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

• Sponsor: University of Maryland, College Park (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06053515
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 400
• Arms: 2
• Anticipated Duration (Months): 32.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Racial or Ethnic Minority Women	Behavioral: Rosie the Chatbot	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication to Reduce Disparities in Maternal and Child Health
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: May 20, 2025
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosie the Chatbot 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 using the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).	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.
No Intervention: Book Club Group 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.

Outcome Measures

Primary Outcome Measures

1. Maternal postpartum depression [12 months post randomization]

   We will utilize the Edinburgh Postnatal Depression Scale to measure maternal depression

2. Number of emergency room visits [12 months post randomization]

   Total number of visits to the emergency room

3. Attendance of well-baby visits [12 months post randomization]

   Total number of well-baby visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 14 years and older.

• Racial/ethnic 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Quynh C Nguyen, PhD, University of Maryland
• Principal Investigator: Elizabeth M Aparicio, PhD, MSW, LCSW-C, University of Maryland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

• 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.

• Responsible Party: University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT06053515
• Other Study ID Numbers: 5R01MD016037-03
• First Posted: Sep 25, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 25, 2023