Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy (EPI-RISK)

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University Hospital Center (CHU)

Status

Enrolling

Conditions

Epilepsy

Treatments

Procedure: Usual Therapeutic Patient Education (TPE) management
Procedure: Risk prevention session

Study type

Interventional

Funder types

Other

Identifiers

NCT06202196
RECHMPL18_0196

Details and patient eligibility

About

Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE). 37 subjects per group will be included in this study.

Full description

The study will be proposed to patients with uncontrolled epilepsy (n=74) aged 18 to 40. The investigators will evaluate 3 months after the last therapeutic patient session, the impact of the epilepsy-related risk prevention system on the self-management of epilepsy ("Safety Management" score of the Epilepsy Self Management Scale (ESMS). This scale has 5 dimensions (5 sub-scores): treatment management, information management, safety management, seizure management and lifestyle management. Each clinical investigation team works in collaboration with a clinical psychologist for psychological assessment interviews. The implementation of such a plan should enable patient to acquire so-called safety skills aimed at protecting his life, reducing risky behavior and increasing medication compliance.

Enrollment

74 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient between 18 and 40 years old
  • Patient with poorly controlled epilepsy (persistence of seizures evolving for more than a year despite proper treatment).
  • Patient agreeing to participate in a therapeutic education program (TPE)

Exclusion criteria

  • Epileptic patient with an intellectual deficit
  • Epileptic patient who has already benefited from a TPE epilepsy program
  • Patient deprived of liberty by court or administrative decision, subject to a legal protection measure (guardianship or curatorship)
  • Failure to obtain written informed consent after a reflection period
  • Patient who for geographical, social or psychological reasons could not participate in the research
  • Any situation that, in the opinion of the investigator, could present risks to the patient and to the research
  • Participation in another therapeutic research
  • Subjects not covered by public health insurance

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Experimental group
Experimental group
Description:
Patients of the experimental group will have therapeutic patient education sessions that include one "Recognizing and Managing the Risks of Epilepsy" workshop.
Treatment:
Procedure: Risk prevention session
Control group "Usual management"
Other group
Description:
Patients of the "control" group will have the usual therapeutic patient education sessions.
Treatment:
Procedure: Usual Therapeutic Patient Education (TPE) management

Trial contacts and locations

1

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Central trial contact

Christiane Maurin, Nurse

Data sourced from clinicaltrials.gov

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