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Enrolling By Invitation
NCT06744231
Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
Conditions: Hypertensive Disorder of Pregnancy
Sex: All
Ages: 15 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 17500
Sponsor: University of North Carolina, Chapel Hill
Location: University of North Carolina Chapel Hill North Carolina
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.
Eligibility Criteria
Any individual who is pregnant or \=24 weeks in the past 6 months
* Listed the birthing parent's residential address on the birth certificate as within a Thriving Hearts county ( Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
* Are able to communicate in English or Spanish
Exclusion Criteria
* \< 15 or \> 55 years of age
* Did not have a live birth at \>= 24 weeks in the past 6 months
* Residential address not listed on birth certificate as one of the study counties
* Not able to communicate in either English
Cross-sectional survey of people who serve perinatal patients
To assess the effectiveness of the Healing Centered Engagement program, the team will conduct cross-sectional surveys of people who serve perinatal patients in Thriving Hearts counties, repeated during each of the six study time periods
Inclusion criteria:
* Age ≥ 18
* Provides services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
* Are able to communicate in English
Exclusion criteria:
* Age \< 18
* Does not provide services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
* Are unable to communicate in English
Source: ClinicalTrials.gov (NCT06744231). StuddyBuddy aggregates publicly available trial information.