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

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055700
• Other study ID #: 0004459
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: Texas A&M University
• Contact: Lei-Shih Chen, PhD
• Phone: 979-862-2912
• Email: lacechen[@]tamu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria -

Women who:

1. age over 18 years old;

2. are able to speak, read and, write English or Spanish;

3. are currently pregnant;

4. have a smartphone with IOS or Android;

5. are current prenatal patients in one of the prenatal clinics in the Driscoll Health System;

6. 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:

1. are unable to speak, read, and write English or Spanish;

2. do not own a smartphone with IOS or Android system.

Related Conditions & MeSH terms

• Genetic Testing
• Mobile Applications
• Pregnant Women
• Prenatal Care

Intervention

Behavioral:
• Mobile app with prenatal genetic testing information
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.

Locations

Country	Name	City	State
United States	Driscoll Children's hospital	Corpus Christi	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas A&M University	Driscoll Children's Hospital, Global Institute for Hispanic Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Uptake of prenatal genetic testing	Participants' decisions on prenatal genetic testing by reviewing participants' medical charts.	Within one year after the intervention.
Secondary	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.
Secondary	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.
Secondary	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.