Remote Tracking of Epilepsy Patients

NCT01130649 | Withdrawn

• 1 other identifier: Epitrack
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; Tracking; Electronic diary

Outcome Measures

Primary Outcomes (3)

• Seizure frequency per month

  Assessment of seizure count accuracy by assessing total number of seizures reported per month

  1 year

• Medication compliance

  Assessment of compliance with taking medications at regularly scheduled intervals

  1 year

• Quality of life

  Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures

  1 year

Study Arms (2)

Epilepsy patients, electronic diary

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

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

Interventions

HealthBuddy 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.

Also known as: 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

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Recent problem with substance abuse.

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (1)

Univ of California San Fran

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Hixson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 26, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2013
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)