An Educational Intervention to Increase Knowledge of Drug-drug Interactions Between Antiepileptics and Hormonal Contraception Among Reproductive-aged Women With Epilepsy.
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
- 否
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
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)
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
Sheila Mody
Associate Professor
University of California, San Diego
