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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475718
• Other study ID #: R43MD014923
• Secondary ID: R43MD014923
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: HealthCore-NERI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 31, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Sadness
• Pregnancy Related

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Orange Square Design Inc.	Pawtucket	Rhode Island
United States	HealthCore	Watertown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
HealthCore-NERI	National Institute on Minority Health and Health Disparities (NIMHD), Orange Square Design, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS)	The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.	baseline, 4 weeks
Secondary	Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey	The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.	baseline, 4 weeks
Secondary	Change From Baseline Parent Anxiety at 4 Weeks	The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.	baseline, 4 weeks
Secondary	Change From COVID-19 and Mental Health Impacts at 4 Weeks	The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.	baseline, 4 weeks