Anxiety, Epilepsy, Epilepsy in Children, Knowledge, Attitudes, Practice
Conditions
Keywords
Epilepsy, Mobile application, Education, Anxiety, Knowledge, Parents/Caregivers
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.
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: 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).
Interventions
OTHERMobile 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.
OTHERStandard 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.
Sponsors
The Scientific and Technological Research Council of Turkey
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
\- Inability to provide informed consent for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package | 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education | 7 weeks | 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. |
Countries
Canada
Outcome results
None listed