Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women

NCT04475718 | Completed Results

• 1 other identifier: R43MD014923
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

The postpartum period is a critical time for both maternal and child health, and more than half of all maternal deaths occur postpartum, from one day to one year after birth. This poor outcome is linked to the racial and ethnic disparities that disproportionately effects low income and black women. To reduce the burden of the postpartum period for this population, the goal of this project is to develop an accessible, targeted online tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes by providing the appropriate tools, knowledge and skills to improve postpartum health.

Conditions

Pregnancy Related; Postpartum Sadness

Keywords

Postpartum health; Fourth trimester; Resiliency; Health disparities; Maternal health; Mobile tools; Human-centered design; Digital health

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Resilience at 4 Weeks

  Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.

  baseline, 4 weeks

Secondary Outcomes (4)

• Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)

  baseline, 4 weeks

• Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey

  baseline, 4 weeks

• Change From Baseline Parent Anxiety at 4 Weeks

  baseline, 4 weeks

• Change From COVID-19 and Mental Health Impacts at 4 Weeks

  baseline, 4 weeks

Study Arms (1)

Fourth Trimester Mobile Tool

OTHER

Fourth Trimester Mobile Tool

Behavioral: Fourth Trimester Mobile Tool

Interventions

Fourth Trimester Mobile Tool BEHAVIORAL

A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.

Fourth Trimester Mobile Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+;
• Self-reported annual household income less than $39,500 (at least 75% of participants - defined as "low income" household by the PEW Research Center);
• Racial/ethnic minority (at least 75% of participants must be non-white, with at least 50% identifying as Black/African American);
• Be a new or expectant mother - participants must be at least 28 weeks/6 months pregnant (3rd trimester), and up to 6 months post-birth (no more than 10% of participants will be currently pregnant, at least 90% will be postpartum).
• Able to comply with the terms of the study (available time commitment, have internet access; willing to comply with the specified focus groups and survey); and
• Able to read, write and speak English (all research and product development activities will be conducted in English due to budgetary constraints).

You may not qualify if:

• Did not have a live birth (for those who are post-birth)
• Self-reported major medical/health issue which would impact participants' health or ability to participate.

Sponsors & Collaborators

• Carelon Research: lead
• Orange Square Design, Inc.: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

HealthCore

Watertown, Massachusetts, 02472, United States

Location

Orange Square Design Inc.

Pawtucket, Rhode Island, 02860, United States

Location

Results Point of Contact

• Title: Lisa Marceau
• Organization: Orange Square Designs

lisa@orangesquare.com

4014284197

Study Officials

• Kristine Merz

  Orange Square Design, Inc.

  PRINCIPAL INVESTIGATOR

• Lisa Marceau, MPH

  Carelon Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Vice President, Digital Research Solutions

Model Details: Interviews were conducted with 24 pregnant and postpartum women. From this research and other activities, the investigators built a prototype program. Once the prototype was completed, the investigators conducted a clinical trial with 87 participants. The pre-test captured key outcome measures (resilience, stress, anxiety, depression, fear, knowledge, and variables related to COVID-19) and other descriptive variables. All participants who completed the pre-test were given access to the prototype mobile postpartum tool. Participants were asked to actively engage with the tool for 4 weeks, during which time they provided real-time user experience feedback. At the end of the 4-week period, the investigators conducted a post-test to measure change in outcomes.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: May 17, 2021
• Primary Completion: July 29, 2021
• Study Completion: December 31, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)