Clinical trial NCT05595486: Baby2Home (B2H) Mobile Health Application
Official title: Baby2Home (B2H) Mobile Health Application: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19 Pandemic
Health Knowledge, Attitudes, Practice
Perinatal Depression
Mental Health Wellness
Post Partum Depression
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Northwestern University
First posted: 2022-10-27
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families will be randomized into either the control or intervention group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The COVID-19 pandemic has transformed healthcare delivery; arguably, the fields of obstetrics and pediatrics have experienced some of the greatest changes as they have transitioned away from their role as a medical home and into more of an urgent care model of care. Baby2Home is a digital health intervention designed to bridge the resultant gaps in obstetrics and pediatrics healthcare services for new families over the first year of life. This randomized controlled trial will evaluate whether, compared to usual care, Baby2Home 1) improves maternal, paternal, and infant health service utilization outcomes over the first year postpartum, 2) improves maternal and paternal patient reported outcomes, and 3) reduces racial/ethnic and income-based disparities in preventive health services utilization and parental patient reported outcomes.

Detailed description: The transition to new parenthood is marked by dramatic changes in social roles and responsibilities. To support new parents, obstetric and pediatric healthcare surrounding this transition is designed with a supportive focus to facilitate new parents' navigation of the attendant life changes. The COVID-19 pandemic has altered healthcare delivery in ways that have limited these supportive obstetrics and pediatric services provided at the beginning of new parenthood. Consequently, aspects of preventative healthcare, such as monitoring for symptoms of postpartum depression, discussing optimal birth control options, educating parents on recommended adult and pediatric vaccinations, and providing anticipatory guidance on infant wellness, are less robust. In addition, without professional guidance and support, outcomes of foundational importance to new parents, such as perceived stress, depressive and anxiety symptoms, or parenting and breast-feeding self-efficacy, are worse. Moreover, the COVID-19 pandemic has underscored the impact of the social determinants of health on new family wellness, with racial/ethnic minority and low-income families being differentially impacted by COVID-19 pandemic driven healthcare delivery changes. Recognizing the potential for longitudinal changes in healthcare delivery engendered by the COVID-19 pandemic, a scalable, patient-centered, equity-focused intervention designed to bridge gaps in healthcare services around the transition to new parenthood is needed.

"Bridging gaps in healthcare delivery to COVID-19 for parent and infants from birth through the first year of life" aims to evaluate Baby2Home (B2H) a patient-informed digital healthcare intervention that s is specifically responsive to the COVID-19 pandemic's impact on new families, with a focus on health equity for racial/ethnic minority and low-income families. B2H builds upon previous digital health successes while incorporating the evidence-based collaborative care model for mental health support. B2H is designed to mitigate the adverse effects of healthcare delivery changes in response to the COVID-19 pandemic and to improve health for mothers, fathers, and infants over the first year of life. Developed from feedback given by new parents who delivered during the COVID-19 pandemic, B2H provides 1) parental education about their own physical and mental health, 2) infant wellness resources and tracking of recommended healthcare services, 3) parental mental health screening and support, and 4) systematic case review to optimize the health of new families. The investigators will test the efficacy of B2H via a randomized control trial. In total, 640 diverse families will be randomly to either usual care or B2H intervention arm to evaluate whether, compared to usual care, B2H health services utilization and patient reported outcomes of foundational important to new families. addition, the investigators will evaluate the impact of B2H on racial/ethnic and income-based disparities observed in both services utilization and patient reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Delivery at Prentice Women's Hospital or Women and Infants Hospital of Rhode Island
* Viable term infant (≥ 37 weeks)
* First live born child
* English speaking
* Age 18 years old or greater
* Access to a smartphone
* Access to a working email address

Exclusion Criteria:

* No smartphone access
* Infant death
* Infant requires NICU admission
* Known severe mental illness of either parent (e.g., bipolar disorder, schizophrenia)
* SARS-CoV-2 infection without clinical clearance
* History of IPV (intimate partner violence) with current partner (would exclude partner)
* Concurrent enrollment in studies that may affect the outcome of the trial (or vice versa)

Primary outcomes:
measure: Completion of preventive health services utilization for all family members (birthing, non-birthing, and infant)
timeFrame: Baseline through 1 year postpartum
Secondary outcomes:
measure: Number of participants who attend comprehensive postpartum visit (birthing parent)
timeFrame: At least once between 4 and 12 weeks postpartum
measure: Completion of postpartum depression screening (birthing parent)
timeFrame: Through study completion, up to 12 months
measure: Number of participants who received contraception (birthing and non-birthing parent)
timeFrame: Through study completion, up to 12 months
measure: Number of participants who received the recommended vaccinations (non-birthing parent)
timeFrame: Through study completion, up to 12 months
measure: Completion of postnatal depression screening for non-birthing parent
timeFrame: Through study completion, up to 12 months
measure: Number of participants who attended well-child visits for the infant
timeFrame: Through study completion, up to 12 months
measure: Number of participants who received the recommended vaccinations for infant
timeFrame: Through study completion, up to 12 months
measure: Continued breastfeeding for infants until 6 months
timeFrame: Through study completion, up to 6 months
measure: Duration of breastfeeding (birthing parent)
timeFrame: Through study completion, up to 6 months
measure: Patient reported outcomes: stress symptoms (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: depressive symptoms (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: anxiety symptoms (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: global health status (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: relationship assessment (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: self-efficacy (for birthing and non-birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
measure: Patient reported outcomes: parenting self-efficacy (for birthing and non-birthing parent)
timeFrame: Month 12
measure: Patient reported outcomes: breastfeeding self-efficacy (for birthing parent)
timeFrame: Month 1, 2, 4, 6, and 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Prentice Women's Hospital
state: Illinois
city: Providence
country: United States
facility: Women and Infant's Hospital
state: Rhode Island
Study officials:
affiliation: Lurie Children's Hospital
name: Craig Craig, MD
role: STUDY_DIRECTOR
References: