Evaluating the Efficacy of a Mobile Epilepsy Education Application

October 2, 2025 updated by: Kenneth Myers, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute of the McGill University Health Centre
      • Montreal, Quebec, Canada, H4A 3J1
        • Montreal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Epilepsy Education Package
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.
Other: Mobile Epilepsy Education Package

MEEP education section contains a range of topics. After completing the relevant section at the end of each week, participants complete the end-of-section test and switch to the next week's topic. Completion of the first part will take approximately 90-120 minutes per week for a total of 4 weeks of use.

Parental Monitoring Section, parents can actively record information on the mobile application related to their child's diagnosis (anonymous); treatments; timing and frequency of the seizures; and appointments; and schedule treatment and examination reminders to optimize compliance. Completion of this second part will take approximately 1-2 minutes and depends on the parental choice to use and how much information they would like to share. The second part, together with the first part, will be evaluated for a total of 1 month.
Other: Standard care consisting of epilepsy education
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.
Other: Standard care consisting of epilepsy education
This standard care includes the information and education provided by nurses and physicians during visits and hospitalisations. Standard information and education include topics such as: counseling by the neurologist regarding seizure safety precautions, prognosis, and sudden unexpected death in epilepsy (SUDEP); provision of paper or electronic resources regarding epilepsy; and telephone support provided by neurology clinic nurse regarding any issues or concerns). Information and education is usually provided orally and through printed brochures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package
Time Frame: 7 weeks
This will be assessed using the "Epilepsy Knowledge Scale for Parents." This scale consists of 20 questions including the cause of seizures, emergency care, complications of seizures, cognitive and psychosocial consequences and limitations. In scoring the items in the scale, False means "0" and True means "1". A score between 0-20 can be obtained from the scale. A high total score indicates that parents have a high level of knowledge about epilepsy.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education
Time Frame: 7 weeks
This will be assessed with the "Parental Anxiety Scale for Seizures." This scale consists of 9 items in 5-point Likert type. Each item in the scale is scored between 1 and 5. A score between 9 and 45 can be obtained from the scale. A high total score indicates that parents have low anxiety about seizures.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Kenneth Alexis Myers, MD PhD FRCPC, RI-MUHC, Montreal Children's Hospital, McGill University
  • Study Chair: Dilek Sayik, RN, PhD, Ingram School of Nursing, McGill University
  • Study Chair: Ayfer Acikgoz, RN, PhD, Faculty of Health Sciences, Eskisehir Osmangazi University
  • Study Chair: Argerie Tsimicalis, RN, PhD, Shriners Hospitals for Children, Ingram School of Nursing, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEA-EE (2024-10228)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share study protocol, materials (eg consent form, recruitment flyers). App will be available in the future for free download.

IPD Sharing Time Frame

It is completed December 2024.

IPD Sharing Access Criteria

The study protocol will be published in a journal. ICF can be requested from the author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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