NCT01351727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

May 9, 2011

Last Update Submit

November 1, 2017

Conditions

Keywords

seniorsseizuresepilepsyquality of life

Outcome Measures

Primary Outcomes (1)

  • A two-year incidence rate of new-onset seizures and/or newly-diagnosed epilepsy among seniors in southeastern Arizona.

    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.

    Up to four years

Secondary Outcomes (1)

  • Compare the impact of epilepsy on the different ethnic groups of seniors with epilepsy

    Up to four years

Study Arms (1)

Seniors with Seizures

Seniors aged 65 or older with newly diagnosed seizures (consistent with epilepsy) or epilepsy as of October, 2010.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Seizure dues to hyponatremia, hypoglycemia, alcohol use (with no evidence of other seizures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pima, Cochise, Santa Cruz Counties

Tucson, Arizona, 85724, United States

Location

Related Publications (3)

  • Martin R, Vogtle L, Gilliam F, Faught E. What are the concerns of older adults living with epilepsy? Epilepsy Behav. 2005 Sep;7(2):297-300. doi: 10.1016/j.yebeh.2005.05.003.

    PMID: 15996527BACKGROUND
  • Pallin DJ, Goldstein JN, Moussally JS, Pelletier AJ, Green AR, Camargo CA Jr. Seizure visits in US emergency departments: epidemiology and potential disparities in care. Int J Emerg Med. 2008 Jun;1(2):97-105. doi: 10.1007/s12245-008-0024-4. Epub 2008 Jun 5.

    PMID: 19384659BACKGROUND
  • Tallis R, Hall G, Craig I, Dean A. How common are epileptic seizures in old age? Age Ageing. 1991 Nov;20(6):442-8. doi: 10.1093/ageing/20.6.442.

    PMID: 1776595BACKGROUND

MeSH Terms

Conditions

SeizuresEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • David Labiner, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR
  • Jenny Chong, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 11, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations