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临床试验/NCT06373367
NCT06373367进行中(未招募)不适用

Preeclampsia Educational Program Study

MemorialCare Health System2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
2
主要终点
Preeclampsia knowledge score - short

研究概览

简要总结

Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.

详细描述

Preeclampsia complicates approximately 8% of all pregnancies. While many patients improve following delivery, the disease process remains a leading cause for postpartum morbidity and mortality. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. There is a gap in the literature regarding effective, patient-centered educational tools specifically addressing these elements, especially in the postpartum period.

The investigators propose a pilot, randomized controlled trial of postpartum patients with preeclampsia. The intervention of interest is an illustration-based, educational mobile device application (app) focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum. The control for this study will be the same information in a text-only format, also accessed through a mobile device app.

The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.

Specific Aim 1: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention (short-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Specific Aim 2: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education >4 weeks post intervention (long-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at > 4 weeks post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

研究设计

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

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

  • Preeclampsia with or without severe features
  • Able to read and speak English
  • Consistent access to mobile device with QR-reading capability and ability to access mobile-device application.
  • Pre-and postnatal care provided by OB Clinic (resident clinic) or Magella (maternal-fetal medicine)

排除标准

  • Patient age < 18 years old
  • Non-English speaking
  • Current enrollment in another trial targeting postpartum preeclampsia parameters
  • Arm width >40cm (XL Cuff)

结局指标

主要结局

Preeclampsia knowledge score - short

时间窗: Measured at 24 hours postpartum

Short term preeclampsia knowledge score. Scored from 0-24, with 24 demonstrating the most correct answers to the assessment

次要结局

  • Preeclampsia knowledge score - long(Measured between 4 - 6 weeks postpartum)
  • GAD-7 score(Measured between 4-6 weeks postpartum)
  • 72 hour BP check(Measured 72 hours after hospital discharge)
  • Number of participants who attend a postpartum visit(Measured within 6 weeks postpartum)
  • Daily BP recordings(Measured within 6 weeks postpartum)
  • Accessed material(Measured at 6 weeks postpartum)
  • Unplanned readmission(Measured at 6 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Megan Oakes

MD MCSI

MemorialCare Health System

研究点 (2)

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