Remote Tracking of Epilepsy Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy
• Intervention / Treatment: Device: HealthBuddy

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Univ of California San Fran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be recruited from the UCSF and VAMC Outpatient Epilepsy Centers. All study participants must have a confirmed diagnosis of epilepsy (defined by two or more unprovoked seizures) for at least 6 months.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy patients, electronic diary; Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance	Device: HealthBuddy; 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.; 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; 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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: John Hixson, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; Tracking; Electronic diary
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Epitrack