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Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351727
First Posted: May 11, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Jenny Chong, University of Arizona
  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 Jenny Chong, 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 ]
    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 ]
    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.


Enrollment: 97
Study Start Date: January 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351727


Locations
United States, Arizona
Pima, Cochise, Santa Cruz Counties
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Centers for Disease Control and Prevention
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
First Submitted: May 9, 2011
First Posted: May 11, 2011
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Jenny Chong, 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