Evaluating the Efficacy of a Mobile Epilepsy Education Application
NCT ID: NCT06402526
Last Updated: 2025-10-07
Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2024-06-10
2024-12-30
Brief Summary
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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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Detailed Description
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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:
1. "treatment/exam control time reminder" tab in the "follow-up section" of MEEP; and
2. 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mobile Epilepsy Education Package
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
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
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.
Standard care consisting of epilepsy education
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.
Interventions
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Mobile Epilepsy Education Package
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Kenneth Myers, MD
Principal Investigator
Principal Investigators
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Kenneth Alexis Myers, MD PhD FRCPC
Role: PRINCIPAL_INVESTIGATOR
RI-MUHC, Montreal Children's Hospital, McGill University
Dilek Sayik, RN, PhD
Role: STUDY_CHAIR
Ingram School of Nursing, McGill University
Ayfer Acikgoz, RN, PhD
Role: STUDY_CHAIR
Faculty of Health Sciences, Eskisehir Osmangazi University
Argerie Tsimicalis, RN, PhD
Role: STUDY_CHAIR
Shriners Hospitals for Children, Ingram School of Nursing, McGill University
Locations
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Montreal Children's Hospital
Montreal, Quebec, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MEA-EE (2024-10228)
Identifier Type: -
Identifier Source: org_study_id
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