Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

Epileptic Seizures Clinical Trial

Official title:

Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351727
• Other study ID #: 10-0916-01
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: November 1, 2017
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Epileptic Seizures
• Seizures

Locations

Country	Name	City	State
United States	Pima, Cochise, Santa Cruz Counties	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to four years
Secondary	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.	Up to four years