Epileptic SeizuresNCT01351727
Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors
An observational study of Epileptic Seizures, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this proposed research is to identify individuals in southeastern Arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Epileptic Seizures
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitals (including emergency departments), neurology specialist clinics, primary care clinics, communities (in Cochise, Pima, Santa Cruz Counties)including nursing homes, skilled nursing facilities, assisted living facilities.
Who may be able to join
- Aged 65 years or older
- New onset seizure or newly diagnosed epilepsy as of October 2010
- Is a resident of Pima, Cochise or Santa Cruz County
Who cannot join
- Seizure dues to hyponatremia, hypoglycemia, alcohol use (with no evidence of other seizures)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pima, Cochise, Santa Cruz Counties
Tucson, Arizona, 85724
About this study
Official title: Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups
The purpose of this proposed research is to identify individuals in southeastern Arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. In doing so the investigators will be able to describe the public health burden of this condition and to identify factors that predict clinical outcomes and health care needs in this population, using quantitative, administrative, and qualitative data. The aims of this proposed research are 1) to determine the two-year incidence of newly diagnosed epilepsy in the target population, 2) describe health care resource utilization of the target population using Medicare data, 3) validate the use of Medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of this condition in different ethnic groups.
Read the detailed description
Seniors who have had new onset seizures or newly diagnosed epilepsy will be recruited from emergency departments (EDs), neurology clinics, primary care clinics (including geriatric clinics), and other service providers from networks maintained by the Area Agencies on Aging that serve seniors in southeastern Arizona. Data will be collected in the form of bi-annual surveys,administrative data (from Medicare), in-depth interviews, and focus groups. Medicare data will be used to describe and evaluate the likelihood of being hospitalized or admitted to a long-term facility within two years of being diagnosed, medication adherence and persistence, and comparing the cost of care between the newly-diagnosed seniors with epilepsy and comparable seniors who do not have epilepsy. The feasibility and validity of using the Medicare claims data to estimate newly diagnosed epilepsy will also be assessed. Finally, the impact of epilepsy on health related quality of life, mental health, perceived stigma, and family and caregivers will also be evaluated through surveys and qualitative data collection methods, and ethnic differences will also be described.
- Conditions
- Epileptic Seizures
- Keywords
- seniors, seizures, epilepsy, quality of life
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Seniors with Seizures | Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona.
A surveillance mechanism will be developed to identify and recruit seniors from emergency departments, neurology clinics, primary care clinics, and other service providers for seniors.
Measured: Up to four years
Secondary outcomes (1)
Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy
- Assess the level and ethnic differences in health-related quality of life, mental health, and perceived stigma among seniors with seizures.
- Use in-depth interviews to explore issues related to epilepsy and its treatment.
- Conduct focus groups with caregivers to learn about their concerns and barriers.
Measured: Up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epileptic SeizuresStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jenny Chong, University of Arizona
- Investigators
- David Labiner, MD, Principal investigator, University of ArizonaJenny Chong, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351727
- Sponsor's protocol ID
- 10-0916-01
- Status last verified
- Nov 2017
- First submitted
- 9 May 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin R, Vogtle L, Gilliam F, Faught E. What are the concerns of older adults living with epilepsy? Epilepsy Behav. 2005 Sep;7(2):297-300. doi: 10.1016/j.yebeh.2005.05.003.
PubMed 15996527Pallin DJ, Goldstein JN, Moussally JS, Pelletier AJ, Green AR, Camargo CA Jr. Seizure visits in US emergency departments: epidemiology and potential disparities in care. Int J Emerg Med. 2008 Jun;1(2):97-105. doi: 10.1007/s12245-008-0024-4. Epub 2008 Jun 5.
PubMed 19384659Tallis R, Hall G, Craig I, Dean A. How common are epileptic seizures in old age? Age Ageing. 1991 Nov;20(6):442-8. doi: 10.1093/ageing/20.6.442.
PubMed 1776595
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups
- ClinicalTrials.gov ID
- NCT01351727
- Acronym / sponsor ID
- 10-0916-01
- Conditions
- Epileptic Seizures
- Keywords
- seniors, seizures, epilepsy, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 May 2011 (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 purpose of this proposed research is to identify individuals in southeastern Arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. In doing so the investigators will be able to describe the public health burden of this condition and to identify factors that predict clinical outcomes and health care needs in this population, using quantitative, administrative, and qualitative data. The aims of this proposed research are 1) to determine the two-year incidence of newly diagnosed epilepsy in the target population, 2) describe health care resource utilization of the target population using Medicare data, 3) validate the use of Medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of this condition in different ethnic groups.
Detailed description
Seniors who have had new onset seizures or newly diagnosed epilepsy will be recruited from emergency departments (EDs), neurology clinics, primary care clinics (including geriatric clinics), and other service providers from networks maintained by the Area Agencies on Aging that serve seniors in southeastern Arizona. Data will be collected in the form of bi-annual surveys,administrative data (from Medicare), in-depth interviews, and focus groups. Medicare data will be used to describe and evaluate the likelihood of being hospitalized or admitted to a long-term facility within two years of being diagnosed, medication adherence and persistence, and comparing the cost of care between the newly-diagnosed seniors with epilepsy and comparable seniors who do not have epilepsy. The feasibility and validity of using the Medicare claims data to estimate newly diagnosed epilepsy will also be assessed. Finally, the impact of epilepsy on health related quality of life, mental health, perceived stigma, and family and caregivers will also be evaluated through surveys and qualitative data collection methods, and ethnic differences will also be described.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seniors with Seizures | – | –Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitals (including emergency departments), neurology specialist clinics, primary care clinics, communities (in Cochise, Pima, Santa Cruz Counties)including nursing homes, skilled nursing facilities, assisted living facilities.
Key inclusion criteria (3 listed)
- Aged 65 years or older
- New onset seizure or newly diagnosed epilepsy as of October 2010
- Is a resident of Pima, Cochise or Santa Cruz County
Key exclusion criteria (1 listed)
- Seizure dues to hyponatremia, hypoglycemia, alcohol use (with no evidence of other seizures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona.
Time frame: Up to four years
A surveillance mechanism will be developed to identify and recruit seniors from emergency departments, neurology clinics, primary care clinics, and other service providers for seniors.
1 secondary outcome
Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy
Time frame: Up to four 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 6 Nov 2017.
- Background: PubMed 15996527Martin R, Vogtle L, Gilliam F, Faught E. What are the concerns of older adults living with epilepsy? Epilepsy Behav. 2005 Sep;7(2):297-300. doi: 10.1016/j.yebeh.2005.05.003.
- Background: PubMed 19384659Pallin DJ, Goldstein JN, Moussally JS, Pelletier AJ, Green AR, Camargo CA Jr. Seizure visits in US emergency departments: epidemiology and potential disparities in care. Int J Emerg Med. 2008 Jun;1(2):97-105. doi: 10.1007/s12245-008-0024-4. Epub 2008 Jun 5.
- Background: PubMed 1776595Tallis R, Hall G, Craig I, Dean A. How common are epileptic seizures in old age? Age Ageing. 1991 Nov;20(6):442-8. doi: 10.1093/ageing/20.6.442.
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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.
David Labiner, MD principal investigator
University of Arizona
Jenny Chong, PhD principal investigator
University of Arizona
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 Epileptic Seizures, run by University of Arizona 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 1 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 6 Nov 2017. 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?
A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona. (time frame: Up to four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351727, which also lists 3 linked publications.
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 6 Nov 2017.