Contraception Decision Aid Use and Patient Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Decisional Conflict
研究概览
简要总结
The purpose of this study is to assess the impact of a contraception decision aid mobile application on: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.
详细描述
After being informed about the study and the potential risks, all participants giving written informed consent will be randomly assigned in a double-blind manner (participant and investigator) in a 1:1 ratio to complete an interactive contraception decision aid health questionnaire (Tuune) or a standard medical questionnaire (Control). After, all participants will be asked questions assessing: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be condition-blind (i.e., they will not be told whether the health application they use is the "treatment" or "control" application). Assignment to treatment arms will be randomized using Qualtrics Experimental Software and treatment assignment group will remain masked to the investigator and those in charge of data analysis until after data analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 18 to 34 years of age who enroll to participate in the study, which will take place on the campus of Texas Christian University.
排除标准
- •Women who are currently pregnant or breastfeeding.
- •Women who wish to become pregnant within the next 12 months.
结局指标
主要结局
Decisional Conflict
时间窗: Immediately upon completion of the assigned health questionnaire.
Decisional conflict about contraceptive use will be measured using a modified version of the "Traditional Decisional Conflict Scale" to assess decisional conflict about birth control use. The modified version of this scale is a 13-item measure utilizing a 1-7 rating scale (1 = strongly disagree \| 7 = strongly agree) asking participants about their decisional conflict with respect to birth control. Higher scores on this scale indicate less decisional conflict about birth control use. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ References: O'Connor AM (1995). Validation of a decisional conflict scale. Medical Decision Making, 15(1), 25-30. doi: 10.1177/0272989X9501500105.
Reproductive Health Self-Efficacy
时间窗: Immediately upon completion of the assigned health questionnaire.
Reproductive health self-efficacy will be measured using a modified version of the "Menstrual Attitudes Questionnaire". The modified version is a 9-item measure utilizing a 1-7 rating scale (1 = strongly disagree \| 7 = strongly agree) asking participants about their menstrual cycle and hormonal self-efficacy. Higher scores indicate lower reproductive health self-efficacy. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/ References: Brooks-Gunn, J., \& Ruble, D. N. (1980). The Menstrual Attitude Questionnaire. Psychosomatic Medicine, 42(5), 503-512. https://doi.org/10.1097/00006842-198009000-00005
Contraceptive Use Intentions
时间窗: Immediately upon completion of the assigned health questionnaire.
Contraceptive use intentions will be measured by asking participants to rate their likelihood of using hormonal birth control in the next week, month, and year. Each question will be measured on a 1-7 scale (1 = extremely unlikely to use \| 7 = extremely likely to use). Higher scores indicate higher use intentions. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/
Reproductive Health and Contraceptive Knowledge
时间窗: Immediately upon completion of the assigned health questionnaire.
Reproductive health and contraceptive knowledge will be measured using the following 6-item, 1-7 rating scale (1 = strongly disagree \| 7 = strongly agree). Higher scores indicate greater reproductive health and contraceptive knowledge. A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/
次要结局
- Patient Satisfaction(Immediately upon completion of the primary measures.)
研究者
Sarah Hill
Professor
Texas Christian University