Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

This study is currently recruiting participants.
Verified January 2013 by University of Arizona
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jenny Chong, University of Arizona
ClinicalTrials.gov Identifier:
NCT01351727
First received: May 9, 2011
Last updated: January 14, 2013
Last verified: January 2013

May 9, 2011
January 14, 2013
January 2011
December 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01351727 on ClinicalTrials.gov Archive Site
Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy [ Time Frame: Up to four years ] [ Designated as safety issue: No ]
  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.
Same as current
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Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Epileptic Seizures
Not Provided
Seniors with Seizures
Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
October 2014
December 2013   (final data collection date for primary outcome measure)

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)
Both
65 Years and older
No
Contact: Jenny Chong, PhD 520 626 1986 jchong@u.arizona.edu
Contact: Jim O'Rourke 520 626 4167 epilepsy@neurology.arizona.edu
United States
 
NCT01351727
10-0916-01
No
Jenny Chong, University of Arizona
University of Arizona
Centers for Disease Control and Prevention
Principal Investigator: David Labiner, MD University of Arizona
Principal Investigator: Jenny Chong, PhD University of Arizona
University of Arizona
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP