Clinical trial NCT05876559: Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women
Official title: Joyuus: A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Health
Lead sponsor: Joyuus, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-25
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators plan to conduct a 3-month, parallel-group, randomized controlled trial (RCT) to evaluate the effectiveness on improving maternal functioning.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this RCT is to evaluate the effectiveness of Joyuus on improving maternal functioning with postpartum moms. The main questions it aims to answer are:

* The primary hypothesis is that participants of the Joyuus program will demonstrate improved functional status compared to the control arm participants at 3-month follow-up.
* The secondary hypotheses are that participants using the Joyuus tool will demonstrate improvement in depression, anxiety, resilience, social support, and knowledge compared to the control arm at 6- and 12-weeks follow-up.

Detailed description: In the United States, the postpartum period is a critical time for both maternal and child health; the US maternal mortality rate is the highest among other developed, high-income countries. More than half of all maternal deaths occur postpartum, from one day to one year after birth. There are vast racial and ethnic disparities in maternal mortality and severe morbidity, disproportionately experienced by Black and Latina mothers and other BIPOC women. Black women are 3-4 times more likely to experience maternal mortality than white women10, and Hispanic women are twice as likely to experience severe maternal outcomes compared with non-Hispanic white women. The American College of Obstetricians and Gynecologists recognized the deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time following birth through the first 3-months postpartum. They recently updated recommendations to address these challenges. The Biden Build Back Better Act also prioritized this issue. Joyuus is a web-based self-care mobile tool addressing the 12 months postpartum, to reduce the risks of avoidable morbidity and mortality for underserved women. The tool addresses physical, mental, real world, cultural, and knowledge barriers which impact quality postpartum care. Joyuus provides information, resources, expert perspectives, peer communications and red flags presented in a variety of formats to help women identify how to adopt healthy self-care habits. Importantly, it also identifies when self-care leads to seeking provider care. Pregnant women often turn to the internet to find information about their health and their developing baby's health. Yet, studies find that mothers are not finding sufficient resources to match their postpartum needs. The Phase I grant demonstrated in a sample of Black women that this audience is highly engaged across the income and education spectrum and prefers mobile access and text-based communication. In Phase II work will continue to include lived experiences of women most at risk for negative postpartum outcomes as part of the complete tool. The first step will be to conduct a needs assessment to understand informational, cultural and language wants and needs in the Latina population. The broader randomized trial will invite a diverse population of BIPOC and white women. The Phase II scope aims to complete three major tasks:

AIM 1: Expand feasibility activities to address Latina population. Explore self-care (and seeking care) needs for the postpartum Latina community and integrate with the Phase I focus group findings.

AIM 2: Build complete tool. The investigators will complete the development of a fully interactive Joyuus web based mobile tool in English and Spanish.

AIM 3: Test in randomized controlled trial. The investigators will test the effectiveness of Joyuus with a diverse national sample of postpartum women, considering the impact on maternal function, depression, anxiety, resilience, knowledge, and social support.

Eligibility criteria: Inclusion Criteria:

* Must be age 18 or older
* Must be between 0-6 months postpartum
* Must have a smartphone with internet access and are willing to use this device to participate in all study activities; and
* Must be able to speak, read, and write in English

Exclusion Criteria:

* Medical/health issues which would impact participants' health or ability to participate
* Did not have a live birth

Primary outcomes:
measure: Barkin Index of Maternal Functioning (BIMF)
timeFrame: Change between baseline and 12 months
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Change between baseline and 12 months
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change between baseline and 12 months
measure: Connor-Davidson Resilience Scale (CDRS)
timeFrame: Change between baseline and 12 months
Other outcomes:
measure: COVID-19 and Mental Health Impacts Scale
timeFrame: Change between baseline and 12 months
measure: Maternal Health Knowledge
timeFrame: Change between baseline and 12 months
Locations:
city: Westerly
country: United States
facility: Lisa Marceau
state: Rhode Island
Study officials:
References: