Clinical trial NCT04475718: Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women
Official title: Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Postpartum Sadness
Keywords: Postpartum health
Fourth trimester
Resiliency
Health disparities
Maternal health
Mobile tools
Human-centered design
Digital health
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: Orange Square Design, Inc.
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-07-17
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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).

Exclusion Criteria:

* Unable to comply with the Inclusion Criteria
* 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.

Primary outcomes:
measure: Change From Baseline Resilience at 4 Weeks
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: baseline, 4 weeks
measure: Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey
timeFrame: baseline, 4 weeks
measure: Change From Baseline Parent Anxiety at 4 Weeks
timeFrame: baseline, 4 weeks
measure: Change From COVID-19 and Mental Health Impacts at 4 Weeks
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Watertown
country: United States
facility: HealthCore
state: Massachusetts
city: Pawtucket
country: United States
facility: Orange Square Design Inc.
state: Rhode Island
Study officials:
affiliation: Orange Square Design, Inc.
name: Kristine Merz
role: PRINCIPAL_INVESTIGATOR
affiliation: Carelon Research
name: Lisa Marceau, MPH
role: PRINCIPAL_INVESTIGATOR
References: