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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01833234
Other study ID # Stanford Epilepsy IRB 20523
Secondary ID
Status Completed
Phase N/A
First received March 29, 2013
Last updated April 12, 2016
Start date July 2012
Est. completion date September 2014

Study information

Verified date April 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Interviews and questionnaires


Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University James & Carrie Anderson Fund for Research in Epilepsy

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of a concise question set Up to 1 year for question set validation, data presentation within up to 1.5 years No
Secondary Correlation of subscales 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 No
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