A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy

Completed

• Conditions: Epilepsy
• Interventions: Other: (exposure) telemedicine

• Registration Number: NCT05418257
• Lead Sponsor: Samsung Medical Center

Brief 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. 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 Timeline

• Study Start: 2022-05-16
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Seizure control - 2) Change from baseline seizure type at 6 months	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.
Seizure control - 1) Change from baseline seizure frequency at 6 months	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

Secondary Outcome Measures

Name	Time	Method
adherence to treatment - 2) Outpatient visit compliance	at the end of the study (month 6)	Outpatient visit compliance will be assessed by counting complete in-person visit or telephone consultation and no-shows.
adherence to treatment - 1) Medication compliance	at the end of the study (month 6)	Medication compliance will be collected by self-report using Likert scale from 1 (worst) to 5 (best compliance as possible)
Change from baseline adverse drugs reactions at 6 months	both at the beginning of the study (month 0) and at the end of the study (month 6)	comparing change and new development of adverse drugs reactions between telemedicine group and usual care group

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-go, Korea, Republic of