Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

Completed

• Conditions: Epilepsy
• Interventions: Device: Mobile application Brain4U

• Registration Number: NCT04023851
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.

Detailed Description

Investigators assess the general and personal knowledge of epilepsy, compliance of antiepileptic drugs (AED), and self efficacy scale. Participants be asked to use the mobile application (Brain4U) and record seizure type, frequency of seizures, aggravating factors, and adverse events related to antiepileptic drugs for 2 month period.

Study Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-18
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Participants must be between the ages of 1-99.
• Participants must attend Seoul National University Bundang Hospital Pediatric Neurology Outpatient Clinic.
• Participants under age 18 must have an adult guardian give informed consent.
• Participants must have a functioning smartphone (iOS or Android) which can download the and perform Brain4U application.
• Participants must be able to use mobile application skillfully.

Exclusion Criteria

• Person who does not have smartphone nor restricted to use mobile application can not participate this study.
• Person with intellectual disability or unable to use mobile application can not participate this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parents with epilepsy children	Mobile application Brain4U	* Participants who have child with epilepsy (ages of 1-15) * Participants' child who are taking antiepileptic drug for seizure control
Adolescent patient	Mobile application Brain4U	* Participant between the ages of 15-18 * Participants who are taking antiepileptic drug for seizure control

Primary Outcome Measures

Name	Time	Method
Evaluation of knowledge acquisition in epilepsy	2 months	Baseline and 2 month Timepoint scores from questionnaires are assessed. Improvement in knowledge acquisition and self-efficacy by using questionnaire.; 1. Genetal knowledge (G) Questionnaire: There are total 10 questions (1 point score for each question) to evaluate general knowlege about epilepsy.; Score reported as (mean, SD), higher scores are better. Score ranges 0 to 10.; 2. Persional knowledge (P) questionnaire: There are total 4 questions (1 point score for each question) to evaluate knowlege about individual's epilepsy.; Score reported as (mean, SD), higher scores are better. Score ranges 0 to 4.; 3. Self-efficacy scale (SE): There are 4 questions (1 point score for each question) to evaluate self-efficacy scale.; Score reported as (mean, SD), higher scores are better. Score ranges 0 to 4.

Secondary Outcome Measures

Name	Time	Method
AED compliance	2 months	Baseline and 2 month Timepoint AED compliances are reported.; Assess improvement of AED compliance by comparing "Days with AED per month" before and after using mobile application.; Count the "Days with AED" in a month and converted to the percentage.; Percentage ranges 0 to 100%. The high percentage means good compliance which means less AED skipping in a month.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of