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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Epilepsy
Device: HealthBuddy

Study Type: Observational
Official Title: Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130649

Locations
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 Administration Medical Center
Investigators
Principal Investigator: John Hixson, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: John D Hixson, UCSF
ClinicalTrials.gov Identifier: NCT01130649     History of Changes
Other Study ID Numbers: Epitrack
Study First Received: May 24, 2010
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Epilepsy
Tracking
Electronic diary

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014