AzTrials
AzTrials

Hypertensive Disorder of PregnancyNCT06744231

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

A study testing Thriving Hearts in people with Hypertensive Disorder of Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Hypertensive Disorder of Pregnancy
What is being tested?
Thriving Hearts
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17,500 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥15 and ≤55
  • Had a live birth at >=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
  • 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

Who cannot join

  • < 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • University of North Carolina

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the detailed description

Birthing people in the United States experience unacceptable rates of severe maternal morbidity (SMM) and maternal mortality (MM). Hypertensive disorders of pregnancy (HDP) are a major contributor: among individuals who died during the birth hospitalization, one in three had an HDP diagnosis. Populations that have experienced structural racism are disproportionately affected. Compared with white birthing people, Black birthing people with HDP are more likely to experience severe morbidity, and they are 3.7 times more likely to die from HDP complications. To address the root causes of these disparities, multicomponent strategies are urgently needed. The overarching goal of Thriving Hearts is to implement such a multi-level intervention through Local Health Departments (LHDs), cultivating 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 HDP and its complications through support and connection at the individual, healthcare provider, and community level. At the individual level, Mama Hearts maternity care will provide evidence-based, culturally tailored, holistic preventative care for pregnant people at risk for HDP. At the healthcare provider level, the project will address burnout and compassion fatigue among LHD staff and community healthcare providers through healing-centered, trauma-informed care. At the community level, Loving Connection will deploy community health workers and an integrated medical-legal partnership to provide proactive support through universal, strength-based assistance in a mutual aid context, building awareness of local resources and cultivating spaces for community support, connection, and joy.

The Thriving Hearts study uses a hybrid type 1 effectiveness-implementation design. To quantify effectiveness, the team will conduct a pragmatic, stepped-wedge, cluster randomized trial, implementing the intervention through LHDs. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in pairs in a randomly assigned sequence, at 9-month intervals. The team will systematically document usual care in each county. To inform future scale-up and dissemination, the team will conduct a mixed methods implementation evaluation.

The team will use this approach to accomplish the following specific aims: 1) Quantify the extent to which Thriving Hearts reduces incidence of HDP and associated complications and increases uptake of support resources among birthing people in the ten Thriving Hearts counties, using PCORnet, Carolina Cost and Quality Initiative Claims, Birth Certificate, and State Hospital Discharge data. 2) Quantify the extent to which Thriving Hearts improves patient-reported experiences and outcomes, measured through cross-sectional surveys of a subset of postpartum people in each county. 3) Quantify the extent to which healing-centered, trauma-informed care improves health team effectiveness and well-being, measured using cross-sectional surveys of professional quality of life and wellbeing. 4) Identify factors that affect implementation of the Thriving Hearts program at health department- and community-levels using the Consolidated Framework for Implementation Research 2.0.

The study population will include all individuals who give birth in the 10 Thriving Hearts counties, including Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person Counties. In 2021, there were 26,900 births in these counties, of whom 29% were non-Hispanic Black, 19% were Hispanic, and 43% were non-Hispanic white. Over the five-year comparative effectiveness study, the team anticipates that there will be ~140,000 births in the participating counties, providing ample power to assess outcomes in the full sample and to perform stratified analyses to test the extent to which Thriving Hearts reduces disparities in processes, experiences, and outcomes.

The study's primary outcome is the incidence of HDP during pregnancy, birth, or within 28 days postpartum, indexed by clinical data (PCORnet), diagnosis codes, and documentation on the birth certificate. Among Thriving Hearts county residents who birthed at UNC-affiliated hospitals from January 2019 through March 2023, 20.4% of Black patients and 17.4% of white patients had a diagnosis of HDP. The team hypothesizes that Thriving Hearts will reduce HDP incidence by 20%, consistent with effect sizes reported for several subcomponents of the multilevel intervention.

Secondary outcomes include clinical processes (first-trimester enrollment Medicaid and WIC, postpartum visit attendance, acute care utilization) and outcomes (HDP morbidity, severe maternal morbidity); patient-reported experiences (person-centered maternity care, autonomy, respectful care) and outcomes (wellbeing, mental health, social support, maternal function); and health care team-reported experience (addressing health-related social needs) and outcomes (wellbeing, professional quality of life, secondary trauma symptoms).

Being tested
Usual Care, Thriving Hearts
Keywords
Community health workers, Medical Legal Partnership, Home blood pressure monitoring, Low dose aspirin, Community Resilience Model, Trauma-informed care, Healing Centered Engagement, Sense of community, Person-centered maternity care
Medical subject headings
Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareOther

    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.

  • Thriving HeartsBehavioural

    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.

Study groups in NCT06744231
Study groupRoleWhat they receive
Pre-interventionPlacebo comparatorIn the pre-intervention sequence(s), pregnant and parenting people in participating counties will experience treatment-as-usual.
Receives: Other: Usual Care
Post-interventionActive comparatorIn the post-intervention sequence(s), pregnant and parenting people in participating counties will experience care enhanced with Thriving Hearts components, including point-of-care HDP prevention, health care providers equipped with resources for coping with secondary trauma, and proactive provision of social and material support.
Receives: Behavioral: Thriving Hearts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypertensive Disorder of Pregnancy

    Population-level incidence of hypertensive disorders of pregnancy. The primary outcome population consist of all births to residents of the 10 Thriving Hearts counties between January 1, 2025 and June 30, 2029. The outcome is ascertained using secondary data from birth certificates, electronic health records, and claims data. Informed consent is not obtained from individuals for this secondary data-based ascertainment.

    Measured: Between admission for delivery and 4 weeks postpartum for births occurring between January 1, 2025 and June 30, 2029, as determined from EMR, claims, and administrative data.

Secondary outcomes (5)
  1. Change in Brief Professional Quality of Life Score among people who serve pregnant women in Thriving Hearts Counties

    The Brief Professional Quality of Life scale is a measure of compassion satisfaction, burnout, and secondary traumatic stress. assessed using a 5-point Likert scale: 1 = Never (0 days), 2 = Rarely (1 day), 3 = Sometimes (2-3 days), 4 = Often (4-5 days), 5 = Always (6-7 days). Scores range from 12-60 with higher scores associated with worse professional quality of life.

    Measured: Cross-sectional survey of individuals who serve pregnant women in Thriving Hearts counties, repeated during each of the six study time periods, at months 6, 15, 24, 33, 42, and 51.

  2. Change in World Health Organization (WHO)-5 Wellbeing Index among people who serve pregnant women in Thriving Hearts Counties

    The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive statements rated using Likert questions ranging from 5 (all the time) to 0 (never), which tap into the subjective well-being of the respondents. Scores range from 0-100 (raw score is multiplied by 4). Higher scores = higher wellbeing.

    Measured: Cross-sectional survey of individuals who serve pregnant women in Thriving Hearts counties, repeated during each of the six study time periods, at months 6, 15, 24, 33, 42, and 51.

  3. Person-Centered Prenatal Care Scale Score, postpartum survey

    The Person-Centered Prenatal Care Scale is a validated tool that can be used to measure person-centered prenatal care that reflects the experiences of people of color consisting of 26 items. Scores range from a minimum of 16 to a maximum of 78 with higher scores indicate more person-centered care.

    Measured: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

  4. Brief Sense of Community Scale, postpartum survey

    The BSCS was designed to assess the dimensions of needs fulfillment, group membership, influence, and emotional connection with 8 questions rated using a 5-point, Likert-type response option format ranging from strongly agree to strongly disagree. Scores range from 8-40 wtih higher scores indicating a stronger sense of community.

    Measured: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

  5. World Health Organization (WHO)-5 Wellbeing Index, postpartum survey

    The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive statements rated using Likert questions ranging from 5 (all the time) to 0 (never), which tap into the subjective well-being of the respondents. Scores range from 0-100 (raw score is multiplied by 4). Higher scores = higher wellbeing.

    Measured: Cross-sectional survey of postpartum people in Thriving Hearts counties 2-6 months following birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators plan a multisite step-wedge cluster randomized trial to test the extent to which the a Local Health Department led population health program reduces rates of hypertensive disorders of pregnancy (HDP, primary outcome), patient experience measures (secondary outcomes) and maternity health worker quality of life (secondary outcome). The Thriving Hearts program will be implemented in a stepped-wedge design with six nine-month time periods, 3 sequences, and 3 or 4 counties in each sequence, with 10 counties in total.
Masking
None (open label)
Enrolment
17,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744231
Sponsor's protocol ID
24-2138
Status last verified
Apr 2026
First submitted
12 Dec 2024
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Questions about this trial

What is this clinical trial studying?

A study testing Thriving Hearts in people with Hypertensive Disorder of Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypertensive Disorder of Pregnancy (time frame: Between admission for delivery and 4 weeks postpartum for births occurring between January 1, 2025 and June 30, 2029, as determined from EMR, claims, and administrative data.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in