We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare

Pregnant Women Clinical Trial

— WeCAB  

Official title:

Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916534
• Other study ID #: 1R21NR020706-01
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: State University of New York - Downstate Medical Center
• Contact: Aimee Afable, PHD
• Phone: 718-270-6397
• Email: aimee.afable[@]downstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care. The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation. Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Eligible participants for the pilot RCT will be patients
• aged 18-49 years (childbearing age)
• residing in a Central Brooklyn zip code
• self-reporting as Black,
• who speak English or Haitian Creole, and
• plan to deliver or present for delivery at University Hospital at Downstate (UHD).
• In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.

Exclusion Criteria:

• Patients planning to move outside of New York City in the ensuing 3 months post-partum
• Patients demonstrating an impairment that limits their ability to provide informed consent.

Related Conditions & MeSH terms

• Maternal Health
• Pregnant Women

Intervention

Behavioral:
• WeCAB Intervention
The WeCAB intervention will use a dedicated WeCAB community health worker who will administer a social determinants of health (SDOH) tool and use digital care navigation to monitor closed loop referrals.

Locations

Country	Name	City	State
United States	University Hospital at Downstate	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of postpartum care	Initiation of postpartum care within 6 weeks of delivery	13 weeks until 3 months postpartum
Secondary	Maternal death	Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.	13 weeks until 3 weeks postpartum