跳至主要内容
临床试验/NCT06298214
NCT06298214
Enrolling By Invitation
不适用

Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

Elizabeth F Sutton, PhD1 个研究点 分布在 1 个国家目标入组 500 人2024年5月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Postpartum
发起方
Elizabeth F Sutton, PhD
入组人数
500
试验地点
1
主要终点
Postpartum visit attendance
状态
Enrolling By Invitation
最后更新
去年

概览

简要总结

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question[s] the study aims to answer are:

  • Can the Her Health program increase access to healthcare in the first year postpartum?
  • Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

注册库
clinicaltrials.gov
开始日期
2024年5月29日
结束日期
2026年6月1日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

发起方
Elizabeth F Sutton, PhD
责任方
Sponsor Investigator
主要研究者

Elizabeth F Sutton, PhD

Director of Scientific Research

Woman's

入排标准

入选标准

  • At least 16 years old at the time of consent.
  • Gave birth within 7 days before randomization
  • Medicaid enrolled
  • Address of residence within a disadvantaged area (ADI\>5).
  • Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent

排除标准

  • Use of private health insurance exclusively
  • Does not speak English.
  • Plans to move out of state during the study time period
  • Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.
  • Unwilling to provide informed consent
  • Unwilling to be randomized.

结局指标

主要结局

Postpartum visit attendance

时间窗: 12 weeks postpartum

Visit attended between 6-12 weeks of delivery (yes/no)

次要结局

  • Health literacy(12 months postpartum)
  • Self-efficacy(12 months postpartum)
  • Medical trust(12 months postpartum)
  • Healthcare costs(12 months postpartum)

研究点 (1)

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