Epilepsy Impact Scale

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

James & Carrie Anderson Fund for Research in Epilepsy

Information provided by (Responsible Party):

Robert S. Fisher, M.D., Ph.D., Stanford University

ClinicalTrials.gov Identifier:

NCT01833234

First received: March 29, 2013

Last updated: April 12, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition	Intervention
Epilepsy	Other: Interviews and questionnaires


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Validation of a concise question set [ Time Frame: Up to 1 year for question set validation, data presentation within up to 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of subscales [ Time Frame: Up to 1.5 years ] [ Designated as safety issue: No ]
Correlation of subscales of the study questionnaire with previously validated scales, including QoLiE-39, NHS Seizure Severity Scale, Liverpool side effects scale, Beck Depression Index


Estimated Enrollment:	60
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
People with epilepsy People with epilepsy who have have had at least one seizure in the prior year.	Other: Interviews and questionnaires

Detailed Description:

The investigators have used a set of broad open-ended questions about the impact of epilepsy on a person's life to formulate a long list of questions to characterize the impact the seizures, medications, and comorbidities that you are having. In the future, this will be boiled down to a short list of questions.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

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: NCT01833234

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5235

Sponsors and Collaborators

Stanford University

James & Carrie Anderson Fund for Research in Epilepsy

Investigators


Principal Investigator:	Robert S Fisher, MD, PhD	Stanford University

More Information

No publications provided


Responsible Party:	Robert S. Fisher, M.D., Ph.D., Professor of Neurology, Stanford University
ClinicalTrials.gov Identifier:	NCT01833234 History of Changes
Other Study ID Numbers:	Stanford Epilepsy IRB 20523
Study First Received:	March 29, 2013
Last Updated:	April 12, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:


epilepsy quality of life seizure severity	antiepileptic drug side effects questionnaire patient reported outcomes

Additional relevant MeSH terms:


Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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