A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy

NCT05418257 | Completed

• 1 other identifier: 2022-04-059-001
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Telemedicine; Telehealth; Non-face-to-face

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  at the end of the study (month 6)

• adherence to treatment - 2) Outpatient visit compliance

  at the end of the study (month 6)

• 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)

Other Outcomes (5)

• patient reported experience - 1) Reasons for using current care system (in-person versus telemedicine)

  both at the beginning of the study (month 0) and at the end of the study (month 6)

• patient reported experience - 2) Estimated time for outpatient visit

  at the end of the study (month 6)

• patient reported experience - 3) Estimated cost for outpatient visit

  at the end of the study (month 6)

Study Arms (2)

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

Other: (exposure) telemedicine

Interventions

(exposure) telemedicine OTHER

medical counseling or treatment only using phone

Tele-Outpatients with Epilepsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-go, 06351, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lee Seuk, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 14, 2022
• Study Start: May 16, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 31, 2023
• Last Updated: August 22, 2024

Record last verified: 2023-08

Locations

KR (1)