Clinical trial NCT06053515: Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication
Official title: Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication to Reduce Disparities in Maternal and Child Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Postpartum Depression
Infant Development
Infant Conditions
Keywords: chatbot
health information
racial/ethnic health disparities
maternal and child health
artificial intelligence
question-answering models
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal postpartum depression
timeFrame: 12 months post randomization
measure: Number of emergency room visits
timeFrame: 12 months post randomization
measure: Attendance of well-baby visits (preventive healthcare visits)
timeFrame: 12 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Quynh C Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Elizabeth M Aparicio, PhD, LCSW-C
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.