Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-22 @ 12:14 PM
Study NCT ID:
NCT04023851
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2019-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of knowledge acquisition in epilepsy', 'timeFrame': '2 months', 'description': "Baseline and 2 month Timepoint scores from questionnaires are assessed. Improvement in knowledge acquisition and self-efficacy by using questionnaire.\n\n1. Genetal knowledge (G) Questionnaire:\n\n There are total 10 questions (1 point score for each question) to evaluate general knowlege about epilepsy.\n\n Score reported as (mean, SD), higher scores are better. Score ranges 0 to 10.\n2. Persional knowledge (P) questionnaire:\n\n There are total 4 questions (1 point score for each question) to evaluate knowlege about individual's epilepsy.\n\n Score reported as (mean, SD), higher scores are better. Score ranges 0 to 4.\n3. Self-efficacy scale (SE): There are 4 questions (1 point score for each question) to evaluate self-efficacy scale.\n\nScore reported as (mean, SD), higher scores are better. Score ranges 0 to 4."}], 'secondaryOutcomes': [{'measure': 'AED compliance', 'timeFrame': '2 months', 'description': 'Baseline and 2 month Timepoint AED compliances are reported.\n\nAssess improvement of AED compliance by comparing "Days with AED per month" before and after using mobile application.\n\nCount the "Days with AED" in a month and converted to the percentage.\n\nPercentage ranges 0 to 100%. The high percentage means good compliance which means less AED skipping in a month.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Seizure diary', 'Mobile application'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "There are 2 groups of study population in this study:\n\nAdolescent patients with epilepsy and Parents with epilepsy children.\n\n1. Adolescent patient\n\n * Participant between the ages of 15-18\n * Participants who are taking antiepileptic drug for seizure control\n2. Parents with epilepsy children\n\n * Participants who have child with epilepsy (ages of 1-15)\n * Participants' child who are taking antiepileptic drug for seizure control", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be between the ages of 1-99.\n* Participants must attend Seoul National University Bundang Hospital Pediatric Neurology Outpatient Clinic.\n* Participants under age 18 must have an adult guardian give informed consent.\n* Participants must have a functioning smartphone (iOS or Android) which can download the and perform Brain4U application.\n* Participants must be able to use mobile application skillfully.\n\nExclusion Criteria:\n\n* Person who does not have smartphone nor restricted to use mobile application can not participate this study.\n* Person with intellectual disability or unable to use mobile application can not participate this study.'}, 'identificationModule': {'nctId': 'NCT04023851', 'briefTitle': 'Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescent patient', 'description': '* Participant between the ages of 15-18\n* Participants who are taking antiepileptic drug for seizure control', 'interventionNames': ['Device: Mobile application Brain4U']}, {'label': 'Parents with epilepsy children', 'description': "* Participants who have child with epilepsy (ages of 1-15)\n* Participants' child who are taking antiepileptic drug for seizure control", 'interventionNames': ['Device: Mobile application Brain4U']}], 'interventions': [{'name': 'Mobile application Brain4U', 'type': 'DEVICE', 'description': 'Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.', 'armGroupLabels': ['Adolescent patient', 'Parents with epilepsy children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Hunmin Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hunmin Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}