Remote Tracking of Epilepsy Patients

Study Overview
=================
Brief Summary
-----------------
The investigators propose a novel method for tracking the seizure frequency, side effect burden, and medication compliance for patients with epilepsy. The investigators intend to utilize a table-top device currently for tracking other chronic disease to collect remote data from epilepsy patients. The hypothesis is that the use of this device will lead to better longterm treatment outcomes than the standard outpatient mechanism of following patients longitudinally.

Official Title
-----------------
Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: HealthBuddy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded. Patient can range in age from birth to 65 years old; in cases of child participants, the parents are responsible for data reporting. Patients must have a seizure frequency of at least two seizures in a 6 month period of time. Patients must be on at least one anti-epileptic medication. Patients and/or legal guardian must be able to report seizure frequency with either a paper or electronic diary. Patients and/or legal guardians must be able to read and understand either English or Spanish. Patients and/or legal guardians must be able to complete questionnaires and provide informed consent to this study. Exclusion Criteria: Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis Recent problem with substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epilepsy patients, electronic diary<br>Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance | Device: HealthBuddy<br>* Noninvasive device for remotely reporting health information. The device does nothing to change the health of the patient, but transmits health data that is entered by the patient directly to the physician's office. Patients will enter data on seizure frequency, medication compliance, and side effects.<br>* Other names: Healthbuddy is a product of Bosch Healthcare, and is already utilized in many medical institutions around the country, including the VA Health System.;|
| Epilpesy patient, no electronic diary<br>Group of epilepsy patients who are followed using the standard of care, which is a paper diary and routine outpatient follow up visits | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency per month | Assessment of seizure count accuracy by assessing total number of seizures reported per month | 1 year | 
| Medication compliance | Assessment of compliance with taking medications at regularly scheduled intervals | 1 year | 
| Quality of life | Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Tracking, Electronic diary