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Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

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ClinicalTrials.gov Identifier: NCT01351727
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Jenny Chong, University of Arizona

Tracking Information
First Submitted Date May 9, 2011
First Posted Date May 11, 2011
Last Update Posted Date November 6, 2017
Study Start Date January 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2011)
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.
Original Primary Outcome Measures
 (submitted: May 10, 2011)
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.
Change History Complete list of historical versions of study NCT01351727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 10, 2011)
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.
Original Secondary Outcome Measures
 (submitted: May 10, 2011)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors
Official Title Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors From Different Ethnic Groups
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epileptic Seizures
Intervention Not Provided
Study Groups/Cohorts Seniors with Seizures
Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 1, 2017)
97
Original Estimated Enrollment
 (submitted: May 10, 2011)
560
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01351727
Other Study ID Numbers 10-0916-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jenny Chong, University of Arizona
Study Sponsor University of Arizona
Collaborators Centers for Disease Control and Prevention
Investigators
Principal Investigator: David Labiner, MD University of Arizona
Principal Investigator: Jenny Chong, PhD University of Arizona
PRS Account University of Arizona
Verification Date November 2017