跳至主要内容
临床试验/NCT02485756
NCT02485756已完成不适用

An Educational Intervention to Increase Knowledge of Drug-drug Interactions Between Antiepileptics and Hormonal Contraception Among Reproductive-aged Women With Epilepsy.

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Score on 10 question test

研究概览

简要总结

Previous studies have shown that women on anti-seizure medications are not informed about the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs) and certain hormonal contraceptive. The goal of this proposed study is to develop and assess the efficacy of an educational handout for participants on the ways AEDs and certain hormonal contraceptives can interact to alter effectiveness of the medications. Reproductive age women (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient agrees to participate, she will be given a knowledge exam prior to the clinic appointment to establish baseline understanding of hormonal contraceptive and AED interactions and then the participant will be randomized to receive the intervention (educational handout) or the standard of care (no educational handout). Those in participants in the intervention group will read an educational handout on hormonal contraceptives/AED interactions. Those in the standard care group will not receive this handout and the same knowledge exam will be re-administered to all of the participants after they have completed their appointments to check for knowledge comprehension and short-term knowledge retention. A same-day post-test questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED interactions with their gynecologist, neurologist or primary care physician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age of participants: 18-45 years old
  • Gender of participants: Female
  • Ethnic Background: No limitation, will include minorities
  • Health Status: on at least one antiepileptic medication
  • Sexually active with men
  • English speaking

排除标准

  • Currently Pregnant
  • History of hysterectomy or sterilization procedure
  • Removal of both ovaries
  • Cannot read or comprehend English language
  • Unable to provide informed consent
  • Attempting to become pregnant
  • Not sexually active with men
  • No active telephone number for follow-up contact

研究组 & 干预措施

Educational handout

Experimental

Participants in the intervention group will read an educational handout on hormonal contraceptives/antiepileptic interactions.

干预措施: Educational handout (Other)

Control (no educational handout)

No Intervention

Those in the standard care group will not receive the educational handout.

结局指标

主要结局

Score on 10 question test

时间窗: Score on pretest (prior to intervention/standard care) and post-test (after intervention/standard care).

Change in score on knowledge examination (comparison of pretest and posttest score)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Mody

Associate Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验