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EpilepsyNCT06402526

Evaluating the Efficacy of a Mobile Epilepsy Education Application

A study testing Mobile Epilepsy Education Package in people with Epilepsy and Epilepsy in Children, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy, Epilepsy in Children, Anxiety
What is being tested?
Mobile Epilepsy Education Package
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesCanada
Study dates
10 Jun 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Inability to provide informed consent for any reason.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Montreal Children's Hospital

    Montreal, Quebec, H4A 3J1

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official 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

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.

Read the 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:
  3. "treatment/exam control time reminder" tab in the "follow-up section" of MEEP; and
  4. 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).
Being tested
Mobile Epilepsy Education Package, Standard care consisting of epilepsy education
Keywords
Epilepsy, Mobile application, Education, Anxiety, Knowledge, Parents/Caregivers
Medical subject headings
Epilepsy, Anxiety Disorders, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Epilepsy Education PackageOther

    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 educationOther

    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.

Study groups in NCT06402526
Study groupRoleWhat they receive
Mobile Epilepsy Education PackageExperimentalThe 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.
Receives: Other: Mobile Epilepsy Education Package
Standard care consisting of epilepsy educationOtherStandard 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.
Receives: Other: Standard care consisting of epilepsy education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package

    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.

    Measured: 7 weeks

Secondary outcomes (1)
  1. Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education

    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.

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start10 Jun 2024
  3. Primary completion30 Aug 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomly allocated in a 1:1 ratio to the intervention group (use of MEEP) or the control group (standard care).
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402526
Sponsor's protocol ID
MEA-EE (2024-10228)
Status last verified
Jun 2024
First submitted
29 Apr 2024
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Share study protocol, materials (eg consent form, recruitment flyers). App will be available in the future for free download.

Publications

  • Aaberg KM, Gunnes N, Bakken IJ, Lund Soraas C, Berntsen A, Magnus P, Lossius MI, Stoltenberg C, Chin R, Suren P. Incidence and Prevalence of Childhood Epilepsy: A Nationwide Cohort Study. Pediatrics. 2017 May;139(5):e20163908. doi: 10.1542/peds.2016-3908. Epub 2017 Apr 5.

    PubMed 28557750
  • Austin J, Dunn D, Huster G, Rose D. Development of scales to measure psychosocial care needs of children with seizures and their parents. 1. J Neurosci Nurs. 1998 Jun;30(3):155-60. doi: 10.1097/01376517-199806000-00002.

    PubMed 9689606
  • Austin JK, McNelis AM, Shore CP, Dunn DW, Musick B. A feasibility study of a family seizure management program: 'Be Seizure Smart. Journal of Neuroscience Nursing. 2002; 34(1): 30.

  • Bakula DM, Wetter SE, Peugh JL, Modi AC. A Longitudinal Assessment of Parenting Stress in Parents of Children with New-Onset Epilepsy. J Pediatr Psychol. 2021 Jan 20;46(1):91-99. doi: 10.1093/jpepsy/jsaa091.

    PubMed 33053164
  • Carlson JM, Miller PA. Family burden, child disability, and the adjustment of mothers caring for children with epilepsy: Role of social support and coping. Epilepsy Behav. 2017 Mar;68:168-173. doi: 10.1016/j.yebeh.2017.01.013. Epub 2017 Feb 12.

    PubMed 28199920
  • Dennis TA, O'Toole L. Mental Health on the Go: Effects of a Gamified Attention Bias Modification Mobile Application in Trait Anxious Adults. Clin Psychol Sci. 2014 Sep 1;2(5):576-590. doi: 10.1177/2167702614522228.

    PubMed 26029490
  • Escoffery C, McGee R, Bidwell J, Sims C, Thropp EK, Frazier C, Mynatt ED. A review of mobile apps for epilepsy self-management. Epilepsy Behav. 2018 Apr;81:62-69. doi: 10.1016/j.yebeh.2017.12.010. Epub 2018 Mar 20.

    PubMed 29494935
  • Sayik D, Acikgoz A, Yimenicioglu S. A randomized controlled study: Evaluating the efficacy of a mobile application developed for mothers who have children with epilepsy in Turkiye. J Pediatr Nurs. 2023 May-Jun;70:103-110. doi: 10.1016/j.pedn.2023.02.010. Epub 2023 Mar 2.

    PubMed 36870141
  • Wohlrab GC, Rinnert S, Bettendorf U, Fischbach H, Heinen G, Klein P, Kluger G, Jacob K, Rahn D, Winter R, Pfafflin M; Famoses Project Group. famoses: a modular educational program for children with epilepsy and their parents. Epilepsy Behav. 2007 Feb;10(1):44-8. doi: 10.1016/j.yebeh.2006.10.005. Epub 2006 Nov 27.

    PubMed 17126082
  • Turan Gurhopur FD, Isler Dalgic A. The effect of a modular education program for children with epilepsy and their parents on disease management. Epilepsy Behav. 2018 Jan;78:210-218. doi: 10.1016/j.yebeh.2017.07.048. Epub 2017 Dec 6.

    PubMed 29203274

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Epilepsy Education Package in people with Epilepsy and Epilepsy in Children, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06402526, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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