Contraception Decision Aid Use and Patient Outcomes

Contraceptive Usage Clinical Trial

Official title:

Contraception Decision Aid Use and Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177783
• Other study ID #: TCU020519781
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2022
• Source: Texas Christian University
• Contact: Sarah E Hill, PhD
• Phone: 8172576424
• Email: s.e.hill[@]tcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women who are currently pregnant or breastfeeding.
• Women who wish to become pregnant within the next 12 months.

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Behavioral:
• Tuune health questionnaire
Participants complete the Tuune contraceptive decision aid health questionnaire.
• Control health questionnaire
Participants complete a standard physician intake health questionnaire.

Locations

Country	Name	City	State
United States	Texas Christian University	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med. 1980 Sep;42(5):503-12. — View Citation

O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. — View Citation

Zimmerman M, Gazarian D, Multach M, Attiullah N, Benoff T, Boerescu DA, Friedman MA, Mehring LB, Moon S, Patel S, Holst CG. A clinically useful self-report measure of psychiatric patients' satisfaction with the initial evaluation. Psychiatry Res. 2017 Jun;252:38-44. doi: 10.1016/j.psychres.2017.02.036. Epub 2017 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict	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.	Immediately upon completion of the assigned health questionnaire.
Primary	Reproductive Health Self-Efficacy	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	Immediately upon completion of the assigned health questionnaire.
Primary	Reproductive Health and Contraceptive Knowledge	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/	Immediately upon completion of the assigned health questionnaire.
Primary	Contraceptive Use Intentions	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/	Immediately upon completion of the assigned health questionnaire.
Secondary	Patient Satisfaction	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.	Immediately upon completion of the primary measures.