A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418257
• Other study ID #: 2022-04-059-001
• Status: Completed
• Start date: May 16, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• (exposure) telemedicine
medical counseling or treatment only using phone

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-go

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	patient reported experience - 2) Estimated time for outpatient visit	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)
Other	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)
Other	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)
Other	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)
Primary	Seizure control - 1) Change from baseline seizure frequency at 6 months	It will be assessed by semi-structured questionnaire 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)
Primary	Seizure control - 2) Change from baseline seizure type at 6 months	It will be collected by participants' free text description 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	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)
Secondary	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.	at the end of the study (month 6)
Secondary	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)