NCT05177783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

December 10, 2021

Last Update Submit

April 25, 2022

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Patient Satisfaction

    Immediately upon completion of the primary measures.

Study Arms (2)

Tuune

EXPERIMENTAL

Participants complete the Tuune contraceptive decision aid health questionnaire.

Behavioral: Tuune health questionnaire

Control

ACTIVE COMPARATOR

Participants complete a standard physician intake health questionnaire.

Behavioral: Control health questionnaire

Interventions

Tuune health questionnaireBEHAVIORAL

Participants complete the Tuune contraceptive decision aid health questionnaire.

Tuune
Control health questionnaireBEHAVIORAL

Participants complete a standard physician intake health questionnaire.

Control

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

RECRUITING

Related Publications (4)

  • O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

    PMID: 7898294BACKGROUND

  • Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med. 1980 Sep;42(5):503-12. doi: 10.1097/00006842-198009000-00005.

    PMID: 7465737BACKGROUND

  • 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.

    PMID: 28242516BACKGROUND

  • Espinosa M, Butler SA, Mengelkoch S, Prieto LJ, Russell E, Ramshaw C, Rose-Reneau Z, Remondino M, Nahavandi S, Hill SE. The Impact of a Digital Contraceptive Decision Aid on User Outcomes: Results of an Experimental, Clinical Trial. Ann Behav Med. 2024 Jun 18;58(7):463-473. doi: 10.1093/abm/kaae024.

    PMID: 38828482DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Sarah Hill, PhD

    Texas Christian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Hill, PhD

CONTACT

8172576424s.e.hill@tcu.edu

Summer Mengelkoch, MS

CONTACT

817-257-4898s.mengelkoch@tcu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 5, 2022

Study Start

January 15, 2022

Primary Completion

May 30, 2022

Study Completion

August 30, 2022

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)