Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-07 @ 7:33 PM
Study NCT ID:
NCT05916534
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of postpartum care', 'timeFrame': '13 weeks until 3 months postpartum', 'description': 'Initiation of postpartum care within 6 weeks of delivery'}], 'secondaryOutcomes': [{'measure': 'Maternal death', 'timeFrame': '13 weeks until 3 weeks postpartum', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital'], 'conditions': ['Maternal Health', 'Pregnant Women']}, 'descriptionModule': {'briefSummary': '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.\n\nThe WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants for the pilot RCT will be patients\n* aged 18-49 years (childbearing age)\n* residing in a Central Brooklyn zip code\n* self-reporting as Black,\n* who speak English or Haitian Creole, and\n* plan to deliver or present for delivery at University Hospital at Downstate (UHD).\n* 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.\n\nExclusion Criteria:\n\n* Patients planning to move outside of New York City in the ensuing 3 months post-partum\n* Patients demonstrating an impairment that limits their ability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05916534', 'acronym': 'WeCAB', 'briefTitle': 'We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Downstate Medical Center'}, 'officialTitle': 'Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care', 'orgStudyIdInfo': {'id': '1R21NR020706-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21NR020706-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WeCAB Intervention', 'interventionNames': ['Behavioral: WeCAB Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'WeCAB Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['WeCAB Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Levine, MD', 'role': 'CONTACT', 'email': 'steven.levine@downstate.edu', 'phone': '718-270-3188'}, {'name': 'Nadege Gilles, MPH', 'role': 'CONTACT', 'email': 'nadege.gilles@downstate.edu', 'phone': '718-270-7786'}], 'facility': 'University Hospital at Downstate', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'centralContacts': [{'name': 'Aimee Afable, PHD', 'role': 'CONTACT', 'email': 'aimee.afable@downstate.edu', 'phone': '718-270-6397'}, {'name': 'Sandra Bruening, MS', 'role': 'CONTACT', 'email': 'sandra.bruening@downstate.edu', 'phone': '518-217-2531'}], 'overallOfficials': [{'name': 'Aimee Afable, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY Downstate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Downstate Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}