Mobile Education App for Childhood Epilepsy

Recruiting at 1 trial location

Overseen By Dilek Sayik, PhD

Age: Any Age

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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mobile Epilepsy Education Package (MEEP)?

The study on the EpApp, a similar mobile application for adolescents with epilepsy, showed that it increased knowledge about epilepsy and reduced the need for medication reminders, indicating that mobile education apps can be effective in improving epilepsy management. ^{1 2 3 4 5}

Is the Mobile Education App for Childhood Epilepsy safe for use?

The available research on similar mobile apps for epilepsy, like EpApp, shows they are generally well-received and considered safe, with positive feedback on design and functionality. However, specific safety data for the Mobile Education App for Childhood Epilepsy is not detailed in the studies. ^{1 2 3 5 6}

How is the Mobile Epilepsy Education Package (MEEP) treatment different from other treatments for childhood epilepsy?

The Mobile Epilepsy Education Package (MEEP) is unique because it is a mobile app designed specifically to educate and support mothers of children with epilepsy, focusing on increasing knowledge and self-management skills, unlike traditional treatments that primarily involve medication. ^{1 2 4 5 7}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

EpApp: Development and evaluation of a smartphone/tablet app for adolescents with epilepsy. [2018]

2. United States 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. [2023]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Self-Management in Epilepsy Care: Untapped Opportunities. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A review of mobile apps for epilepsy self-management. [2019]

6. Scotland pubmed.ncbi.nlm.nih.gov

Caring for children and adolescents with epilepsy: creating an innovative electronic educational resource. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The epilepsy tutorial. [2004]