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Remote Tracking of Epilepsy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01130649
Recruitment Status : Withdrawn (not funded)
First Posted : May 26, 2010
Last Update Posted : May 3, 2017
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
John Hixson, 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.

Condition or disease Intervention/treatment
Epilepsy Device: HealthBuddy

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Other
Official Title: Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy
Study Start Date : July 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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 Name: 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

Primary Outcome Measures :
  1. Seizure frequency per month [ Time Frame: 1 year ]
    Assessment of seizure count accuracy by assessing total number of seizures reported per month

  2. Medication compliance [ Time Frame: 1 year ]
    Assessment of compliance with taking medications at regularly scheduled intervals

  3. Quality of life [ Time Frame: 1 year ]
    Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01130649

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United States, California
Univ of California San Fran
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
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Principal Investigator: John Hixson, MD University of California, San Francisco

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Responsible Party: John Hixson, Associate Professor of Neurology, University of California, San Francisco Identifier: NCT01130649     History of Changes
Other Study ID Numbers: Epitrack
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by John Hixson, University of California, San Francisco:
Electronic diary
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases