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

NCT ID: NCT04475718

Last Updated: 2023-02-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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In the United States, the postpartum period is a critical time for both maternal and child health, the mortality rate is the highest among other developed, high income countries 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 effect black women who are 3-4 times more likely to experience maternal mortality than white women. Recently, 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 the birth of the infant through the first 3-months postpartum, and updated its recommendations to address these challenges. With impacts to health outcomes and healthcare costs, there is a need to holistically bridge the gap for low-income and/or ethnically diverse groups of women to address the physical, cultural, and knowledge barriers to accessing quality postpartum care.

To improve the rate at which underserved women are disproportionately affected by maternal mortality and morbidity, the investigators need to engage women leading into and specifically during the postpartum period to identity areas of need, and to provide tools which reduce barriers for women to get appropriate postpartum care. Technology offers innovative solutions to challenges around equal information access. Pregnant women often turn to the internet to find out more information about their health and their developing babies health. Yet, studies find that mothers are not finding sufficient resources to match their postpartum needs.

To address this gap in care, this project aims to develop a mobile tool designed to increase accessibility to information and practical approaches for addressing the complex needs of women in this 'fourth trimester'. This tool will specifically focus on underserved women who are at greatest risk of adverse postpartum outcomes.

Conditions

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Pregnancy Related Postpartum Sadness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Fourth Trimester Mobile Tool

Fourth Trimester Mobile Tool

Group Type OTHER

Fourth Trimester Mobile Tool

Intervention Type 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.

Interventions

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Fourth Trimester Mobile Tool

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Orange Square Design, Inc.

INDUSTRY

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Carelon Research

OTHER

Sponsor Role lead

Responsible Party

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Lisa Marceau

Staff Vice President, Digital Research Solutions

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Merz

Role: PRINCIPAL_INVESTIGATOR

Orange Square Design, Inc.

Lisa Marceau, MPH

Role: PRINCIPAL_INVESTIGATOR

Carelon Research

Locations

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HealthCore

Watertown, Massachusetts, United States

Site Status

Orange Square Design Inc.

Pawtucket, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R43MD014923

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R43MD014923

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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