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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women; Mobile Applications; Prenatal Care; Genetic Testing
• Intervention / Treatment: Behavioral: Mobile app with prenatal genetic testing information

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei-Shih Chen, PhD; Phone Number: 979-862-2912; Email: lacechen@tamu.edu
• Study Contact Backup: Name: Robin Page, PhD; Phone Number: 979-436-0147; Email: rpage@tamu.edu

Study Locations

• United States
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Recruiting
      • Driscoll Children's Hospital
      • Contact: Ronald Jaekle, MD; Phone Number: 361-980-1248; Email: Ron.Jaekle@dchstx.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Control group; This arm will only receive usual care - visit maternal-fetal medicine specialists.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Driscoll Children's Hospital; Global Institute for Hispanic Health
• Investigators: Principal Investigator: Lei-Shih Chen, PhD, Texas A&M University; Principal Investigator: Robin Page, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0004459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No