Epilepsy Impact Scale

April 12, 2016 updated by: Robert S. Fisher, M.D., Ph.D., Stanford University

Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of a concise question set
Time Frame: Up to 1 year for question set validation, data presentation within up to 1.5 years
Up to 1 year for question set validation, data presentation within up to 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

James & Carrie Anderson Fund for Research in Epilepsy

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stanford Epilepsy IRB 20523

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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