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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuune | Experimental | Participants complete the Tuune contraceptive decision aid health questionnaire. |
|
| Control | Active Comparator | Participants complete a standard physician intake health questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuune health questionnaire | Behavioral | Participants complete the Tuune contraceptive decision aid health questionnaire. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah E Hill, PhD | Contact | 8172576424 | s.e.hill@tcu.edu | |
| Summer Mengelkoch, MS | Contact | 817-257-4898 | s.mengelkoch@tcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Hill, PhD | Texas Christian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Christian University | Recruiting | Fort Worth | Texas | 76129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7898294 | Background | O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. | |
| 7465737 | Background | Brooks-Gunn J, Ruble DN. The menstrual attitude questionnaire. Psychosom Med. 1980 Sep;42(5):503-12. doi: 10.1097/00006842-198009000-00005. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 19, 2022 | |
| Reset | Feb 20, 2023 | |
| Release | Apr 10, 2023 | |
| Reset | Jan 11, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2022 | Feb 20, 2023 | |||
| Apr 10, 2023 |
| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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Parallel
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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.
| Control health questionnaire | Behavioral | Participants complete a standard physician intake health questionnaire. |
|
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. |
| Immediately upon completion of the primary measures. |
| 28242516 | Background | 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. |
| 38828482 | Derived | 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. |
| Jan 11, 2024 |