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Completed

NCT Number: NCT06402526

Evaluating the Efficacy of a Mobile Epilepsy Education Application

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.

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Key information

Conditions

Epilepsy Anxiety Anxiety Disorders Behavior Brain Diseases Central Nervous System Diseases Epilepsy in Children Knowledge, Attitudes, Practice Mental Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Children's Hospital, Montreal, Quebec, Canada

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About this study

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

  • To determine whether MEEP used by parents/caregivers of children with epilepsy reduces their anxiety about epilepsy.
  • To determine whether there is an increase in adherence to treatment by using the following MEEP features:
  • "treatment/exam control time reminder" tab in the "follow-up section" of MEEP; and
  • 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:

  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Epilepsy Education Package

Other

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.

Standard care consisting of epilepsy education

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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