An Interactive Informed Consent and Education Program for Pregnant Women

NCT01176019 | Completed Phase 1 DMC

• 1 other identifier: NIH-291
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Down Syndrome

Keywords

Amniocentesis; Chorionic Villus Sampling; First trimester screening; Down syndrome

Outcome Measures

Primary Outcomes (1)

• Difference in understanding/knowledge gain as compared to control

  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.

  Post-test and 2 week follow-up

Secondary Outcomes (3)

• eHEALS

  Post-test

• Attitudes towards/satisfaction with interactive video

  Post-test

• REALM

  Post-test

Study Arms (2)

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.

Device: Information about Prenatal Screening and Diagnosis

Control

NO INTERVENTION

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

Interventions

Information about Prenatal Screening and Diagnosis DEVICE

15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.

Interactive Video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• Northwestern University: lead
• ArchieMD: collaborator

Study Sites (2)

Northwestern Memorial Faculty Foundation (NMFF)

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital (NMH)

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Bill Grobman, M.D., M.B.A

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Michael Wolf, Ph.D, M.P.H

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Robert Levine, M.D.

  ArchieMD, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

US (2)