Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (exposure) telemedicine | Other | medical counseling or treatment only using phone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at the end of the study (month 6) |
| adherence to treatment - 2) Outpatient visit compliance |
| Measure | Description | Time Frame |
|---|---|---|
| patient reported experience - 1) Reasons for using current care system (in-person versus telemedicine) | The reasons and obstacles for using current outpatient system will be collected with questionnaire. | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lee Seuk, M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam-go | 06351 | South Korea |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Outpatient visit compliance will be assessed by counting complete in-person visit or telephone consultation and no-shows. |
| 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 | both at the beginning of the study (month 0) and at the end of the study (month 6) |
The average round-trip time from patient's house to hospital will be collected by questionnaire and then estimated. |
| at the end of the study (month 6) |
| patient reported experience - 3) Estimated cost for outpatient visit | The opportunity cost will be collected by questionnaire and then estimated. | at the end of the study (month 6) |
| patient reported experience - 4) Participants satisfaction | The satisfaction and willingness of participant using opposite outpatient system (in-person vs telemedicine) will be assessed by questionnaires. | at the end of the study (month 6) |
| patient reported experience - 5) Caregiver satisfaction | The satisfaction and willingness of caregiver using opposite outpatient system (in-person vs telemedicine) will be assessed by questionnaires. | at the end of the study (month 6) |