Contraception Decision Aid Use and Patient Outcomes
- Conditions
- Contraceptive Usage
- Interventions
- Behavioral: Tuune health questionnaireBehavioral: Control health questionnaire
- Registration Number
- NCT05177783
- Lead Sponsor
- Texas Christian University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
- 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.
- Women who are currently pregnant or breastfeeding.
- Women who wish to become pregnant within the next 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Tuune Tuune health questionnaire Participants complete the Tuune contraceptive decision aid health questionnaire. Control Control health questionnaire Participants complete a standard physician intake health questionnaire.
- Primary Outcome Measures
Name Time Method Decisional Conflict 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 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/10.1097/00006842-198009000-00005Contraceptive Use Intentions 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 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/
- Secondary Outcome Measures
Name Time Method Patient Satisfaction Immediately upon completion of the primary measures. Patient satisfaction with the health questionnaire will be measured using an intervention-tailored version of the "Clinical Use Satisfaction Scale". The modified version is a 14-item measure utilizing two 1-7 rating scales. Items 1 - 12 use the following rating scale: 1 = strongly disagree \| 7 = strongly agree. Items 13 - 14 use the scale: 1 = very unlikely \| 7 = very likely. Higher scores indicate greater satisfaction with the health questionnaire.
A full list of items can be viewed on the Open Science Framework, here: https://osf.io/t4sq2/
References:
Zimmerman, M., Gazarian, D., Multach, M., Attiullah, N., Benoff, T., Boerescu, D. A., ... \& Holst, C. G. (2017). A clinically useful self-report measure of psychiatric patients' satisfaction with the initial evaluation. Psychiatry research, 252, 38-44.
Trial Locations
- Locations (1)
Texas Christian University
🇺🇸Fort Worth, Texas, United States