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

NCT ID: NCT05916534

Last Updated: 2023-12-12

Study Results

Results pending

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.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

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.

Maternal Health Pregnant Women

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Digital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WeCAB Intervention

Group Type EXPERIMENTAL

WeCAB Intervention

Intervention Type 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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York - Downstate Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aimee Afable, PHD

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital at Downstate

Brooklyn, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aimee Afable, PHD

Role: CONTACT

Phone: 718-270-6397

Email: [email protected]

Sandra Bruening, MS

Role: CONTACT

Phone: 518-217-2531

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Steven Levine, MD

Role: primary

Nadege Gilles, MPH

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R21NR020706-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link