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Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Jenny Chong, University of Arizona.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351727
First Posted: May 11, 2011
Last Update Posted: January 16, 2013
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
May 9, 2011
May 11, 2011
January 16, 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 ]
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.
A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona. [ Time Frame: 2012-2013 ]
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.
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 ]
  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.
Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy [ Time Frame: 2011- 2014 ]
  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.
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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.
 
Unknown status
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)
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01351727
10-0916-01
No
Not Provided
Not Provided
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