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.
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 Type
OBSERVATIONAL
Enrollment
307
medical counseling or treatment only using phone
Samsung Medical Center
Seoul, Gangnam-go, South Korea
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
Time frame: 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.
Time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)
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)
Time frame: 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.
Time frame: 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
Time frame: both at the beginning of the study (month 0) and at the end of the study (month 6)
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