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Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

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ClinicalTrials.gov Identifier: NCT04023851
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hunmin Kim, 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.

Condition or disease Intervention/treatment
Epilepsy 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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.




Primary Outcome Measures :
  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.

    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 :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023851


Contacts
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Contact: Hunmin Kim, MD, PhD 82-31-787-7297 hunminkim@snubh.org

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Hyunyoung Baek, Nurse       bhy210@snubh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hunmin Kim, MD, PhD Seoul National University Bundang Hospital

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Responsible Party: Hunmin Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04023851     History of Changes
Other Study ID Numbers: 01
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hunmin Kim, Seoul National University Hospital:
Epilepsy
Seizure diary
Mobile application
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants