Remote Tracking of Epilepsy Patients

NCT ID: NCT01130649

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Epilepsy patients, electronic diary

Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance

HealthBuddy

Intervention Type DEVICE

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.

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Healthbuddy is a product of Bosch Healthcare, and is already utilized in many medical institutions around the country, including the VA Health System.

Eligibility Criteria

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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

* Recent problem with substance abuse.
Minimum Eligible Age

6 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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John Hixson

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Hixson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Univ of California San Fran

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Epitrack

Identifier Type: -

Identifier Source: org_study_id

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