Evaluating the Efficacy of a Mobile Epilepsy Education Application

NCT06402526 | Completed DMC

• 1 other identifier: MEA-EE (2024-10228)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Epilepsy; Epilepsy in Children; Anxiety; Knowledge, Attitudes, Practice

Keywords

Epilepsy; Mobile application; Education; Anxiety; Knowledge; Parents/Caregivers

Outcome Measures

Primary Outcomes (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.

  7 weeks

Secondary Outcomes (1)

• Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education

  7 weeks

Study Arms (2)

Mobile Epilepsy Education Package

EXPERIMENTAL

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

Standard care consisting of epilepsy education

OTHER

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

Interventions

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.

Mobile Epilepsy Education Package

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.

Standard care consisting of epilepsy education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Inability to provide informed consent for any reason.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (10)

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  PMID: 9689606 RESULT

• 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.

  RESULT

• 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.

  PMID: 33053164 RESULT

• 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.

  PMID: 28199920 RESULT

• 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.

  PMID: 26029490 RESULT

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  PMID: 29494935 RESULT

• 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.

  PMID: 36870141 RESULT

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  PMID: 17126082 RESULT

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  PMID: 29203274 RESULT

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Study Officials

• Kenneth Alexis Myers, MD PhD FRCPC

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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible participants will be randomly allocated in a 1:1 ratio to the intervention group (use of MEEP) or the control group (standard care).

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 7, 2024
• Study Start: June 10, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 7, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It is completed December 2024.
• Access Criteria: The study protocol will be published in a journal. ICF can be requested from the author.

Locations

CA (2)