Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

Completed

• Conditions: Epileptic Seizures

• Registration Number: NCT01351727
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona.	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.

Secondary Outcome Measures

Name	Time	Method
Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy	Up to four years	1. Assess the level and ethnic differences in health-related quality of life, mental health, and perceived stigma among seniors with seizures.; 2. Use in-depth interviews to explore issues related to epilepsy and its treatment.; 3. Conduct focus groups with caregivers to learn about their concerns and barriers.

Trial Locations

Locations (1)

Pima, Cochise, Santa Cruz Counties; 🇺🇸 Tucson, Arizona, United States