Holistic Care Partner Program Feasibility and Acceptability
NCT ID: NCT06520566
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
55 participants
INTERVENTIONAL
2024-07-15
2026-08-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Community-based Patient Navigation
NCT05588245
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
NCT06245057
Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
NCT07157059
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
NCT06353256
RESTORE - Phase II
NCT06349070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Black Birthing Patients enrolled in Holistic Care Partner Program (HCP)
Black birthing patients enrolled in HCP will be invited to participate in a brief survey and/or a qualitative interview throughout 1 year of their enrollment.
Holistic care partner perinatal nurse navigation
The nurse navigators assess patient medical, social, and structural needs at enrollment, 20-, 28-, and 36-weeks gestation; and at 1-week, and 3, 6, and 9 months postpartum. They provide coordination, support, and referrals, and enhanced communication with or escalate concerns to the primary physician as indicated. The nurse navigator tailors additional visits to the individual needs of the patients (for example, managing comorbidities, social isolation, breastfeeding support). Participants also have access to a Black woman-led support group during pregnancy and the first postpartum year, and access to Black woman-led childbirth and lactation classes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Holistic care partner perinatal nurse navigation
The nurse navigators assess patient medical, social, and structural needs at enrollment, 20-, 28-, and 36-weeks gestation; and at 1-week, and 3, 6, and 9 months postpartum. They provide coordination, support, and referrals, and enhanced communication with or escalate concerns to the primary physician as indicated. The nurse navigator tailors additional visits to the individual needs of the patients (for example, managing comorbidities, social isolation, breastfeeding support). Participants also have access to a Black woman-led support group during pregnancy and the first postpartum year, and access to Black woman-led childbirth and lactation classes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Enrolled in the HCP program while pregnant or within 6 weeks postpartum
3. Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care
4. Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.
5. Comfortable reading and/or speaking English (approximately 95% of Black women speak English)
6. Are 18 years or older
Exclusion Criteria
2. Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.
3. Not enrolled in the FGP NYULH for obstetric care
4. Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.
5. Is not 18 years or older
6. Multiple gestation
7. Significant fetal anomaly requiring exceptional care
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey Lyndon, PhD, RNC, FAAN
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Health
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-00821
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.