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
  Purpose

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.


Condition
Epileptic Seizures

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 560
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Seniors with Seizures
Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351727

Contacts
Contact: Jenny Chong, PhD 520 626 1986 jchong@u.arizona.edu
Contact: Jim O'Rourke 520 626 4167 epilepsy@neurology.arizona.edu

Locations
United States, Arizona
Pima, Cochise, Santa Cruz Counties Recruiting
Tucson, Arizona, United States, 85724
Contact: Jenny Chong, PhD    520-626-1986    jchong@u.arizona.edu   
Contact: Jim O'Rourke    520 626 4167    jorourke@email.arizona.edu   
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: David Labiner, MD University of Arizona
Principal Investigator: Jenny Chong, PhD University of Arizona
  More Information

Publications:
Responsible Party: Jenny Chong, Research Associate Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT01351727     History of Changes
Other Study ID Numbers: 10-0916-01
Study First Received: May 9, 2011
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Arizona:
seniors
seizures
epilepsy
quality of life

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014