Clinical trial NCT01351727: Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors
Official title: Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epileptic Seizures
Keywords: seniors
seizures
epilepsy
quality of life
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-05-11
Enrollment: 97
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Seizure dues to hyponatremia, hypoglycemia, alcohol use (with no evidence of other seizures)

Primary outcomes:
measure: A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona.
timeFrame: Up to four years
Secondary outcomes:
measure: Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy
timeFrame: Up to four years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pima, Cochise, Santa Cruz Counties
state: Arizona
Study officials:
affiliation: University of Arizona
name: David Labiner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Jenny Chong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pallin 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.
citation: Tallis 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.