Maternal HealthWeCABNCT05916534
We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare
A study testing WeCAB Intervention in people with Maternal Health and Pregnant Women, run by State University of New York - Downstate Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Maternal Health, Pregnant Women
- What is being tested?
- WeCAB Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Hospital at Downstate
Brooklyn, New York, 11203
Steven Levine, MD, 718-270-3188, steven.levine@downstate.edu
Nadege Gilles, MPH, 718-270-7786, nadege.gilles@downstate.edu
About this study
Official title: Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care
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
- Being tested
- WeCAB Intervention
- Keywords
- Digital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeCAB InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WeCAB Intervention | Experimental | Not described Receives: Behavioral: WeCAB Intervention |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of postpartum care
Initiation of postpartum care within 6 weeks of delivery
Measured: 13 weeks until 3 months postpartum
Secondary outcomes (1)
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.
Measured: 13 weeks until 3 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start20 Nov 2023
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Afable, PHD, Principal investigator, SUNY Downstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916534
- Sponsor's protocol ID
- 1R21NR020706-01
- Acronym
- WeCAB
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care
- ClinicalTrials.gov ID
- NCT05916534
- Acronym / sponsor ID
- WeCAB / 1R21NR020706-01
- Conditions
- Maternal Health, Pregnant Women
- Keywords
- Digital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WeCAB Intervention | Experimental | Behavioral: WeCAB Intervention |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeCAB InterventionThe 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. | Behavioural | WeCAB Intervention |
Primary outcome
Initiation of postpartum care
Time frame: 13 weeks until 3 months postpartum
Initiation of postpartum care within 6 weeks of delivery
1 secondary outcome
Maternal death
Time frame: 13 weeks until 3 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Maternal Health
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The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
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Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
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Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee Afable, PHD principal investigator
SUNY Downstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeCAB Intervention in people with Maternal Health and Pregnant Women, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimee Afable, PHD (718-270-6397, aimee.afable@downstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of postpartum care (time frame: 13 weeks until 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.