What side effects are associated with this type of intervention?

Digital health interventions, such as the Baby2Home app, generally have minimal physical side effects. However, users may experience digital fatigue, frustration with technology, or privacy concerns. Additionally, there can be variability in user engagement and adherence, which may impact the effectiveness of the intervention. It is important for users to have access to technical support and clear instructions to mitigate these issues.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of health literacy as it is primarily an educational and behavioral issue. However, digital health interventions like Baby2Home, which aim to improve health service utilization and patient outcomes, are increasingly being studied and implemented. These interventions often focus on providing accessible health information, reminders for medical appointments, and support for managing health conditions, thereby indirectly improving health literacy.

What other types of research exist?

Promising alternatives to Baby2Home for health literacy patients in 2024 include: 1) Text4baby, which provides educational text messages to pregnant and postpartum women, focusing on underserved populations. 2) Mobile health apps for smoking cessation, such as Smokefree Teen, which offer tailored support and educational resources. 3) Digital platforms like the National Cancer Institute's Smokefree.gov, which provide comprehensive health information and support through various digital channels.

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Behavioural Intervention

Baby2Home Mobile Application for Mental Health Wellness

N/A

Waitlist Available

Research Sponsored by Women and Infants Hospital of Rhode Island

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years old or greater

Viable term infant (≥ 37 weeks)

Must not have

Infant requires NICU admission

SARS-CoV-2 infection without clinical clearance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 1 year postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Baby2Home, a digital program to help new parents and their babies. It aims to improve health outcomes and reduce disparities for families affected by COVID-19. The program provides education, wellness tracking, mental health support, and regular check-ins.

Who is the study for?

This trial is for new parents with a healthy, full-term baby (≥37 weeks) born at specific hospitals. Participants must be over 18, speak English, have smartphone access and an email address. It's not for those whose infant passed away or needs NICU care, have severe mental illness, are in certain other studies, experienced IPV with the current partner or lack clinical clearance post-COVID-19 infection.

What is being tested?

The Baby2Home Mobile Application is being tested to see if it can improve healthcare service use and parental outcomes during the first year after birth compared to usual care. The study also looks at whether it reduces health disparities based on race/ethnicity and income.

What are the potential side effects?

Since this trial involves a mobile application rather than medication or medical procedures, traditional side effects are not applicable. However, users may experience issues related to app usability or increased screen time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My baby was born at or after 37 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant needs to be admitted to the NICU.

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I currently have a COVID-19 infection without recovery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 1 year postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 1 year postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 1 year postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)

Secondary study objectives

Anxiety symptoms (for birthing and non-birthing parent)

Breastfeeding self-efficacy (for birthing parent)

COVID-19 related impact (for birthing and non-birthing parent)

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Baby2Home InterventionExperimental Treatment1 Intervention

Families randomized to the intervention arm will receive the B2H services. B2H is a novel digitized CC-based intervention delivered via a smartphone app available on iOS or Android phones, built by combining two successful programs: NICU2Home+ app and CC services. Using the UCD methodologies, AI-based communication within the app will include education for mothers and fathers on the standard of care regarding self-care and newborn care after hospital discharge as well as education, reminders and scheduling for recommended preventative healthcare services for themselves and their new infant.

Group II: Usual CareActive Control1 Intervention

As a pragmatic trial, usual care will be defined by contemporary clinical standards. For maternal care, this includes a comprehensive medical visit between 4-12 weeks postpartum. This visit includes utilization of a validated screen for postpartum depression and, if that screen is positive, a clinical assessment and initiation of treatment (e.g. pharmacotherapy or referral for psychotherapy). In addition, this visit includes a discussion of contraception as well as supportive education on breastfeeding. For paternal care, clinical standards are gleaned from the AAP, ACOG, and USPSTF reports outlining mental health screening, reproductive health, and vaccine uptake. For infant care, standard pediatric care from the AAP and Bright Futures periodicity timeline and guidelines will be used. In addition, assignment in this arm will be given surveys at baseline, 1M, 2M, 4M, 6M, and 12M.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Digital health interventions like Baby2Home improve health literacy by providing accessible, user-friendly information and resources through mobile applications. These tools often include educational content, reminders for medical appointments, and personalized health tracking, which empower patients to manage their health more effectively. For patients with low health literacy, such interventions are crucial as they simplify complex medical information, promote adherence to health recommendations, and facilitate timely utilization of healthcare services, ultimately leading to better health outcomes.

Mapping Digital Public Health Interventions Among Existing Digital Technologies and Internet-Based Interventions to Maintain and Improve Population Health in Practice: Protocol for a Scoping Review.A systematic review of person-centered care interventions to improve quality of facility-based delivery.The Cochrane Library review titles that are important to users of health care, a Cochrane Consumer Network project.