Mobile Education App for Childhood Epilepsy

No longer recruiting at 3 trial locations

Overseen By Dilek Sayik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Inability to provide informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help families manage childhood epilepsy. The app, called the Mobile Epilepsy Education Package (MEEP or Mobile Epilepsy Education Application), provides educational content and tools for tracking symptoms and medical appointments. Researchers aim to determine if this app can reduce anxiety and improve outcomes for families managing epilepsy. Eligible families have children aged 1-17 who were diagnosed with epilepsy at least two months ago and regularly use a smartphone. Participants will either use this app or receive standard epilepsy education from the hospital. As an unphased trial, this study allows families to contribute to innovative research that could enhance epilepsy management and support.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this mobile education app is safe for children with epilepsy?

Research has shown that the Mobile Epilepsy Education Package (MEEP) helps parents learn more about epilepsy and reduces anxiety. In Turkey, the app has been used successfully, yielding positive results without any reported safety concerns. As an educational tool, MEEP does not involve medication or medical procedures, thus minimizing the risk of side effects.

The primary goal of the MEEP app is to provide information and support to families managing childhood epilepsy. It educates caregivers, boosting their confidence in handling their child's condition. Due to its educational focus, it is generally well-received and avoids the side effects associated with medications or invasive treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Epilepsy Education Package (MEEP) for childhood epilepsy because it introduces a new way of supporting children and their families through an accessible mobile app. Unlike traditional education methods that rely on in-person consultations, MEEP offers a convenient digital platform that includes both educational content and a parental monitoring section. This approach not only empowers parents with knowledge but also allows for real-time monitoring and management of their child’s condition, potentially improving outcomes and reducing the stress associated with managing epilepsy.

What evidence suggests that the Mobile Epilepsy Education Package is effective for childhood epilepsy?

Research has shown that the Mobile Epilepsy Education Package (MEEP), which participants in this trial may receive, helps parents learn more about epilepsy and feel less anxious. Studies have found that parents using MEEP gain a better understanding of epilepsy-related issues. This app also reduces the worry parents often have about their child's condition. In one study, researchers adapted MEEP for use in Canada and observed similar positive results. Overall, MEEP provides an easy and straightforward way for parents to access important information and support. ^{1 2 4 5 6}

Who Is on the Research Team?

Kenneth Alexis Myers, MD PhD FRCPC

Principal Investigator

RI-MUHC, Montreal Children's Hospital, McGill University

Dilek Sayik, RN, PhD

Principal Investigator

Ingram School of Nursing, McGill University

Ayfer Acikgoz, RN, PhD

Principal Investigator

Faculty of Health Sciences, Eskisehir Osmangazi University

Argerie Tsimicalis, RN, PhD

Principal Investigator

Shriners Hospitals for Children, Ingram School of Nursing, McGill University

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged 1-17 with epilepsy treated at the Montreal Children's Hospital. It aims to help families manage anxiety and improve knowledge about epilepsy through a mobile app. Participants must be able to use the app in English or French.

Inclusion Criteria

I am a parent/caregiver of a child aged 1-17.

At least one primary caregiver owns and uses a smartphone on a daily basis

My primary caregiver is comfortable with English or French.

Exclusion Criteria

Inability to provide informed consent for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Mobile Epilepsy Education Package (MEEP) for 4 weeks, which includes educational content and a Parental Monitoring Section

4 weeks

Follow-up

Participants are monitored for changes in epilepsy knowledge and anxiety levels after the intervention

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Epilepsy Education Package

Trial Overview The study tests a Mobile Epilepsy Education Package (MEEP) against standard care. MEEP provides education, symptom monitoring, and appointment tracking via an app. Caregivers are randomly assigned to either receive MEEP or continue with usual educational services.

How Is the Trial Designed?

Group I: Standard care consisting of epilepsy education Experimental Treatment 1 Intervention

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.

Group II: Mobile Epilepsy Education Package Experimental Treatment 1 Intervention

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.

Mobile Epilepsy Education Package is already approved in Canada for the following indications:

Approved in Canada as MEEP for:

• Epilepsy education and management

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

The Scientific and Technological Research Council of Turkey

Collaborator

Trials

197

Recruited

24,700+

Published Research Related to This Trial

A review of 149 mobile apps related to epilepsy found that only 20 met the criteria for effective self-management support, indicating a limited but available resource for patients.

Most apps focused on treatment tracking and seizure management, but many lacked diverse self-management features and behavioral change techniques, highlighting the need for more comprehensive app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mobile apps for epilepsy self-management. Escoffery, C., McGee, R., Bidwell, J., et al.[2019]

The Mobile Epilepsy Education Package (MEEP) significantly improved mothers' knowledge about epilepsy and reduced their anxiety regarding seizures, as shown in a study with 60 mothers of children aged 3-6 with epilepsy.

The study demonstrated that MEEP is a practical, low-cost mobile application that effectively enhances understanding and management of epilepsy for caregivers, making it a valuable tool in pediatric neurology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study: Evaluating the efficacy of a mobile application developed for mothers who have children with epilepsy in Turkiye. Sayik, D., Acikgoz, A., Yimenicioglu, S.[2023]

The ENN project developed an interactive multimedia tutorial on epilepsy aimed at educating healthcare professionals, particularly General Practitioners, to improve diagnosis and treatment, thereby reducing unnecessary consultations and medication.

The tutorial, which includes 1300 pages of content, videos, and interactive features, has been distributed to over 100 general physicians in Germany, Portugal, and France, with plans for regular updates to keep the information current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The epilepsy tutorial. Binnie, C., Spreng, M.[2004]

A new website (www.pennsw.com.au) was developed to provide essential information and resources for general paediatricians and families managing children with epilepsy, enhancing communication between different levels of care.

In a survey of 49 paediatricians and 32 caregivers, the majority found the website to be well-designed and clinically useful, with high engagement reflected in 120,000 page views within the first year of launch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for children and adolescents with epilepsy: creating an innovative electronic educational resource. Connolly, AM., Slade, R., Uppal, P., et al.[2015]

Digital and mobile platforms for epilepsy self-management offer constant accessibility, making it easier for patients to manage their condition anytime and anywhere.

These platforms are rapidly scalable and cost-effective compared to traditional in-person programs, potentially increasing access to care for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management in Epilepsy Care: Untapped Opportunities. Ozuna, J., Kelly, P., Towne, A., et al.[2020]

A study involving 130 participants (people with epilepsy and their caregivers) found that adding a virtual interactive education session significantly improved epilepsy knowledge scores compared to just providing digital educational materials.

Both groups showed improved knowledge after the education, but the intervention group had notably higher scores, while there was no difference in quality of life or seizure frequency between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an additional virtual interactive session increase the impact of digital educational material given to epilepsy patients? A randomized controlled trial. Sepat, R., Sinha, AP., Murry, LL., et al.[2022]

The EpApp mobile application significantly improved epilepsy knowledge among adolescents, with both self and general knowledge increasing after using the app (p ≤ 0.005).

Participants required fewer medication reminders during and after the intervention, indicating improved medication adherence (from an average of 6.64 reminders at baseline to 2.93 during the intervention, p = 0.002).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EpApp: Development and evaluation of a smartphone/tablet app for adolescents with epilepsy. Le Marne, FA., Butler, S., Beavis, E., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36870141/

Evaluating the efficacy of a mobile application developed ... A randomized controlled study: Evaluating the efficacy of a mobile application developed for mothers who have children with epilepsy in Turkiye.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505025003014

Evaluating the efficacy of a mobile epilepsy education ... The MEEP mobile application is effective in increasing parents' knowledge of epilepsy. The MEEP mobile application is effective in reducing parents' anxiety ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40561847/

Evaluating the efficacy of a mobile epilepsy education ... MEEP training, adapted for Canadian context, resulted in increased knowledge and decreased anxiety. This simple-to-use, easy-to-access, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04343352

Study Details | NCT04343352 | Evaluation of the Efficiency ... The aim of the research is to develop and evaluate the effectiveness of the mobile epilepsy education program for parents with children diagnosed with epilepsy.

5. clinicaltrial.be clinicaltrial.be/en/details/435566?per_page=100&only_recruiting=0&only_eligible=0

Evaluating the Efficacy of a Mobile Epilepsy Education Ap... To determine whether the MEEP used by parents/caregivers with children diagnosed with epilepsy increases the level of knowledge about epilepsy.

6. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(25)00301-4/abstract

Evaluating the efficacy of a mobile epilepsy education ... Epilepsy education given to caregivers can positively support a child diagnosed with epilepsy and their family. A Mobile Epilepsy Education Package (MEEP) ...