EpilepsyNCT05418257
A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy
An observational study of Epilepsy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is an observational study to confirm the non-inferior effectiveness on health outcomes of tele-counseling or tele-prescription, which was the first outpatient system applied to the actual medical sites in Korea during the coronavirus disease 2019 (COVID-19) pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- (exposure) telemedicine
- How many people
- 307 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 May 2022to 31 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will conduct surveys and observation to evaluate the non-inferior-effectiveness of a telehealth between patients and guardians at the Samsung Medical Center's pediatric hospitalist service.
Who may be able to join
- Those who have received outpatient treatment for epilepsy at least twice from the Department of Neurology, Department of Pediatrics, Samsung Medical Center as of the date of participation in the study
- Those who have been taking one or more anticonvulsants for 3 months or more as of the date of participation in the study
- Those who have passed more than one month from the date of discharge from the hospital as of the date of participation in the study (However, hospitalization for examination only does not fall under this standard)
Who cannot join
- Those who have an experience of inpatient treatment within 1 month as of the date of participation in the study (However, hospitalization for examination only is not classified as hospitalization under this standard)
- Those who have a record of visiting the emergency room within 1 month as of the date of participation in the study (However, visits that are not for epilepsy drug control are not classified as emergency room visits according to this standard)
- Those who have been diagnosed with psychogenic non-epileptic seizure (PNES) through electroencephalogram (EEG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Non-face-to-face Care Using the Phone, Such as Counseling and Prescription, Temporarily Permitted During the COVID-19 Pandemic
This is an observational study to confirm the non-inferior effectiveness on health outcomes of tele-counseling or tele-prescription, which was the first outpatient system applied to the actual medical sites in Korea during the coronavirus disease 2019 (COVID-19) pandemic. Researchers collect data using electronic medical records and questionnaires to patients and their caregivers who are continuously receiving outpatient treatment for epilepsy at a single center. The results of the study will be presented by comparing the health outcomes between the non-face-to-face care group and the usual care group.
Read the detailed description
During the COVID-19 pandemic, temporary phone consultations or prescriptions are being conducted at actual medical sites in Korea. Now, interest about non-face-to-face medical care and expectation that this medical service will be available in the post COVID-19 era are increasing.
The aim to study non-inferior effectiveness of health outcomes for epilepsy by comparing non-face-to-face care with usual care. In this observational study, two groups are recruited in a matched pair parallel in 1:2 allocation at single outpatient clinic. And then investigators collect data such as seizure control, adherence to treatment, adverse drugs reactions by using electronic medical records and questionnaires.
Because epilepsy, the target disease of the study, has chronic and recurrent symptoms, it is necessary for patients to visit the hospital regularly to check their condition. However, there are few neurologists in the province who can treat epilepsy. So that Patients and their caregivers spend a lot of time and money traveling long distances to get treatment.
- Conditions
- Epilepsy
- Being tested
- (exposure) telemedicine
- Keywords
- Telemedicine, Telehealth, Non-face-to-face
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(exposure) telemedicineOther
medical counseling or treatment only using phone
| Study group | Role | What they receive |
|---|---|---|
| Usual-Outpatients with Epilepsy | Patient who received treatment at Samsung Medical Center more than twice for epilepsy | |
| Tele-Outpatients with Epilepsy | Patient who received telemedicine at the time of recruitment and treatment at Samsung Medical Center more than twice for epilepsy Receives: Other: (exposure) telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure control - 1) Change from baseline seizure frequency at 6 months
It will be assessed by semi-structured questionnaire and EMR review about categorizing seizure frequency.
: several times per day, 1~2 times per day, several times per week, 1~2 times per week, several times per month, 1~2 times per month, several times per year
Measured: both at the beginning of the study (month 0) and at the end of the study (month 6)
Seizure control - 2) Change from baseline seizure type at 6 months
It will be collected by participants' free text description and EMR review and then will be categorized to generalized, tonic, atonic, focal, absence and status epilepticus by physicians.
Successful seizure control is defined as no step up in category of seizure frequency and no manifestation of new-onset generalized, tonic/atonic seizure with fall or status epilepticus during study period.
Measured: both at the beginning of the study (month 0) and at the end of the study (month 6)
Secondary outcomes (3)
adherence to treatment - 1) Medication compliance
Medication compliance will be collected by self-report using Likert scale from 1 (worst) to 5 (best compliance as possible)
Measured: at the end of the study (month 6)
adherence to treatment - 2) Outpatient visit compliance
Outpatient visit compliance will be assessed by counting complete in-person visit or telephone consultation and no-shows.
Measured: at the end of the study (month 6)
Change from baseline adverse drugs reactions at 6 months
comparing change and new development of adverse drugs reactions between telemedicine group and usual care group
Measured: both at the beginning of the study (month 0) and at the end of the study (month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start16 May 2022
- Primary completion1 May 2023
- Study completion31 May 2023
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 Samsung Medical CenterThe 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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Seuk, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418257
- Sponsor's protocol ID
- 2022-04-059-001
- Status last verified
- Aug 2023
- First submitted
- 17 May 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Non-face-to-face Care Using the Phone, Such as Counseling and Prescription, Temporarily Permitted During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05418257
- Acronym / sponsor ID
- 2022-04-059-001
- Conditions
- Epilepsy
- Keywords
- Telemedicine, Telehealth, Non-face-to-face
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 14 Jun 2022 (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.
This is an observational study to confirm the non-inferior effectiveness on health outcomes of tele-counseling or tele-prescription, which was the first outpatient system applied to the actual medical sites in Korea during the coronavirus disease 2019 (COVID-19) pandemic. Researchers collect data using electronic medical records and questionnaires to patients and their caregivers who are continuously receiving outpatient treatment for epilepsy at a single center. The results of the study will be presented by comparing the health outcomes between the non-face-to-face care group and the usual care group.
Detailed description
During the COVID-19 pandemic, temporary phone consultations or prescriptions are being conducted at actual medical sites in Korea. Now, interest about non-face-to-face medical care and expectation that this medical service will be available in the post COVID-19 era are increasing.
The aim to study non-inferior effectiveness of health outcomes for epilepsy by comparing non-face-to-face care with usual care. In this observational study, two groups are recruited in a matched pair parallel in 1:2 allocation at single outpatient clinic. And then investigators collect data such as seizure control, adherence to treatment, adverse drugs reactions by using electronic medical records and questionnaires.
Because epilepsy, the target disease of the study, has chronic and recurrent symptoms, it is necessary for patients to visit the hospital regularly to check their condition. However, there are few neurologists in the province who can treat epilepsy. So that Patients and their caregivers spend a lot of time and money traveling long distances to get treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual-Outpatients with Epilepsy | – | –Patient who received treatment at Samsung Medical Center more than twice for epilepsy |
| Tele-Outpatients with Epilepsy | – | Other: (exposure) telemedicinePatient who received telemedicine at the time of recruitment and treatment at Samsung Medical Center more than twice for epilepsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will conduct surveys and observation to evaluate the non-inferior-effectiveness of a telehealth between patients and guardians at the Samsung Medical Center's pediatric hospitalist service.
Key inclusion criteria (3 listed)
- Those who have received outpatient treatment for epilepsy at least twice from the Department of Neurology, Department of Pediatrics, Samsung Medical Center as of the date of participation in the study
- Those who have been taking one or more anticonvulsants for 3 months or more as of the date of participation in the study
- Those who have passed more than one month from the date of discharge from the hospital as of the date of participation in the study (However, hospitalization for examination only does not fall under this standard)
Key exclusion criteria (3 listed)
- Those who have an experience of inpatient treatment within 1 month as of the date of participation in the study (However, hospitalization for examination only is not classified as hospitalization under this standard)
- Those who have a record of visiting the emergency room within 1 month as of the date of participation in the study (However, visits that are not for epilepsy drug control are not classified as emergency room visits according to this standard)
- Those who have been diagnosed with psychogenic non-epileptic seizure (PNES) through electroencephalogram (EEG)
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 |
|---|---|---|
| (exposure) telemedicinemedical counseling or treatment only using phone | Other | Tele-Outpatients with Epilepsy |
Primary outcome
Seizure control - 1) Change from baseline seizure frequency at 6 months
Time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)
It will be assessed by semi-structured questionnaire and EMR review about categorizing seizure frequency. : several times per day, 1~2 times per day, several times per week, 1~2 times per week, several times per month, 1~2 times per month, several times per year
Seizure control - 2) Change from baseline seizure type at 6 months
Time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)
It will be collected by participants' free text description and EMR review and then will be categorized to generalized, tonic, atonic, focal, absence and status epilepticus by physicians. Successful seizure control is defined as no step up in category of seizure frequency and no manifestation of new-onset generalized, tonic/atonic seizure with fall or status epilepticus during study period.
3 secondary outcomes
adherence to treatment - 1) Medication compliance
Time frame: at the end of the study (month 6)
adherence to treatment - 2) Outpatient visit compliance
Time frame: at the end of the study (month 6)
Change from baseline adverse drugs reactions at 6 months
Time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)
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 22 Aug 2024.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Lee Seuk, M.D. principal investigator
Samsung Medical Center
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 Samsung Medical Center 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 3 inclusion and 3 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 22 Aug 2024. 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?
Seizure control - 1) Change from baseline seizure frequency at 6 months (time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)). The study lists 2 primary outcomes in all. 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 22 Aug 2024.