Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023851
• Other study ID #: 01
• Status: Completed
• Start date: April 12, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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