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Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

Primary Purpose

Pregnancy, Postpartum Depression, Infant Development

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rosie the Chatbot
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy focused on measuring chatbot, health information, racial/ethnic health disparities, maternal and child health, artificial intelligence, question-answering models

Eligibility Criteria

14 Years - 99 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Rosie the Chatbot Group

    Book Club Group

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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.
    Number of emergency room visits
    The investigators will measure the number of visits to the emergency room.
    Attendance of well-baby visits (preventive healthcare visits)
    The investigators will measure the number of well-baby visits.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University of Maryland, College Park
    Collaborators
    National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06053515
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 9, 2023 (Anticipated)
    Primary Completion Date
    May 20, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Maryland, College Park
    Collaborators
    National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy, Postpartum Depression, Infant Development, Infant Conditions
    Keywords
    chatbot, health information, racial/ethnic health disparities, maternal and child health, artificial intelligence, question-answering models

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rosie the Chatbot Group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Book Club Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Rosie the Chatbot
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Maternal postpartum depression
    Description
    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.
    Time Frame
    12 months post randomization
    Title
    Number of emergency room visits
    Description
    The investigators will measure the number of visits to the emergency room.
    Time Frame
    12 months post randomization
    Title
    Attendance of well-baby visits (preventive healthcare visits)
    Description
    The investigators will measure the number of well-baby visits.
    Time Frame
    12 months post randomization

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female at birth
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quynh C Nguyen, PhD
    Phone
    3014056425
    Email
    qtnguyen@umd.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth M Aparicio, PhD, LCSW-C
    Phone
    3014052029
    Email
    aparicio@umd.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quynh C Nguyen, PhD
    Organizational Affiliation
    University of Maryland
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elizabeth M Aparicio, PhD, LCSW-C
    Organizational Affiliation
    University of Maryland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    37478093
    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.
    Results Reference
    background
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10372746/
    Description
    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.

    Learn more about this trial

    Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

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