Epilepsy Impact Scale | NCT01833234

Studies
Epilepsy Impact Scale

NCT01833234

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 13, 2016Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Interviews and questionnaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Mar 29, 2013

First Submission Date that Met QC Criteria

Apr 12, 2013

First Posted Date

Apr 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert S. Fisher, M.D., Ph.D., Professor of Neurology, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
James & Carrie Anderson Fund for Research in Epilepsy	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
People with epilepsy		People with epilepsy who have have had at least one seizure in the prior year.	Other: Interviews and questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interviews and questionnaires	Other		People with epilepsy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Patients unwilling to spend the time doing the questionnaire.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in the Stanford Epilepsy Center who have had a seizure in the past year and agree to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert S Fisher, MD, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305-5235	United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided