Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women

NCT05876559 | Completed

• 2 other identifiers: p-20167R44MD014923
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Health

Outcome Measures

Primary Outcomes (1)

• Barkin Index of Maternal Functioning (BIMF)

  The BIMF is a 20-item self-report measure designed to assess overall functioning in the context of new motherhood. Functional domains include social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). The BIMF demonstrates strong internal consistency. with Cronbach's alpha for the full 20-item scale between .83-.87 indicating strong inter-item agreement. A total score is generated from summing the 20 items (after the reverse-coding of items 16 and 18) and ranges from 0 to 120. Higher total scores are associated with greater levels of functioning.

  Change between baseline and 12 months

Secondary Outcomes (3)

• Edinburgh Postnatal Depression Scale (EPDS)

  Change between baseline and 12 months

• State-Trait Anxiety Inventory (STAI)

  Change between baseline and 12 months

• Connor-Davidson Resilience Scale (CDRS)

  Change between baseline and 12 months

Other Outcomes (2)

• COVID-19 and Mental Health Impacts Scale

  Change between baseline and 12 months

• Maternal Health Knowledge

  Change between baseline and 12 months

Study Arms (2)

active intervention group

EXPERIMENTAL

Participants will receive immediate access to Joyuus selfcare mobile app

Other: Joyuus Self-care Mobile App

standard care control group

ACTIVE COMPARATOR

Participants will receive standard care, and will not have access to Joyuus selfcare mobile app until study completion.

Other: Standard Care

Interventions

Joyuus Self-care Mobile App OTHER

Joyuus is an innovative self-care mobile tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes. It provides the appropriate information, knowledge, and skills to improve postpartum health through self-care, and identifies when it is appropriate to seek care.

active intervention group

Standard Care OTHER

Standard care is access to typical resources women have access to during postpartum and does not include the Joyuus intervention.

standard care control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: The study is about postpartum health for mothers who have given birth. The study does not distinguish on gender identity but focuses on birthing people.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Joyuus, LLC: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Lisa Marceau

Westerly, Rhode Island, 02817, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigators plan to conduct a 3-month, parallel-group, randomized controlled trial (RCT) to evaluate the effectiveness on improving maternal functioning.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: January 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)