EpilepsyNCT04023851
Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care
An observational study of Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Mobile application Brain4U
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Apr 2019to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care
The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Mobile application Brain4U
- Keywords
- Epilepsy, Seizure diary, Mobile application
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent patient | * Participant between the ages of 15-18
* Participants who are taking antiepileptic drug for seizure control Receives: 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 Receives: Device: Mobile application Brain4U |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start12 Apr 2019
- Primary completion31 Dec 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hunmin Kim, Seoul National University Hospital
- Investigators
- Hunmin Kim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023851
- Sponsor's protocol ID
- 01
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care
- ClinicalTrials.gov ID
- NCT04023851
- Acronym / sponsor ID
- 01
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizure diary, Mobile application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent patient | – | Device: Mobile application Brain4U* Participant between the ages of 15-18 * Participants who are taking antiepileptic drug for seizure control |
| Parents with epilepsy children | – | Device: Mobile application Brain4U* Participants who have child with epilepsy (ages of 1-15) * Participants' child who are taking antiepileptic drug for seizure control |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application Brain4UBrain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs. | Device | Adolescent patient, Parents with epilepsy children |
Primary outcome
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.
1 secondary outcome
AED compliance
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hunmin Kim, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of knowledge acquisition in epilepsy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.