Prenatal Genetics Chatbot Trial: Prenatal GENEie
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- Women and Infants Hospital of Rhode Island
- Study ID
- NCT07077707
- Status
- Not Yet Recruiting
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Conditions
- Genetic Counseling
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Prenatal GENEie Chatbot — OTHERPatient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish
- In-person genetic counseling — OTHERStandard in-person genetic counseling for prenatal genetics education
Study Details
During pregnancy, all pregnant people are offered tests to look for genetic conditions in the baby. However, there isn't a standard way of giving this information to patients. Doctors have a lot of things to discuss during the first prenatal visit and don't always have time to explain genetics in detail. Also, not everyone has access to genetic counselors. Prenatal genetics can be confusing, especially for people who haven't had a lot of formal education or who speak languages other than English. There might be misunderstandings about what these tests can find and what their benefits or risks are for these tests. Mobile apps, like chatbots, could be a helpful way to give information about prenatal genetics. Almost everyone has a cell phone, and a chatbot can let people learn at their own speed and whenever they want. The goal of this study is to see if a chatbot app Prenatal GENEie can teach pregnant women about prenatal genetics, and compare the chatbot to talking with a genetic counselor in person. The study wants to answer these main questions: * Does the Prenatal GENEie help pregnant patients learn about prenatal genetics the same way as a meeting with a genetic counselor? * Can the Prenatal GENEie and in-person counseling both help people make decisions about whether they want prenatal genetic testing? The researchers will compare the chatbot Prenatal GENEie with in-person counseling to see if the chatbot teaches people about prenatal genetics in a similar way. Participants will: * Take a test to check what they already know about prenatal genetics prior to the intervention * Use the chatbot or have an in-person meeting with a genetic counselor * Take a test after using the chatbot or meeting with a counselor to see how much their knowledge has improved * Fill out a survey about how comfortable they feel with their decision to do or not do prenatal genetic testing
Key Dates
- Start date
- Jan 1, 2026
- Status verified
- Jul 2025
- Primary completion
- Mar 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 1,470 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: In-person genetic counselingPatients in this group will be scheduled for an in-person genetic counseling visit to discuss options for aneuploidy screening, carrier screening, and prenatal diagnosis. For Spanish-speaking patients the genetic counselors will use in-person interpreters.
- Experimental: Prenatal Genetics Chatbot- Prenatal GENEiePatients in the intervention group will be assisted by research staff to download and interact with the chatbot Prenatal GENEie in their preferred language (English or Spanish) for a minimum of 30 minutes to learn about aneuploidy screening, carrier screening and prenatal diagnosis.
Primary Outcome Measure
Change in Prenatal Knowledge Score [ Time Frame: Baseline knowledge at enrollment and within 7 days after intervention ]
Central Contacts
- Melissa L Russo, MD2022360080
- Sayda D Moran Cordon, BA(401) 274-1122
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | - |
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