Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: Mobile application Brain4U

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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are 2 groups of study population in this study:

Adolescent patients with epilepsy and Parents with epilepsy children.

1. Adolescent patient

   • Participant between the ages of 15-18
   • Participants who are taking antiepileptic drug for seizure control

2. Parents with epilepsy children

   • Participants who have child with epilepsy (ages of 1-15)
   • Participants' child who are taking antiepileptic drug for seizure control

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescent patient; Participant between the ages of 15-18; Participants who are taking antiepileptic drug for seizure control	Device: Mobile application Brain4U; Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.
Parents with epilepsy children; Participants who have child with epilepsy (ages of 1-15); Participants' child who are taking antiepileptic drug for seizure control	Device: Mobile application Brain4U; Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of knowledge acquisition in epilepsy	Baseline and 2 month Timepoint scores from questionnaires are assessed. Improvement in knowledge acquisition and self-efficacy by using questionnaire.; 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.; 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.; 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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AED compliance	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.	2 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hunmin Kim, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Epilepsy; Mobile application; Seizure diary
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No