Contraception Decision Aid Use and Patient Outcomes

NCT ID: NCT05177783

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-08-30

Brief Summary

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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

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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.

Conditions

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Contraceptive Usage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Parallel
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Tuune

Participants complete the Tuune contraceptive decision aid health questionnaire.

Group Type EXPERIMENTAL

Tuune health questionnaire

Intervention Type BEHAVIORAL

Participants complete the Tuune contraceptive decision aid health questionnaire.

Control

Participants complete a standard physician intake health questionnaire.

Group Type ACTIVE_COMPARATOR

Control health questionnaire

Intervention Type BEHAVIORAL

Participants complete a standard physician intake health questionnaire.

Interventions

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Tuune health questionnaire

Participants complete the Tuune contraceptive decision aid health questionnaire.

Intervention Type BEHAVIORAL

Control health questionnaire

Participants complete a standard physician intake health questionnaire.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Christian University

OTHER

Sponsor Role lead

Responsible Party

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Sarah Hill

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Christian University

Locations

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Texas Christian University

Fort Worth, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah E Hill, PhD

Role: CONTACT

8172576424

Summer Mengelkoch, MS

Role: CONTACT

817-257-4898

Facility Contacts

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Sarah Hill, PhD

Role: primary

512-417-5714

References

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

Reference Type BACKGROUND
PMID: 7898294 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7465737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28242516 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38828482 (View on PubMed)

Other Identifiers

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TCU020519781

Identifier Type: -

Identifier Source: org_study_id

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