Recruiting

Digital Behavioral Intervention

Sponsor:

State University of New York - Downstate Medical Center

Code:

NCT05916534

Conditions

Maternal Health

Pregnant Women

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

WeCAB Intervention

Study Details

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

Study ID

NCT05916534

Start date

Nov 20, 2023

Status verified date

Dec, 2023

Completion date

Aug, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: WeCAB Intervention

no intervention: Usual Care

Interventions

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.

Primary outcome measure

  • Initiation of postpartum care [ Time Frame: 13 weeks until 3 months postpartum ]

Central Contacts and Locations

Central contacts

Aimee Afable, PHD

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

Sandra Bruening, MS

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

Locations

University Hospital at Downstate

Recruiting

Brooklyn, New York, United States, 11203

Contacts

Steven Levine, MD

718-270-3188steven.levine@downstate.edu

Nadege Gilles, MPH

718-270-7786nadege.gilles@downstate.edu

More Information

Sponsor

State University of New York - Downstate Medical Center

Last update posted

Dec 12, 2023

Last verified

Dec, 2023

Keywords

  • Digital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Downstate Medical Center on 2023-12-12.