Remote Tracking of Epilepsy Patients

Withdrawn

• Conditions: Epilepsy
• Interventions: Device: HealthBuddy

• Registration Number: NCT01130649
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Study Start: 2010-07
• Primary Completion: 2011-07
• Study Completion: 2013-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
• Recent problem with substance abuse.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy patients, electronic diary	HealthBuddy	Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance

Primary Outcome Measures

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

Trial Locations

Locations (1)

Univ of California San Fran; 🇺🇸 San Francisco, California, United States