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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Psychogenic Non Epileptic Seizure

Treatments: Other: Telephone follow-up device

Study type: Interventional

Funder types: Other

Identifiers

NCT02311829

2012-A01580-43

Details and patient eligibility

About

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

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Telephone follow-up device (DST)

Experimental group

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.

Treatment:

Other: Telephone follow-up device

Group control ; usual care

No Intervention group

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.