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NOT YET RECRUITING
NCT06744231
NA

Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

The overarching goal of Thriving Hearts is to implement a multi-level program through Local Health Departments (LHDs) that cultivates conditions for mothers and birthing people to not only survive pregnancy, but to thrive. Thriving Hearts is a collaboration among LHDs in ten North Carolina counties, designed to reduce incidence of Hypertensive Disorders of Pregnancy (HDP) and their complications through support and connection at the individual, healthcare provider, and community level. The investigators will conduct a pragmatic, stepped-wedge, cluster randomized study. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in clusters in a randomly assigned sequence at 9-month intervals.

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17500

Start Date

2025-04-01

Completion Date

2029-12

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

OTHER

Usual Care

Prior to implementation of the Thriving Hearts package of services, people living in participating counties will receive usual care for pregnancy, birth, and postpartum services. The study team will quantify existing services using a study-developed usual care assessment instrument.

BEHAVIORAL

Thriving Hearts

Thriving Hearts is a collaboration among LHDs in ten North Carolina counties. At the individual level, pregnant individuals will self-screen for HDP risk during prenatal visits, and those at risk will be provided a Mama Hearts Care Kit, including a home blood pressure monitor, low dose aspirin, and culturally tailored educational materials. At the healthcare provider level, burnout and compassion fatigue will be addressed through skill-building activities, including training in the Community Resilience and Mindfulness-Based Stress Reduction. At the community level, Loving Connection will provide proactive material and social support through Community Health Workers, text messaging-based communication, a medical legal partnership, and capacity-building support for community-based organizations.

Locations (1)

University of North Carolina

Chapel Hill, North Carolina, United States