 67 68
Ext
+33
Email
Edouard.hirsch@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Pierre VIDAILHET, MD PHD
Phone
03 88 11 67 68
Ext
+33
Email
Pierre.VIDAILHET@chru-strasbourg.fr
Facility Name
Chu Dijon
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21 079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine LEMESLE, MD
Phone
03 80 29 37 54
Ext
+33
Email
martine.lemesle@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Benoît TROJAK, MD PHD
Phone
03 80 29 37 54
Ext
+33
Email
benoit.trojak@chu-dijon.fr
Facility Name
Chu Reims
City
Reims
State/Province
Champagne Ardennes
ZIP/Postal Code
51 092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne THIRIAUX, MD
Phone
03 26 78 71 34
Ext
+33
Email
thiriauxanne@hotmail.com
First Name & Middle Initial & Last Name & Degree
Delphine RAUCHER CHENE, MD
Phone
03 26 78 71 34
Ext
+33
Email
draucherchene@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Jean François VISSEAUX, MD
Facility Name
Chu Nancy
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54 035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis MAILLARD, MD PHD
Phone
03 83 85 16 86
Ext
+33
Email
l.maillard@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Coraline HINGRAY, MD
Phone
03 83 85 16 86
Ext
+33
Email
c.hingray@chu-nancy.fr

12. IPD Sharing Statement

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

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