Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557) (ECOS)
2022年2月2日 更新者:Organon and Co
Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives
Physicians counsel women participants who are candidates for hormonal contraception about available combined hormonal contraceptive methods (the combined pill, the contraceptive vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive transdermal patch).
Effects of this counseling on women's contraceptive use decisions are to be evaluated by 1) recording which method is chosen after information is provided about all three available combined hormonal methods, 2) comparing the final chosen contraceptive method used by a participant after counseling with the method originally intended to be used by that participant before the counseling, and 3) evaluating the criteria used by women participants to choose their contraceptive method after the counseling, including evaluation of social and demographic predictors of contraceptive choice.
The differences among participants in the number of contacts made by the participants to physician offices for purposes of obtaining information regarding the use of their final chosen hormonal contraceptive (e.g., requests for clarification, questions, expressing doubt or reservations for using the method, or requests for other help/advisement by the physician) will also be evaluated over four months following the physician counseling.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
1919
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for information on contraception choices
描述
Inclusion Criteria:
- Healthy women ≥ 18 years of age and ≤ 40 years of age who consult their physician for contraception and would consider a combined hormonal contraceptive method
- Women who are using the hormonal method for the first time or who have previously used and suspended it for at least 1 month
- Women on one combined pill who would consider switching to another combined pill (Women who attend their physician to stop one of the combined hormonal methods can not participate)
- Women who request a combined hormonal contraceptive method but for whom the physician considers another method more appropriate (e.g. contraindications for combined hormonal contraception) will be counseled about these methods but still complete the questionnaire
- Women who are not interested in becoming pregnant in the next 4 months
- Women who agree to complete a questionnaire and that the questionnaire data are reviewed and analyzed by staff participating in the project
Exclusion Criteria:
None
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
All Qualified Participants
All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling
大体时间:Day of inclusion (Day 0) prior to physician counseling and after physician counseling
|
Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose.
This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.
|
Day of inclusion (Day 0) prior to physician counseling and after physician counseling
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method
大体时间:Up to four months after the counseling visit
|
Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded.
Participants who called back more than once were counted overall and for each method of contraception.
|
Up to four months after the counseling visit
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2010年8月12日
首先提交符合 QC 标准的
2010年8月12日
首次发布 (估计)
2010年8月13日
研究记录更新
最后更新发布 (实际的)
2022年2月4日
上次提交的符合 QC 标准的更新
2022年2月2日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.