Clinical trial NCT05418257: A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Telemedicine
Telehealth
Non-face-to-face
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 307
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Seizure control - 1) Change from baseline seizure frequency at 6 months
timeFrame: both at the beginning of the study (month 0) and at the end of the study (month 6)
measure: Seizure control - 2) Change from baseline seizure type at 6 months
timeFrame: both at the beginning of the study (month 0) and at the end of the study (month 6)
Secondary outcomes:
measure: adherence to treatment - 1) Medication compliance
timeFrame: at the end of the study (month 6)
measure: adherence to treatment - 2) Outpatient visit compliance
timeFrame: at the end of the study (month 6)
measure: Change from baseline adverse drugs reactions at 6 months
timeFrame: both at the beginning of the study (month 0) and at the end of the study (month 6)
Other outcomes:
measure: patient reported experience - 1) Reasons for using current care system (in-person versus telemedicine)
timeFrame: both at the beginning of the study (month 0) and at the end of the study (month 6)
measure: patient reported experience - 2) Estimated time for outpatient visit
timeFrame: at the end of the study (month 6)
measure: patient reported experience - 3) Estimated cost for outpatient visit
timeFrame: at the end of the study (month 6)
measure: patient reported experience - 4) Participants satisfaction
timeFrame: at the end of the study (month 6)
measure: patient reported experience - 5) Caregiver satisfaction
timeFrame: at the end of the study (month 6)
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-go
Study officials:
affiliation: Samsung Medical Center
name: Lee Seuk, M.D.
role: PRINCIPAL_INVESTIGATOR
References: