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临床试验/NCT05916534
NCT05916534Unknown不适用

Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care

State University of New York - Downstate Medical Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Initiation of postpartum care

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Initiation of postpartum care

时间窗: 13 weeks until 3 months postpartum

Initiation of postpartum care within 6 weeks of delivery

次要结局

  • Maternal death(13 weeks until 3 weeks postpartum)

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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