Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876559
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-05-16
Brief Title:
Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women
Sponsor:
Joyuus LLC
Organization:
Joyuus LLC
Study Overview
Official Title:
Joyuus A Web-based Tool for Postpartum Care Self-care to Address the Complex Needs of Underserved Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 babys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44MD014923 | NIH | None | httpsreporternihgovquickSearchR44MD014923 |