Clinical trial NCT05055700: Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making
Official title: Assessing the Impact of a Mobile App on Pregnant Women's Perceptions, Knowledge, and Uptake of Prenatal Genetic Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women
Mobile Applications
Genetic Testing
Prenatal Care
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Driscoll Children's Hospital
name: Global Institute for Hispanic Health
First posted: 2021-09-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Attitudes toward prenatal genetic testing
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
measure: Knowledge about prenatal genetic testing
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
measure: Decisional conflicts about prenatal genetic testing
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
measure: Uptake of prenatal genetic testing
timeFrame: Within one year after the intervention.
Secondary outcomes:
measure: Psychological symptom [Anxiety]
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
measure: Decision Self-Efficacy about prenatal genetic testing
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
measure: Preparation for Decision Making about prenatal genetic testing
timeFrame: From the time of enrollment to two weeks after the participants' appointment with maternal-fetal medicine specialists.
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: Driscoll Children's hospital
state: Texas
Study officials:
affiliation: Texas A&M University
name: Lei-Shih Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas A&M University
name: Robin Page
role: PRINCIPAL_INVESTIGATOR
References: