EpilepsyNCT01130649
Remote Tracking of Epilepsy Patients
An observational study of Epilepsy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- HealthBuddy
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
- Recent problem with substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of California San Fran
San Francisco, California, 94143
About this study
Official title: 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.
- Conditions
- Epilepsy
- Being tested
- HealthBuddy
- Keywords
- Epilepsy, Tracking, Electronic diary
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthBuddyDevice
Also called Healthbuddy is a product of Bosch Healthcare, and is already utilized in many medical institutions around the country, including the VA Health System.
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.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients, electronic diary | Cohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency per month
Assessment of seizure count accuracy by assessing total number of seizures reported per month
Measured: 1 year
Medication compliance
Assessment of compliance with taking medications at regularly scheduled intervals
Measured: 1 year
Quality of life
Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2013 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Principal investigator, John Hixson, University of California, San Francisco
- Investigators
- John Hixson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130649
- Sponsor's protocol ID
- Epitrack
- Status last verified
- May 2017
- First submitted
- 24 May 2010
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT01130649
- Acronym / sponsor ID
- Epitrack
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Tracking, Electronic diary
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients, electronic diary | – | Device: HealthBuddyCohort of epilepsy patient using an electronic diary system to record all seizures, side effects, and medication compliance |
| 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 |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
- Recent problem with substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthBuddyAlso: Healthbuddy is a product of Bosch Healthcare, and is already utilized in many medical institutions around the country, including the VA Health System.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. | Device | Epilepsy patients, electronic diary |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hixson, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency per month (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.