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Prenatal Genetics Chatbot Trial: Prenatal GENEie

ConditionGenetic Counseling
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English or Spanish speaking with ability to read and write

Gestational age <20 weeks

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

Disqualifiers

Patients who have already had genetic counseling related to current pregnancy

h/o trisomy, major fetal anomaly. or aneuploidy in previous pregnancy

Parent with Robertsonian translocation

Twins, vanishing twin, multi-gestation pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prenatal GENEie Chatbot

    Other intervention

    Patient Educational Phone Chatbot Application for Prenatal Genetics in English \& Spanish

  • In-person genetic counseling

    Other intervention

    Standard in-person genetic counseling for prenatal genetics education

Treatment groups

1,470 Participants
are divided into 2 treatment groups
Group A: In-person genetic counselingActive comparator 1 intervention
Group B: Prenatal Genetics Chatbot- Prenatal GENEieExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Prenatal Knowledge Score

The prenatal knowledge score is calculated from questionnaire with 30 true/false questions. The scores range from 0 (lowest knowledge) to 30 (highest knowledge), reflecting the number of correct responses.. The change in prenatal knowledge score is then calculated from the percent answered correctly after the intervention from number of correct responses before the intervention. The highest knowledge increase is 30 and the lowest is 0.

Time frame
Baseline knowledge at enrollment and within 7 days after intervention
2

Rate of Prenatal Screening

Proportion of patients who have had cfDNA screening during pregnancy

Time frame
Assessed between enrollment and 24 weeks gestation

Secondary outcomes

1

Rate of Any Prenatal Screening or Diagnostic Testing

Proportion of patients who have any kind of genetic testing: cfDNA, serum screening, carrier screening, diagnostic testing

Time frame
Assessed between enrollment and 24 weeks gestation
2

Decisional-conflict scale

The Decisional-conflict scale consists of 10 items, each with 3 response categories (yes, no, unsure). Items are given a score value of (0=yes, 2=unsure, 4=no). Total score is calculated by summing items, dividing by 10 and multiplying by 25. Score ranges from 0 (no conflict) to 100 (highest decisional conflict) with higher scores indicating higher level of decisional conflict.

Time frame
Within 7 days after intervention
3

Satisfaction Scale for Educational Intervention

Likert Scale for Satisfaction with genetic counseling or chatbot (secondary outcomes to be described in secondary manuscripts). The Likert scale is 1 to 5 with 1= not at all satisfied with the educational intervention to 5=highly satisfied with educational intervention

Time frame
Within 7 days after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women and Infants Hospital of Rhode Island

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: