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Completed

NCT Number: NCT04023851

Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile application Brain4U

Device

Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.

Primary outcomes

  1. Evaluation of knowledge acquisition in epilepsy

    Time frame: 2 months

    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.

Secondary outcomes

  1. AED compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 18, 2019
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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