Genetic Testing, Mobile Applications, Pregnant Women, Prenatal Care
Conditions
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
Driscoll Children's Hospital
Global Institute for Hispanic Health
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Uptake of prenatal genetic testing | Within one year after the intervention. | Participants' decisions on prenatal genetic testing by reviewing participants' medical charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed