Image

Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

Recruiting
18 - 40 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details

Epilepsy

NCT06202196

University Hospital, Montpellier

1 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.