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临床试验/NCT01176019
NCT01176019已完成1 期

An Interactive Informed Consent and Education Program for Pregnant Women

Northwestern University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Difference in understanding/knowledge gain as compared to control

研究概览

简要总结

The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.

详细描述

Women face a variety of medical decisions during pregnancy and childbirth. While there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. Issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. Studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. Women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. ArchieMD, Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. We hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. In Phase I, we will prototype an interactive patient education program for prenatal screening and amniocentesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Pregnant woman (6-26 weeks gestation)
  • •Over 18 years of age

排除标准

  • •Non-English speaking

研究组 & 干预措施

Interactive Video

Experimental

In addition to standard care, the experimental arm will receive an interactive video designed to inform and educate patients about the choices that exist concerning prenatal screening and diagnosis.

干预措施: Information about Prenatal Screening and Diagnosis (Device)

Control

No Intervention

A control arm will receive standard care, which is the opportunity to meet with a genetic counselor.

结局指标

主要结局

Difference in understanding/knowledge gain as compared to control

时间窗: Post-test and 2 week follow-up

Open-ended and T/F questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women improves understanding and expectations of prenatal screening and diagnostic tests in a group of pregnant women patients.

次要结局

  • REALM(Post-test)
  • eHEALS(Post-test)
  • Attitudes towards/satisfaction with interactive video(Post-test)

研究者

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

William Grobman

Associate Professor

Northwestern University

研究点 (2)

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