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Remote Tracking of Epilepsy Patients

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ClinicalTrials.gov Identifier: NCT01130649
Recruitment Status : Withdrawn (not funded)
First Posted : May 26, 2010
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
John Hixson, University of California, San Francisco

Tracking Information
First Submitted Date May 24, 2010
First Posted Date May 26, 2010
Last Update Posted Date May 3, 2017
Study Start Date July 2010
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2010)
  • Seizure frequency per month [ Time Frame: 1 year ]
    Assessment of seizure count accuracy by assessing total number of seizures reported per month
  • Medication compliance [ Time Frame: 1 year ]
    Assessment of compliance with taking medications at regularly scheduled intervals
  • Quality of life [ Time Frame: 1 year ]
    Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01130649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Remote Tracking of Epilepsy Patients
Official Title Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention 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.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 2, 2012)
0
Original Estimated Enrollment
 (submitted: May 25, 2010)
100
Estimated Study Completion Date July 2013
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01130649
Other Study ID Numbers Epitrack
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John Hixson, University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators San Francisco Veterans Affairs Medical Center
Investigators
Principal Investigator: John Hixson, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2017