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A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy

Samsung Medical Center logo

Samsung Medical Center

Status

Completed

Conditions

Epilepsy

Treatments

Other: (exposure) telemedicine

Study type

Observational

Funder types

Other

Identifiers

NCT05418257
2022-04-059-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

307 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 design

307 participants in 2 patient groups

Usual-Outpatients with Epilepsy
Description:
Patient who received treatment at Samsung Medical Center more than twice for epilepsy
Tele-Outpatients with Epilepsy
Description:
Patient who received telemedicine at the time of recruitment and treatment at Samsung Medical Center more than twice for epilepsy
Treatment:
Other: (exposure) telemedicine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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