Skip to main content
Clinical Trials/NCT01176019
NCT01176019CompletedPhase 1

An Interactive Informed Consent and Education Program for Pregnant Women

Northwestern University4 sites in 1 country150 target enrollmentStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
150
Locations
4
Primary Endpoint
Difference in understanding/knowledge gain as compared to control

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Grobman

Associate Professor

Northwestern University

Study Sites (4)

Loading locations...

Similar Trials