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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 recomm
    Sponsor: Central Hospital, Nancy, France

    Current Primary Outcome: 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).


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Frequency of non epileptic seizures per month [ Time Frame: 24 months (average for 6 months) ]
      Seizures diaries follow
    • 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.
    • Psychiatric symptomology scores [ Time Frame: 24 months ]
      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 [ Time Frame: 24 months ]
      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 [ Time Frame: 24 months ]
      consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).


    Original Secondary Outcome: Same as current

    Information By: Central Hospital, Nancy, France

    Dates:
    Date Received: October 28, 2014
    Date Started: January 2014
    Date Completion: January 2018
    Last Updated: March 7, 2016
    Last Verified: March 2016