Other Clinical Trial - Evaluation of a Telephone Follow-up NCT02311829

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT02311829
Other study ID #	2012-A01580-43
Secondary ID
Status	Recruiting
Phase	N/A
First received	October 28, 2014
Last updated	March 7, 2016
Start date	January 2014
Est. completion date	January 2018

Study information
Verified date	March 2016
Source	Central Hospital, Nancy, France
Contact	Louis MAILLARD, PU-PH, HDR
Phone	03 83 85 16 86
Email	l.maillard[@]chu-nancy.fr
Is FDA regulated	No
Health authority	France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type	Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status	Recruiting
Enrollment	136
Est. completion date	January 2018
Est. primary completion date	January 2018
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Psychogenic Non Epileptic Seizure
Seizures

Intervention

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.

Locations
Country	Name	City	State
France	Chu Dijon	Dijon	Bourgogne
France	Chu Nancy	Nancy	Lorraine
France	Chu Reims	Reims	Champagne Ardennes
France	Chu Strasbourg	Strasbourg	Alsace

Sponsors *(13)*
Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Dr Anne THIRIAUX, Dr Benoît TROJAK, Dr Coraline HINGRAY, Dr Delphine RAUCHER CHENE, Dr Dominique Mastelli, Dr Jean Pierre VIGNAL, Dr Martine LEMESLE, Dr Vincent LAPREVOTE, Pr Edouard HIRSCH, Pr Hervé VESPIGNANI, Pr Pierre Vidailhet, Pr Raymund SCHWAN

Country where clinical trial is conducted

France,

References & Publications (64)

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* Note: There are 64 references in all — Click here to view all references

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Frequency of non epileptic seizures per month	Seizures diaries follow	24 months (average for 6 months)	No
Secondary	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	No
Secondary	Psychiatric symptomology scores	Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE)	24 months	No
Secondary	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	No
Secondary	Number of urgent consultations or unprogrammed and \ or unprogrammed	consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).	24 months	No

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (13)

Country where clinical trial is conducted

References & Publications (64)

Outcome