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

Not Applicable

• Conditions: Mobile Applications; Prenatal Care; Pregnant Women; Genetic Testing
• Interventions: Behavioral: Mobile app with prenatal genetic testing information

• Registration Number: NCT05055700
• Lead Sponsor: Texas A&M University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Mobile app with prenatal genetic testing information	This arm will review a mobile app to learn information about prenatal genetic testing before their appointment with maternal-fetal medicine specialists.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Driscoll Children's hospital; 🇺🇸 Corpus Christi, Texas, United States