Clinical trial NCT05177783: Contraception Decision Aid Use and Patient Outcomes
Official title: Contraception Decision Aid Use and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraceptive Usage
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Parallel
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decisional Conflict
timeFrame: Immediately upon completion of the assigned health questionnaire.
measure: Reproductive Health Self-Efficacy
timeFrame: Immediately upon completion of the assigned health questionnaire.
measure: Reproductive Health and Contraceptive Knowledge
timeFrame: Immediately upon completion of the assigned health questionnaire.
measure: Contraceptive Use Intentions
timeFrame: Immediately upon completion of the assigned health questionnaire.
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Immediately upon completion of the primary measures.
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Texas Christian University
name: Sarah Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
citation: Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med. 1980 Sep;42(5):503-12. doi: 10.1097/00006842-198009000-00005.
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.