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 — OTHER
    Patient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish
  • In-person genetic counseling — OTHER
    Standard 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 counseling
    Patients 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 GENEie
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905-

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