EpilepsyNCT01833234
Epilepsy Impact Scale
An observational study of Epilepsy, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Interviews and questionnaires
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the Stanford Epilepsy Center who have had a seizure in the past year and agree to participate.
Who may be able to join
- Age 18 or more.
- Patient has had at least 1 seizure in the past 365 days.
- Patient can speak and understand English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305-5235
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Interviews and questionnaires
- Keywords
- epilepsy, quality of life, seizure severity, antiepileptic drug side effects, questionnaire, patient reported outcomes
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| People with epilepsy | People with epilepsy who have have had at least one seizure in the prior year. Receives: Other: Interviews and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a concise question set
Measured: Up to 1 year for question set validation, data presentation within up to 1.5 years
Secondary outcomes (1)
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
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- James & Carrie Anderson Fund for Research in Epilepsy
- Responsible party
- Principal investigator, Robert S. Fisher, M.D., Ph.D., Stanford University
- Investigators
- Robert S Fisher, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833234
- Sponsor's protocol ID
- Stanford Epilepsy IRB 20523
- Status last verified
- Apr 2016
- First submitted
- 29 Mar 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.
- ClinicalTrials.gov ID
- NCT01833234
- Acronym / sponsor ID
- Stanford Epilepsy IRB 20523
- Conditions
- Epilepsy
- Keywords
- epilepsy, quality of life, seizure severity, antiepileptic drug side effects, questionnaire, patient reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- James & Carrie Anderson Fund for Research in Epilepsy
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with epilepsy | – | Other: Interviews and questionnairesPeople with epilepsy who have have had at least one seizure in the prior year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Stanford Epilepsy Center who have had a seizure in the past year and agree to participate.
Key inclusion criteria (3 listed)
- Age 18 or more.
- Patient has had at least 1 seizure in the past 365 days.
- Patient can speak and understand English.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews and questionnaires | Other | People with epilepsy |
Primary outcome
Validation of a concise question set
Time frame: Up to 1 year for question set validation, data presentation within up to 1.5 years
1 secondary outcome
Correlation of subscales
Time frame: Up to 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Fisher, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a concise question set (time frame: Up to 1 year for question set validation, data presentation within up to 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.