Rosie Chatbot Assistance for Pregnancy and Infant Care

Overseen By Elizabeth M Aparicio, PhD, MSW, LCSW-C

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Disqualifiers: Non-hispanic white, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a chatbot named Rosie, designed to assist mothers with questions about pregnancy and infant care. Rosie provides instant information from trusted sources on topics such as health and infant milestones, in both English and Spanish. Participants will either use Rosie the Chatbot or join a book club group and will complete surveys to assess the chatbot's usefulness. This trial is ideal for racial minority women who are pregnant or have an infant under 6 months and can read English or Spanish. As an unphased trial, participants contribute to pioneering research that may enhance support for new mothers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a chatbot for educational purposes, so it's unlikely that medication changes are required.

What prior data suggests that Rosie the Chatbot is safe for use in pregnancy and infant care?

In a previous study, researchers created Rosie the Chatbot to provide new mothers with reliable health information. This information assists with issues during pregnancy and after childbirth. Research has shown that Rosie does not collect personal information, ensuring privacy. The chatbot uses information from trusted organizations, guaranteeing safe and accurate advice.

As an app that provides information, Rosie causes no physical side effects. It functions like a digital assistant that answers health questions. To date, no negative effects have been reported from using Rosie, making it a well-tolerated tool for mothers seeking guidance on pregnancy and infant care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Rosie the Chatbot because it offers a new way to support pregnancy and infant care by providing instant, accessible information through a digital platform. Unlike traditional methods that rely on in-person consultations or static resources, Rosie is interactive, allowing users to ask questions and receive tailored advice anytime. The chatbot also includes features like a video library and a daily syllabus, providing a comprehensive, easy-to-use resource that could significantly enhance maternal and infant health education.

What evidence suggests that Rosie the Chatbot is effective for pregnancy and infant care?

Studies have shown that Rosie the Chatbot, used by participants in the Rosie the Chatbot Group of this trial, can enhance understanding of health information for pregnant women, particularly among minority groups. One study found that women using Rosie increased their health knowledge by 19%. Most participants used Rosie regularly, with some engaging daily and others weekly. The chatbot provides quick answers to questions about pregnancy and baby care, drawing information from trusted sources like children's hospitals and health organizations. This indicates that Rosie is a valuable tool for obtaining reliable health information during pregnancy and early parenting. ^{2 6 7 8 9}

Who Is on the Research Team?

Quynh C Nguyen, PhD

Principal Investigator

University of Maryland

Elizabeth M Aparicio, PhD, LCSW-C

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for moms or pregnant women who are at least 14 years old, belong to racial/ethnic minority groups, and can read English or Spanish. It's designed for those with an infant under 6 months old or who are currently expecting.

Inclusion Criteria

I am 14 years old or older.

You possess fluency in either English or Spanish.

I am currently pregnant or have a baby under 6 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the Rosie the Chatbot group or the Book Club group. The Rosie group uses the chatbot app, while the Book Club group receives monthly children's books.

12 months

Pre-test, mid-test, and post-test health surveys

Follow-up

Participants are monitored for maternal and infant health outcomes, including well-baby visits, maternal postpartum depression, and emergency room visits.

12 months post randomization

What Are the Treatments Tested in This Trial?

Interventions

• Rosie the Chatbot

Trial Overview The trial is testing 'Rosie the Chatbot,' a digital assistant that provides immediate health-related information about pregnancy and infant care from verified sources in both English and Spanish without requiring personal data.

How Is the Trial Designed?

Group I: Rosie the Chatbot Group Experimental Treatment 1 Intervention

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).

Group II: Book Club Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The development of the Parentbot mobile application for parenting support was guided by user-centered design principles, resulting in a prototype that meets the needs of multi-racial Singaporean parents during the perinatal period.

User acceptability testing with 11 participants showed a positive user experience, indicating that the app is well-received, although its effectiveness in improving parental outcomes is still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Parentbot - A Digital healthcare Assistant (PDA)': A mobile application-based perinatal intervention for parents: Development study. Chua, JYX., Choolani, M., Chee, CYI., et al.[2023]

In a study with 32 participants, those who received a correct paraphrase of their medical query from conversational assistants were more likely to follow the advice given, highlighting the importance of accurate information delivery.

Participants who received a disclaimer message were significantly more inclined to consult a physician before acting on the advice, suggesting that incorporating disclaimers can help mitigate the risks of harmful medical recommendations from conversational assistants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating Patient and Consumer Safety Risks When Using Conversational Assistants for Medical Information: Exploratory Mixed Methods Experiment. Bickmore, TW., Ólafsson, S., O'Leary, TK.[2022]

A review of 78 health-focused apps with chatbots (healthbots) revealed that most are designed for patient use, primarily focusing on primary care and mental health, but only a small percentage comply with health information privacy regulations.

Despite the potential of healthbots to improve healthcare access, most apps rely on simple algorithms for interaction rather than advanced natural language processing or machine learning, indicating a need for further development to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-focused conversational agents in person-centered care: a review of apps. Parmar, P., Ryu, J., Pandya, S., et al.[2022]

A study involving 54 participants found that 29% of the actions suggested by conversational assistants for medical problems could potentially lead to patient harm, with 16% of those actions posing a risk of death.

Only 43% of the medical queries were successfully completed, highlighting the unreliability of conversational assistants for providing safe and actionable medical information, emphasizing the need for users to consult healthcare providers for medical advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Consumer Safety Risks When Using Conversational Assistants for Medical Information: An Observational Study of Siri, Alexa, and Google Assistant. Bickmore, TW., Trinh, H., Olafsson, S., et al.[2019]

Parents and parents-to-be found chatbots to be a valuable resource for receiving informational, socioemotional, and psychological support during preconception, pregnancy, and postpartum periods, as highlighted in a review of 15 studies.

Despite their benefits, users identified obstacles to effective use, suggesting the need for improvements in chatbot functionality and training for healthcare providers to enhance the integration of this digital health technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights of Parents and Parents-To-Be in Using Chatbots to Improve Their Preconception, Pregnancy, and Postpartum Health: A Mixed Studies Review. Chua, JYX., Choolani, M., Chee, CYI., et al.[2023]

A focus group study involving 12 women with previous cesareans and 8 prenatal providers evaluated an Embodied Conversational Agent (ECA) designed to assist in decision-making about birth options, revealing that both groups found the ECA could effectively provide information and support during consultations.

Participants noted that while the ECA appeared somewhat 'robot-like,' improvements in its visual appeal and clarity regarding its role in the decision-making process are necessary for better integration into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perspectives of Women and Their Health-Care Providers Regarding Using an ECA to Support Mode of Birth Decisions. Chinkam, S., Steer-Massaro, C., Herbey, I., et al.[2022]

The online preconception conversational agent 'Gabby' significantly reduced the number and proportion of preconception health risks among 100 African American women, with the Gabby group showing an average reduction of 8.3 risks compared to 5.5 in the control group over six months.

Participants in the Gabby group found the system easy to use, with 64% reporting they used the information to improve their health, indicating that Gabby may be an effective tool for addressing health disparities in preconception care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Preconception Risks Among African American Women with Conversational Agent Technology. Jack, B., Bickmore, T., Hempstead, M., et al.[2022]

The chatbot Rosie is being developed to provide accessible and reliable health information to pregnant women and new mothers of color, addressing the higher maternal and infant mortality rates in these communities.

During demonstrations with 109 participants, 90% expressed a likelihood to use Rosie, indicating a strong demand for resources that support maternal and infant health, particularly in areas like baby development and nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Guidance for the Development of Rosie, a Health Education Question-and-Answer Chatbot for New Mothers. Mane, HY., Channell Doig, A., Marin Gutierrez, FX., et al.[2023]

The study highlights the potential of chatbots as effective digital health tools for improving self-care among pregnant women, which is crucial for managing health outcomes during pregnancy.

A systematic literature review revealed limited existing research on user experiences with chatbots in this context, indicating a need for further exploration and development of such technologies in primary health care services in Brazil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GISSA intelligent chatbot experience - How effective was the interaction between pregnant women and a chatbot during the COVID-19 pandemic? Silveira, R., Pernencar, C., de Sousa, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10372746/

Practical Guidance for the Development of Rosie, a Health ... A chat window page allows users to ask Rosie any questions related to pregnancy, postpartum health, infant health, and infant care. In addition, ...

2. formative.jmir.org formative.jmir.org/2024/1/e51361

Rosie, a Health Education Question-and-Answer Chatbot for ... Rosie, a question-and-answer chatbot, was developed as a mobile app and is available to answer questions about pregnancy, parenting, and child development.

3. researchgate.net researchgate.net/publication/375902237_Randomized_Pilot_of_Rosie_a_Health_Education_Question-and-Answer_Chatbot_for_New_Mothers_Preprint

Randomized Pilot of Rosie, a Health Education Question ... The "Rosie" chatbot in the United States improved maternal health literacy among minority women [22] . And a study in Iran also reported a 19% increase in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38214963/

Rosie, a Health Education Question-and-Answer Chatbot for ... More than 87% (13/15) of Rosie treatment group members reported using Rosie daily (5/15, 33%) or weekly (8/15, 53%) across the 3-month study ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06053515/rosie-the-chatbot-leveraging-automated-and-personalized-health-information-communication

Rosie the Chatbot: Leveraging Automated and ... 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10818229/

Rosie, a Health Education Question-and-Answer Chatbot ... Rosie, a question-and-answer chatbot, was developed as a mobile app and is available to answer questions about pregnancy, parenting, and child development.

7. jphmpdirect.com jphmpdirect.com/building-and-demoing-rosie-the-chatbot-in-the-community/

Building and Demoing Rosie the Chatbot in the Community Rosie aims to help close the racial gap in maternal and infant health disparities by providing new mothers with easy access to reliable health ...

8. researchgate.net researchgate.net/publication/372570821_Practical_Guidance_for_the_Development_of_Rosie_a_Health_Education_Question-and-Answer_Chatbot_for_New_Mothers

Practical Guidance for the Development of Rosie, a Health ... ... Rosie aims to provide reliable health information to new mothers, helping them address various issues during pregnancy and postpartum.

9. pediatrics.jmir.org pediatrics.jmir.org/2024/1/e56807/

Development and Refinement of a Chatbot for Birthing ... Results: Overall, 2748 (63%) individuals opened the newborn chatbot messaging, and 2244 (64%) individuals opened the postpartum chatbot ...