Game-Based Decision Aid to Educate Pregnant Women About Prenatal Screening

NCT03441672 | Completed

• 1 other identifier: R21HD083832
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

Significant barriers exist for effectively informing women about prenatal screening in the clinical setting. This project developed and evaluated the efficacy of a game decision aid among pregnant women about prenatal screening in a randomized controlled study.

Conditions

Prenatal Disorder

Keywords

Prenatal Screening; Interactive educational technology

Outcome Measures

Primary Outcomes (1)

• Level of knowledge about prenatal screening and prenatal diagnostic testing

  prenatal screening knowledge is measured with a 23-item survey developed by an expert panel of genetic counselors, physicians, social scientists and data collection experts. All questions use a five point likert scale for response.

  Immediately after intervention

Secondary Outcomes (1)

• Documentation of decision to undergo prenatal screening

  Up to 4 weeks after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group interact with the game technology to learn about prenatal screening, in addition to usual care provided in the clinic.

Behavioral: Meaning of Screening

Control

NO INTERVENTION

Participants in the control group learn about prenatal screening through usual care in the clinic.

Interventions

Meaning of Screening BEHAVIORAL

Interactive technology game providing education about prenatal screening and what the results may mean.

Intervention

Eligibility Criteria

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

You may qualify if:

• English speaking
• less than 15 weeks gestation
• attending first obstetric visit
• low risk pregnancy

You may not qualify if:

• Non-English speaking
• High risk pregnancy
• Past 15 weeks gestation

Sponsors & Collaborators

• University of Utah: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Officials

• Erin Rothwell, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: November 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share