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Epilepsy Impact Scale

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ClinicalTrials.gov Identifier: NCT01833234
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
James & Carrie Anderson Fund for Research in Epilepsy
Information provided by (Responsible Party):
Robert S. Fisher, M.D., Ph.D., Stanford University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Epilepsy 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.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.
Study Start Date : July 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
People with epilepsy
People with epilepsy who have have had at least one seizure in the prior year.
 Other: Interviews and questionnaires


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Validation of a concise question set [ Time Frame: Up to 1 year for question set validation, data presentation within up to 1.5 years ]

Secondary Outcome Measures :
  1. Correlation of subscales [ Time Frame: Up to 1.5 years ]
    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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

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

Exclusion Criteria:

  1. 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.
  2. Patients unwilling to spend the time doing the questionnaire.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Robert S. Fisher, M.D., Ph.D., 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