NCT01833234

Brief Summary

The investigators are developing a questionnaire that can quickly measure the impact that epilepsy has on a person's life. This questionnaire will be useful in following whether the impact of epilepsy increases, decreases or stays the same over time. The results also may point out areas that would benefit from discussion or attention in visits with your doctor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

March 29, 2013

Last Update Submit

April 12, 2016

Conditions

Keywords

epilepsyquality of lifeseizure severityantiepileptic drug side effectsquestionnairepatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Validation of a concise question set

    Up to 1 year for question set validation, data presentation within up to 1.5 years

Secondary Outcomes (1)

  • Correlation of subscales

    Up to 1.5 years

Study Arms (1)

People with epilepsy

People with epilepsy who have have had at least one seizure in the prior year.

Other: Interviews and questionnaires

Interventions

People with epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the Stanford Epilepsy Center who have had a seizure in the past year and agree to participate.

You may qualify if:

  • Age 18 or more.
  • Patient has had at least 1 seizure in the past 365 days.
  • Patient can speak and understand English.

You may not qualify if:

  • Patients suspected of having one of the imitators of epilepsy, for example, syncope, sleep disorder, psychogenic nonepileptic seizures, will be excluded, even if they also have epileptic seizures.
  • Patients unwilling to spend the time doing the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305-5235, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert S Fisher, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 16, 2013

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations