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Clinical Trials/NCT01176019
NCT01176019
Completed
Phase 1

An Interactive Informed Consent and Education Program for Pregnant Women

Northwestern University2 sites in 1 country150 target enrollmentAugust 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Northwestern University
Enrollment
150
Locations
2
Primary Endpoint
Difference in understanding/knowledge gain as compared to control
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Grobman

Associate Professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Non-English speaking

Outcomes

Primary Outcomes

Difference in understanding/knowledge gain as compared to control

Time Frame: 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.

Secondary Outcomes

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

Study Sites (2)

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