Recruiting

Genetics Education

Sponsor:

Wayne State University

Code:

NCT03449225

Conditions

Autosomal Recessive Disorder

Aneuploidy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Computer-Aided Genetic Education Module

Study Details

Brief summary:

A standard part of obstetrical care is offering prenatal genetic screening. Numerous professional guidelines have emphasized the importance of pretest counseling for prenatal genetic screenings. Informed consent includes the optional nature of the test, information on the conditions being screened, possible test results, implication of each result, and the type of test offered (screening or diagnostic). This responsibility falls on the physician in a busy clinic. Technology may be able to address this limitation and give consistent pretest counseling for patients waiting for their appointment. This study is looking to evaluate the use of computer-aided genetics education module for facilitating decision making about prenatal genetic screening and testing for fetal chromosome conditions and carrier status.

Conditions

Autosomal Recessive Disorder

Aneuploidy

Study ID

NCT03449225

Start date

Mar 7, 2018

Status verified date

Apr, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant with gestational age of less than 24 weeks
  • Good understanding of spoken English

Exclusion Criteria:

  • Known history of genetic disorder

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Control Arm

The participant will be given a digital device (IPad or Kindle Fire) to complete a pre-education survey (web-based pre-intervention survey housed on the Qualtrics platform). Once the survey is complete, the participant will proceed with standard education, provided by a resident/physician in the clinic, about prenatal screening and testing for chromosome conditions and for carrier status. Once the standard education has been completed, the participant will be approached to complete a post-education survey which includes questions about knowledge, intent to have or decline screening or testing, and demographic variables.

experimental: Test Arm

• The participant she will be given a digital device on which to access the computer aided genetics educational module. Prior to accessing the module, the patient will be asked to complete a pre-education survey (web-based pre-intervention survey housed on the Qualtrics platform). Once she has completed the survey, she will interact with the Computer-Aided Genetic Education Module which is tailored for her clinical situation. Once the participant has completed reviewing the module, she will be asked to complete the web-based post-module survey which includes questions about knowledge, intent to have or decline screening or testing, acceptability of the module, and demographic variables.

Interventions

Computer-Aided Genetic Education Module

Subjects will be provided with an electronic device to view Computer-Aided Genetic Education Module (CAGEM) software. This is an interactive software designed to provide subjects with tailored information regarding prenatal screening options for carrier status and aneuploidy.

Primary outcome measure

  • Knowledge of Genetics [ Time Frame: Participant will be assessed from the time of randomization and again after clinical encounter (and intervention, for the study arm). The total estimated time will be approximately 1 hour since randomization. ]

Central Contacts and Locations

Central contacts

Manesha Putra, MD

7732419231manesha.putra@gmail.com

Locations

Hutzel Women's Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Manesha Putra, MD

773-241-9231manesha.putra@gmail.com

More Information

Sponsor

Wayne State University

Last update posted

May 2, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2019-05-02.