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

NCT05916534 | Unknown

• 1 other identifier: 1R21NR020706-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Health; Pregnant Women

Keywords

Digital

Outcome Measures

Primary Outcomes (1)

• Initiation of postpartum care

  Initiation of postpartum care within 6 weeks of delivery

  13 weeks until 3 months postpartum

Secondary Outcomes (1)

• Maternal death

  13 weeks until 3 weeks postpartum

Study Arms (2)

WeCAB Intervention

EXPERIMENTAL

Behavioral: WeCAB Intervention

Usual Care

NO INTERVENTION

Interventions

WeCAB Intervention BEHAVIORAL

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.

WeCAB Intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

University Hospital at Downstate

Brooklyn, New York, 11203, United States

RECRUITING

Study Officials

• Aimee Afable, PHD

  SUNY Downstate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Afable, PHD

CONTACT

718-270-6397; aimee.afable@downstate.edu

Sandra Bruening, MS

CONTACT

518-217-2531; sandra.bruening@downstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: November 20, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)