Prenatal GENEie Chatbot for Genetic Counseling

Overseen By Melissa L Russo, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Genetic counseling, Trisomy, Fetal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a chatbot app called Prenatal GENEie, designed to help pregnant women learn about prenatal genetics. The study compares the effectiveness of the chatbot with in-person meetings with genetic counselors. Participants will either use the chatbot or meet with a counselor, then take a test to assess their knowledge of prenatal genetics. It suits pregnant women less than 20 weeks along who speak English or Spanish and have access to a smartphone or tablet. The goal is to determine if both methods aid in making informed decisions about prenatal genetic testing. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research in prenatal care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Prenatal GENEie Chatbot is safe for educating pregnant women about prenatal genetics?

Research shows that using chatbots like Prenatal GENEie in healthcare is generally safe and well-received. Chatbots provide information through conversation-like interactions and are considered low-risk because they mainly offer educational content. Previous studies on chatbots have not reported any major safety issues or negative effects, as they don't involve taking medication or undergoing medical procedures.

The Prenatal GENEie Chatbot, designed to educate about prenatal genetics, is unlikely to cause harm. Its main goal is to help pregnant individuals better understand genetic testing. Although specific safety data from past studies on Prenatal GENEie is unavailable, its lack of physical procedures suggests it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prenatal GENEie Chatbot because it offers a new, tech-forward approach to genetic counseling. Unlike traditional in-person sessions, which require scheduling and sometimes language interpreters, this chatbot allows expectant parents to access information about genetic screenings on their own time and in their preferred language—English or Spanish. This could make genetic counseling more accessible and convenient, potentially reaching a wider audience and providing crucial information faster.

What evidence suggests that the Prenatal GENEie Chatbot and in-person genetic counseling are effective for teaching prenatal genetics?

This trial will compare the Prenatal GENEie chatbot with in-person genetic counseling. Research has shown that the Prenatal GENEie chatbot can educate people about prenatal genetics as effectively as in-person counseling. In one study with 258 English-speaking pregnant women, those who used the chatbot achieved significantly higher knowledge scores afterward. Another study found that using a chatbot before testing improved understanding of prenatal testing options. These findings suggest that the Prenatal GENEie chatbot is a valuable tool for educating pregnant individuals about genetic testing. ^{1 2 4 6 7}

Who Is on the Research Team?

Method Tuuli, MD

Principal Investigator

Women & Infants Hospital in Providence RI

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who are being offered prenatal genetic testing. It aims to help those who may not have extensive formal education or speak languages other than English, and who need information about these tests.

Inclusion Criteria

I can speak, read, and write in English or Spanish.

Gestational age <20 weeks

Access to smartphone or tablet (through personal use or study)

Exclusion Criteria

Fetal anomaly noted in early pregnancy

I have received genetic counseling for my current pregnancy.

One of my parents has a specific genetic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Prenatal GENEie chatbot or have an in-person meeting with a genetic counselor to learn about prenatal genetics

1 week

1 visit (in-person or virtual)

Follow-up

Participants take a test to assess knowledge gain and fill out a survey about their comfort with decision-making regarding prenatal genetic testing

Within 7 days after intervention

Outcome Assessment

Assessment of prenatal screening and diagnostic testing uptake between enrollment and 24 weeks gestation

Up to 24 weeks gestation

What Are the Treatments Tested in This Trial?

Interventions

• In-person genetic counseling
• Prenatal GENEie Chatbot

Trial Overview The study is testing if a chatbot app called Prenatal GENEie can educate on prenatal genetics as effectively as in-person counseling with a genetic counselor. Participants will use the chatbot or meet with a counselor and then take tests to measure their understanding.

How Is the Trial Designed?

Group I: Prenatal Genetics Chatbot- Prenatal GENEie Experimental Treatment 1 Intervention

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.

Group II: In-person genetic counseling Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07077707?aggFilters=status%3Anot

Study Details | NCT07077707 | Prenatal Genetics Chatbot ... The expected outcome of this study is high-quality evidence on the ability of an educational chatbot to equitably increase patient knowledge and uptake of ...

2. trial.medpath.com trial.medpath.com/clinical-trial/a513872d1edc4a94/nct07077707-chatbot-prenatal-genetic-counseling

Prenatal Genetics Chatbot Trial: Prenatal GENEie | MedPath The specific aims of this study are: Aim 1: Determine the effect of Prenatal GENEie on patient knowledge and uptake of prenatal genetic testing, compared to in- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399124004245

Chatbot for patient education for prenatal aneuploidy testing Pre-test education via a chatbot can increase patient knowledge of prenatal testing choices, with high patient and provider satisfaction.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07077707?keyword=%22Chatbot%22

San Mateo Clinical Trial Prenatal Genetics Chatbot Trial Preliminary data from the researchers' randomized trial of 258 English-speaking pregnant people showed significantly higher post-intervention knowledge scores ...

5. withpower.com withpower.com/trial/phase-aneuploidy-2026-b8ba0

Prenatal GENEie Chatbot for Genetic Counseling Trial Overview The study is testing if a chatbot app called Prenatal GENEie can educate on prenatal genetics as effectively as in-person counseling with a ...

6. reporter.nih.gov reporter.nih.gov/project-details/11194281

A Randomized Trial of Chatbot for Prenatal Genetic ... The proposed public health research will yield high-quality evidence on the ability of an educational chatbot to increase patient knowledge and uptake of ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823183

Uptake of Cancer Genetic Services for Chatbot vs Standard ... This randomized clinical trial examines whether chatbot and standard-of-care delivery models are equivalent in completion of pretest cancer ...