Remote Tracking of Epilepsy Patients

This study has been withdrawn prior to enrollment.
(not funded)
Sponsor:
Collaborator:
San Francisco Veterans Administration Medical Center
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01130649
First received: May 24, 2010
Last updated: April 2, 2012
Last verified: April 2012

May 24, 2010
April 2, 2012
July 2010
July 2011   (final data collection date for primary outcome measure)
  • Seizure frequency per month [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment of seizure count accuracy by assessing total number of seizures reported per month
  • Medication compliance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assessment of compliance with taking medications at regularly scheduled intervals
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures
Same as current
Complete list of historical versions of study NCT01130649 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Not Provided
Not Provided
Not Provided
Probability Sample

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.

Epilepsy
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.
  • Epilepsy patients, electronic diary
    Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance
    Intervention: Device: HealthBuddy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2013
July 2011   (final data collection date for primary outcome measure)

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.
Both
6 Months to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01130649
Epitrack
No
John D Hixson, UCSF
University of California, San Francisco
San Francisco Veterans Administration Medical Center
Principal Investigator: John Hixson, MD University of California, San Francisco
University of California, San Francisco
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP