NCT00144001

Brief Summary

Nearly 2% of veterans \>65 are actively treated for epilepsy, and the incidence is projected to increase with the aging of our society. Since commonly used antiepileptic drugs are considered suboptimal for older patients, it is important to understand existing patterns of treatment for older veterans with epilepsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,682

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2000

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

October 1, 2000

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

September 1, 2008

Enrollment Period

3.9 years

First QC Date

August 31, 2005

Last Update Submit

April 6, 2015

Conditions

Epilepsy

Keywords

EpilepsyPharmacoepidemiologyQuality of CareOutcomes

Outcome Measures

Primary Outcomes (1)

  • Type of Antiepileptic drug prescribed for individuals with new onset epilepsy

    Within one year of first epilepsy diagnosis

Study Arms (1)

Group 1

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older veterans (66 years and older) with a new diagnosis of epilepsy between 2000-2004

You may qualify if:

  • Veterans 66 years and older receiving care from the Veterans Health Administration between fiscal years 2000-2004 Diagnosis of epilepsy and receiving anticonvulsant drugs

You may not qualify if:

  • No VA pharmacy data the year prior to epilepsy diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (20)

  • Zeber JE, Copeland LA, Pugh MJ. Variation in antiepileptic drug adherence among older patients with new-onset epilepsy. Ann Pharmacother. 2010 Dec;44(12):1896-904. doi: 10.1345/aph.1P385. Epub 2010 Nov 2.

    PMID: 21045168RESULT

  • Pugh MJ, Tabares J, Finley E, Bollinger M, Tortorice K, Vancott AC. Changes in antiepileptic drug choice for older veterans with new-onset epilepsy: 2002 to 2006. J Am Geriatr Soc. 2011 May;59(5):955-6. doi: 10.1111/j.1532-5415.2011.03388.x. No abstract available.

    PMID: 21568976RESULT

  • Copeland LA, Ettinger AB, Zeber JE, Gonzalez JM, Pugh MJ. Psychiatric and medical admissions observed among elderly patients with new-onset epilepsy. BMC Health Serv Res. 2011 Apr 19;11:84. doi: 10.1186/1472-6963-11-84.

    PMID: 21504584RESULT

  • Pugh MJ, Starner CI, Amuan ME, Berlowitz DR, Horton M, Marcum ZA, Hanlon JT. Exposure to potentially harmful drug-disease interactions in older community-dwelling veterans based on the Healthcare Effectiveness Data and Information Set quality measure: who is at risk? J Am Geriatr Soc. 2011 Sep;59(9):1673-8. doi: 10.1111/j.1532-5415.2011.03524.x. Epub 2011 Aug 10.

    PMID: 21831166RESULT

  • Pugh MJ, Berlowitz DR, Rao JK, Shapiro G, Avetisyan R, Hanchate A, Jarrett K, Tabares J, Kazis LE. The quality of care for adults with epilepsy: an initial glimpse using the QUIET measure. BMC Health Serv Res. 2011 Jan 3;11:1. doi: 10.1186/1472-6963-11-1.

    PMID: 21199575RESULT

  • Brooks DR, Avetisyan R, Jarrett KM, Hanchate A, Shapiro GD, Pugh MJ, Berlowitz DR, Thurman D, Montouris G, Kazis LE. Validation of self-reported epilepsy for purposes of community surveillance. Epilepsy Behav. 2012 Jan;23(1):57-63. doi: 10.1016/j.yebeh.2011.11.002. Epub 2011 Dec 20.

    PMID: 22189155RESULT

  • VanCott AC, Cramer JA, Copeland LA, Zeber JE, Steinman MA, Dersh JJ, Glickman ME, Mortensen EM, Amuan ME, Pugh MJ. Suicide-related behaviors in older patients with new anti-epileptic drug use: data from the VA hospital system. BMC Med. 2010 Jan 11;8:4. doi: 10.1186/1741-7015-8-4.

    PMID: 20064226RESULT

  • Ettinger AB, Copeland LA, Zeber JE, Van Cott AC, Pugh MJ. Are psychiatric disorders independent risk factors for new-onset epilepsy in older individuals? Epilepsy Behav. 2010 Jan;17(1):70-4. doi: 10.1016/j.yebeh.2009.10.010. Epub 2009 Nov 12.

    PMID: 19913462RESULT

  • Pugh MJ, Vancott AC, Steinman MA, Mortensen EM, Amuan ME, Wang CP, Knoefel JE, Berlowitz DR. Choice of initial antiepileptic drug for older veterans: possible pharmacokinetic drug interactions with existing medications. J Am Geriatr Soc. 2010 Mar;58(3):465-71. doi: 10.1111/j.1532-5415.2010.02732.x.

    PMID: 20398114RESULT

  • Pugh MJ, Berlowitz DR, Montouris G, Bokhour B, Cramer JA, Bohm V, Bollinger M, Helmers S, Ettinger A, Meador KJ, Fountain N, Boggs J, Tatum WO 4th, Knoefel J, Harden C, Mattson RH, Kazis L. What constitutes high quality of care for adults with epilepsy? Neurology. 2007 Nov 20;69(21):2020-7. doi: 10.1212/01.WNL.0000291947.29643.9f. Epub 2007 Oct 10.

    PMID: 17928576RESULT

  • Berlowitz DR, Pugh MJ. Pharmacoepidemiology in community-dwelling elderly taking antiepileptic drugs. Int Rev Neurobiol. 2007;81:153-63. doi: 10.1016/S0074-7742(06)81009-3.

    PMID: 17433922RESULT

  • Pugh MJ, Berlowitz DR, Kazis L. The impact of epilepsy on older veterans. Int Rev Neurobiol. 2007;81:221-33. doi: 10.1016/S0074-7742(06)81014-7.

    PMID: 17433927RESULT

  • Zeber JE, Copeland LA, Amuan M, Cramer JA, Pugh MJ. The role of comorbid psychiatric conditions in health status in epilepsy. Epilepsy Behav. 2007 Jun;10(4):539-46. doi: 10.1016/j.yebeh.2007.02.008. Epub 2007 Apr 6.

    PMID: 17416208RESULT

  • Pugh MJ, Knoefel JE, Mortensen EM, Amuan ME, Berlowitz DR, Van Cott AC. New-onset epilepsy risk factors in older veterans. J Am Geriatr Soc. 2009 Feb;57(2):237-42. doi: 10.1111/j.1532-5415.2008.02124.x.

    PMID: 19207140RESULT

  • Hope OA, Zeber JE, Kressin NR, Bokhour BG, Vancott AC, Cramer JA, Amuan ME, Knoefel JE, Pugh MJ. New-onset geriatric epilepsy care: Race, setting of diagnosis, and choice of antiepileptic drug. Epilepsia. 2009 May;50(5):1085-93. doi: 10.1111/j.1528-1167.2008.01892.x. Epub 2008 Nov 17.

    PMID: 19054416RESULT

  • Van Cott AC, Pugh MJ. Epilepsy and the elderly. Annals of Long-Term Care: Clinical Care and Aging. 2008 Jan 1; 16(1):28-32.

    RESULT

  • Pugh MJ, Zeber JE, Copeland LA, Tabares JV, Cramer JA. Psychiatric disease burden profiles among veterans with epilepsy: the association with health services utilization. Psychiatr Serv. 2008 Aug;59(8):925-8. doi: 10.1176/ps.2008.59.8.925.

    PMID: 18678692RESULT

  • Pugh MJ, Van Cott AC, Cramer JA, Knoefel JE, Amuan ME, Tabares J, Ramsay RE, Berlowitz DR; Treatment In Geriatric Epilepsy Research (TIGER) team. Trends in antiepileptic drug prescribing for older patients with new-onset epilepsy: 2000-2004. Neurology. 2008 May 27;70(22 Pt 2):2171-8. doi: 10.1212/01.wnl.0000313157.15089.e6.

    PMID: 18505996RESULT

  • Pugh MJ, Copeland LA, Zeber JE, Cramer JA, Amuan ME, Cavazos JE, Kazis LE. The impact of epilepsy on health status among younger and older adults. Epilepsia. 2005 Nov;46(11):1820-7. doi: 10.1111/j.1528-1167.2005.00291.x.

    PMID: 16302863RESULT

  • Pugh MJ, Foreman PJ, Berlowitz DR. Prescribing antiepileptics for the elderly: differences between guideline recommendations and clinical practice. Drugs Aging. 2006;23(11):861-75. doi: 10.2165/00002512-200623110-00002.

    PMID: 17109565RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mary Jo Pugh, PhD RN

    South Texas Health Care System, San Antonio, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

October 1, 2000

Primary Completion

September 1, 2004

Study Completion

September 1, 2008

Last Updated

April 7, 2015

Record last verified: 2008-09

Locations

US(2)