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Epilepsy Impact Scale

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 29, 2013
First Posted Date April 16, 2013
Last Update Posted Date April 13, 2016
Study Start Date July 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2013)
Validation of a concise question set [ Time Frame: Up to 1 year for question set validation, data presentation within up to 1.5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2013)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epilepsy Impact Scale
Official Title Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Other: Interviews and questionnaires
Study Groups/Cohorts People with epilepsy
People with epilepsy who have have had at least one seizure in the prior year.
Intervention: Other: Interviews and questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2016)
51
Original Estimated Enrollment
 (submitted: April 12, 2013)
60
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01833234
Other Study ID Numbers Stanford Epilepsy IRB 20523
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert S. Fisher, M.D., Ph.D., Stanford University
Study Sponsor Stanford University
Collaborators James & Carrie Anderson Fund for Research in Epilepsy
Investigators
Principal Investigator: Robert S Fisher, MD, PhD Stanford University
PRS Account Stanford University
Verification Date April 2016