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

March 7, 2016 updated by: Central Hospital, Nancy, France

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Alsace
    • Bourgogne
    • Champagne Ardennes
      • Reims, Champagne Ardennes, France, 51 092
        • Recruiting
        • CHU Reims
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jean François VISSEAUX, MD
    • Lorraine
      • Nancy, Lorraine, France, 54 035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone follow-up device (DST)

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
For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
No Intervention: Group control ; usual care

- 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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of quality of life scores every 6 months (From 6 to 24 months)
Time Frame: 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
Time Frame: 24 months (average for 6 months)
Seizures diaries follow
24 months (average for 6 months)
Severity of seizures
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Louis MAILLARD, PU-PH, HDR, Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01580-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychogenic Non Epileptic Seizure

Clinical Trials on Telephone follow-up device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe