NCT04023851

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

July 15, 2019

Last Update Submit

October 26, 2020

Conditions

Epilepsy

Keywords

EpilepsySeizure diaryMobile application

Outcome Measures

Primary Outcomes (1)

  • 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. 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.

    2 months

Secondary Outcomes (1)

  • AED compliance

    2 months

Study Arms (2)

Adolescent patient

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

Device: Mobile application Brain4U

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

Interventions

Mobile application Brain4UDEVICE

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

Adolescent patientParents with epilepsy children

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hunmin Kim, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 18, 2019

Study Start

April 12, 2019

Primary Completion

December 31, 2019

Study Completion

July 15, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

KR(1)