Use of Videos to Improve Patient Knowledge on Prenatal Genetics

NCT ID: NCT03816423

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2020-05-12

Brief Summary

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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.

Detailed Description

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During pregnancy, women are routinely counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing options to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. A standardized educational video on prenatal screening may enhance a patient's understanding and knowledge of testing and support more informed decisions.

The objective of this study is to evaluate and compare patient knowledge scores on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

Conditions

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Aneuploidy Birth Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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".
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Traditional counseling

Patients will undergo routine prenatal care visit with clinical practicioner only

Group Type NO_INTERVENTION

No interventions assigned to this group

video group

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.

Group Type EXPERIMENTAL

video

Intervention Type OTHER

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

Interventions

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video

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnancy, english or spanish-speaking

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tampa General Hospital

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karla Leavitt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Genesis Healthpark- TGH

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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00035994

Identifier Type: -

Identifier Source: org_study_id

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