跳至主要内容
临床试验/NCT05502510
NCT05502510已完成不适用

Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Naima Health LLC1 个研究点 分布在 1 个国家目标入组 12,344 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,344
试验地点
1
主要终点
Gestational Age at Birth

研究概览

简要总结

One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

详细描述

MyHealthyPregnancy (MHP) is an application that was developed using behavioral decision science principles. This study seeks to evaluate the effectiveness and efficacy of the application. MyHealthyPregnancy was offered to expectant mothers at the University of Pittsburgh Medical Center in conjunction with usual prenatal care. The primary objective is to compare the reduction in gestational age at birth between MHP and usual care cohorts. Secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the MHP and usual care cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Offered a prescription for MyHealthyPregnancy
  • 18+ years of age
  • Seeking care at a UPMC hospital
  • Delivered at a UPMC hospital

排除标准

  • 未提供

结局指标

主要结局

Gestational Age at Birth

时间窗: Baseline to 40 Weeks

Gestational age at birth will be measured using each patients electronic health record. The average treatment effect will be calculated using linear regression comparing MHP and usual care cohorts. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects gestational age at birth.

次要结局

  • Referrals to Behavioral Health Specialists(Baseline to 40 Weeks)
  • Attendance at Required Prenatal Appointments(Baseline to 40 Weeks)
  • Prenatal Births(Baseline to 37 Weeks)
  • Attendance at Prenatal Appointments(Baseline to 40 Weeks)
  • Referrals to Social Workers(Baseline to 40 Weeks)
  • Gestational Weight Gain(Baseline to 40 Weeks)
  • Depression Rates(Baseline to 40 Weeks)
  • Anxiety Rates(Baseline to 40 Weeks)
  • Preeclampsia(Baseline to 40 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验