Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making

Study Overview
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Brief Summary
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Determine the effect of a culturally sensitive prenatal genetic testing (PGT) education intervention delivered via a mobile application on pregnant women's perceptions, knowledge, and uptake of PGT. Our working hypothesis, based on prior studies, is that pregnant women who receive a culturally sensitive intervention to enhance their knowledge and understanding of PGT will feel more confident in their decision-making regarding PGT.

Official Title
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Assessing the Impact of a Mobile App on Pregnant Women's Perceptions, Knowledge, and Uptake of Prenatal Genetic Testing

Conditions
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Pregnant Women, Mobile Applications, Genetic Testing, Prenatal Care

Intervention / Treatment
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* Behavioral: Mobile app with prenatal genetic testing information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Women who: age over 18 years old; are able to speak, read and, write English or Spanish; are currently pregnant; have a smartphone with IOS or Android; are current prenatal patients in one of the prenatal clinics in the Driscoll Health System; were referred to the clinic because they are at high risk of having a baby with genetic conditions (e.g., advanced maternal age, family history, history of delivering affected baby, abnormal blood or ultrasound screening results). Exclusion Criteria - Women who: are unable to speak, read, and write English or Spanish; do not own a smartphone with IOS or Android system.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This arm will review a mobile app to learn information about prenatal genetic testing before their appointment with maternal-fetal medicine specialists. | Behavioral: Mobile app with prenatal genetic testing information<br>* In the intervention group, participants will be asked to download, register, and review a mobile app on their own mobile phones before their appointment with maternal-fetal medicine specialists. This mobile app includes prenatal genetic testing information about amniocentesis, chorionic villus sampling, nuchal translucency screening, cell-free DNA, triple/quad/penta screening, anatomy ultrasound, and carrier screening.<br>|
| No Intervention: Control group<br>This arm will only receive usual care - visit maternal-fetal medicine specialists. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes toward prenatal genetic testing | Measured by a 4-item scale that asks participants how they feel about prenatal genetic testing. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | 
| Knowledge about prenatal genetic testing | Measured by 27 knowledge questions about prenatal genetic testing options' timing, procedures, and purposes. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | 
| Decisional conflicts about prenatal genetic testing | Measured by the modified 5-item SURE Decisional Conflicts scale. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | 
| Uptake of prenatal genetic testing | Participants' decisions on prenatal genetic testing by reviewing participants' medical charts. | Within one year after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological symptom [Anxiety] | Measured by the 6-item sub-scale of Brief Symptom Inventory-18 about anxiety. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | 
| Decision Self-Efficacy about prenatal genetic testing | Measured by the modified 11-item Decision Self-Efficacy scale. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. | 
| Preparation for Decision Making about prenatal genetic testing | Measured by the modified 7-item Preparation for Decision Making scale. | From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists. |