Use of Videos to Improve Patient Knowledge on Prenatal Genetics

NCT03816423 | Completed

• 1 other identifier: 00035994
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options.

Conditions

Aneuploidy; Birth Defect

Keywords

patient education; genetic counseling

Outcome Measures

Primary Outcomes (2)

• Knowledge score

  Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the "Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

  same day for both groups

• Knowledge score change

  Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

  same day for both groups

Study Arms (2)

Traditional counseling

NO INTERVENTION

Patients will undergo routine prenatal care visit with clinical practicioner only

video group

EXPERIMENTAL

Participants randomized to the intervention group (video education) will view the prenatal screening video "How to Decide About Prenatal Genetic Testing," followed by a routine prenatal appointment.

Other: video

Interventions

video OTHER

Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.

video group

Eligibility Criteria

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

You may qualify if:

• pregnancy, english or spanish-speaking

You may not qualify if:

• minors \<18 years old,
• \> 21 completed weeks of gestational age,
• prior genetic counseling during current pregnancy
• fetus with known ultrasound abnormality

Sponsors & Collaborators

• University of South Florida: lead
• Tampa General Hospital: collaborator

Study Sites (1)

Genesis Healthpark- TGH

Tampa, Florida, 33609, United States

Location

MeSH Terms

Conditions

Aneuploidy; Congenital Abnormalities

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Karla Leavitt, MD, MPH

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Primary purpose: assess and compare patient knowledge on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video. All participants will complete a 15-item questionnaire on prenatal genetic screening options at baseline and after routine prenatal care visit. Participants randomized to the control group, will have a routine prenatal care appoinment, while the intervention group will watch a pre-appointment 4.5 minute educational video entitled "How to decide about prenatal genetic testing".

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: May 30, 2019
• Primary Completion: January 24, 2020
• Study Completion: May 12, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)