Evaluating the Efficacy of a Mobile Epilepsy Education Application

McGill University

Status: Completed

Conditions: Epilepsy; Knowledge, Attitudes, Practice; Anxiety; Epilepsy in Children

Treatments: Other: Standard care consisting of epilepsy education; Other: Mobile Epilepsy Education Package

Study type: Interventional

Funder types: Other

Identifiers

NCT06402526

MEA-EE (2024-10228)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parents/caregivers whose children are between 1-17 years old;
• Parents/caregivers whose child was diagnosed with epilepsy at least 2 months ago;
• At least one primary caregiver is comfortable interacting in English or French; and
• At least one primary caregiver owns and uses a smartphone on a daily basis.

Exclusion criteria

- Inability to provide informed consent for any reason.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Mobile Epilepsy Education Package

Experimental group

Description:

The Mobile Epilepsy Education Package (MEEP) consists of 2 parts. The first part entails the delivery of the "MEEP education", and the second part consists of the "Parental Monitoring Section". The intervention group will use MEEP for 4 weeks.

Treatment:

Other: Mobile Epilepsy Education Package

Standard care consisting of epilepsy education

Other group

Description:

Standard care consisting of epilepsy education and support offered at the study setting by members of the Pediatric Neurology Clinic was chosen as the comparator and serves as the control group.

Treatment:

Other: Standard care consisting of epilepsy education