Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

Pregnancy Clinical Trial

Official title:

Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication to Reduce Disparities in Maternal and Child Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053515
• Other study ID #: 5R01MD016037-03
• Secondary ID: 5R01MD016037-033
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of Maryland, College Park
• Contact: Quynh C Nguyen, PhD
• Phone: 3014056425
• Email: qtnguyen[@]umd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.

Description:

This study will examine whether the use of a chatbot to impart health information to minority women during pregnancy and postpartum period improves health care seeking behavior and maternal and infant health outcomes. This study does not involve administration of an investigational intervention and therefore poses minimal risk to participants.

Aim 1: Develop technology for a "chatbot" that will provide health information support to vulnerable mothers the moment they need it.

Aim 2: Evaluate the use of Rosie on maternal and infant outcomes. Aim 3: Release an open-source packet for the construction of a chatbot.

• Participants in the study will be randomly assigned into one of two groups, Rosie the Chatbot group (treatment group) and Book Club group (control group).

• Participants in the Rosie the Chatbot Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will be expected to actively use the chatbot app by asking questions related to maternal and infant health and selecting "thumbs up or thumbs down" to provide feedback for questions' response and use the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).

• Participants in the Book Club Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will receive a monthly children's book, which they are expected to read with baby if parenting or individually if pregnant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age 14 years and older

• Racial minority women

• Pregnant or has an infant < 6 months

• Must be able to read English or Spanish

Exclusion Criteria:

• Mother younger than 14 years of age at time of child's birth.

• Non-hispanic white

Related Conditions & MeSH terms

• Depression, Postpartum
• Infant Conditions
• Infant Development
• Postpartum Depression
• Pregnancy

Intervention

Behavioral:
• Rosie the Chatbot
Participants in the intervention group will be using the chatbot to ask questions related to the mom and baby's health, provide feedback "selecting thumbs up or thumbs down" on the questions' response, and use the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus). In addition, participants will be taking a pre-test health survey, mid-test health survey, and post-test health survey.

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mane HY, Channell Doig A, Marin Gutierrez FX, Jasczynski M, Yue X, Srikanth NP, Mane S, Sun A, Moats RA, Patel P, He X, Boyd-Graber JL, Aparicio EM, Nguyen QC. Practical Guidance for the Development of Rosie, a Health Education Question-and-Answer Chatbot for New Mothers. J Public Health Manag Pract. 2023 Sep-Oct 01;29(5):663-670. doi: 10.1097/PHH.0000000000001781. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal postpartum depression	The investigators will utilize the Patient Health Questionnaire (PHQ-9) Scale to measure maternal depression. This scale can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate worse depression severity.	12 months post randomization
Primary	Number of emergency room visits	The investigators will measure the number of visits to the emergency room.	12 months post randomization
Primary	Attendance of well-baby visits (preventive healthcare visits)	The investigators will measure the number of well-baby visits.	12 months post randomization

External Links

•   Rosie aims to help close the racial gap in maternal and infant health disparities by providing new mothers with easy access to reliable health information.