Remote Tracking of Epilepsy Patients

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01130649
• Other study ID #: Epitrack
• Status: Withdrawn
• Phase: N/A
• First received: May 24, 2010
• Last updated: May 1, 2017
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Univ of California San Fran	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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