Evaluating the Efficacy of a Mobile Epilepsy Education Application

Anxiety Clinical Trial

Official title: Unicentre Parallel Open Randomized Trial to Evaluate the Efficacy of a Mobile Epilepsy Education Application Developed For The Parents/Caregivers of Children With Epilepsy in Canada

Status Not yet recruiting

Clinical Trial Summary

Background. Following a childhood diagnosis of epilepsy, children and their families encounter significant concerns about the disease trajectory, side effects of anti-seizure medications, and long-term prognosis. The multitude of uncertainties can cause significant anxiety in the family, often within the context of limited supports and resources. Epilepsy education can help address these concerns, mitigating the development of anxiety, ultimately leading to better patient-, family- and system-level outcomes. Globally, the MEEP is the only mobile application providing education, monitoring of symptoms, and tracking of medical appointments. The original MEEP was developed, tested, and integrated into practice in Turkey; the investigators will now evaluate the efficacy of an English and French version of the MEEP for families of children with epilepsy in Canada.

A two-group, single-center, randomized controlled intervention trial with 1:1 allocation ratio will be conducted in the Pediatric Neurology Clinic of the Montreal Children's Hospital. Seventy-two caregivers of children with epilepsy (intervention=36, control= 36), aged 1-17 years and treated at the study site will be eligible. Family Introduction Form, Epilepsy Information Scale for Parents and Parental Anxiety Scale for Seizures will be used to collect data at baseline and 3 weeks post-delivery of the 7-week intervention. The MEEP consists of 2 parts. The first part entails the delivery of the educational content of the MEEP, and the second part consists of a "Parental Monitoring Section." Comparator. The control group will continue to benefit from the standard educational services provided by the study site.

Clinical Trial Description

OBJECTIVES:

Evaluate the efficacy of an English and French version of the Mobile Epilepsy Education Package (MEEP) for parents/caregivers of children with epilepsy in Canada.

Primary Objective:

To determine whether the MEEP used by parents/caregivers with children diagnosed with epilepsy increases the level of knowledge about epilepsy.

Secondary Objectives

1. To determine whether MEEP used by parents/caregivers of children with epilepsy reduces their anxiety about epilepsy.

2. To determine whether there is an increase in adherence to treatment by using the following MEEP features:

1. "treatment/exam control time reminder" tab in the "follow-up section" of MEEP; and

2. data on app usage (number of logins, time spent on app).

Primary and Secondary Endpoints/Outcome Measures The primary outcome is epilepsy knowledge and will be assessed using the " Epilepsy Knowledge Scale for Parents." The secondary outcome is parental anxiety and will be assessed with the "Parental Anxiety Scale for Seizures."

Other secondary outcomes are:

1. To determine whether there is an increase in adherence to treatment by using the "treatment/exam control time reminder" tab in the "follow-up section" of MEEP.

2. To determine whether there is an increase in adherence to treatment by using the data on app usage (number of logins, time spent on app). ;

Related Conditions & MeSH terms

• Anxiety
• Epilepsy
• Epilepsy in Children
• Knowledge, Attitudes, Practice

• NCT number: NCT06402526
• Study type: Interventional
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Kenneth Alexis Myers, MD PhD FRCPC
• Phone: 514-934-1934
• Email: kenneth.myers@mcgill.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: September 30, 2026