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
  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:


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:

  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
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 August 20, 2014