Contraception Decision Aid Use and Patient Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Contraceptive Usage
• Intervention / Treatment: Behavioral: Tuune health questionnaire; Behavioral: Control health questionnaire

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah E Hill, PhD; Phone Number: 8172576424; Email: s.e.hill@tcu.edu
• Study Contact Backup: Name: Summer Mengelkoch, MS; Phone Number: 817-257-4898; Email: s.mengelkoch@tcu.edu

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76129
      • Recruiting
      • Texas Christian University
      • Contact: Sarah Hill, PhD; Phone Number: 512-417-5714; Email: s.e.hill@tcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tuune; Participants complete the Tuune contraceptive decision aid health questionnaire.	Behavioral: Tuune health questionnaire; Participants complete the Tuune contraceptive decision aid health questionnaire.
ACTIVE_COMPARATOR: Control; Participants complete a standard physician intake health questionnaire.	Behavioral: Control health questionnaire; Participants complete a standard physician intake health questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Sarah Hill, PhD, Texas Christian University

Publications and helpful links

General Publications

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
• Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med. 1980 Sep;42(5):503-12. doi: 10.1097/00006842-198009000-00005.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2022
• Primary Completion (ANTICIPATED): May 30, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (ACTUAL): January 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TCU020519781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No