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

Not Applicable

Recruiting

• Conditions: Maternal Health; Pregnant Women
• Interventions: Behavioral: WeCAB Intervention

• Registration Number: NCT05916534
• Lead Sponsor: State University of New York - Downstate Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2023-11-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WeCAB Intervention	WeCAB Intervention	-

Primary Outcome Measures

Name	Time	Method
Initiation of postpartum care	13 weeks until 3 months postpartum	Initiation of postpartum care within 6 weeks of delivery

Secondary Outcome Measures

Name	Time	Method
Maternal death	13 weeks until 3 weeks postpartum	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.

Trial Locations

Locations (1)

University Hospital at Downstate; 🇺🇸 Brooklyn, New York, United States