Prenatal Computer-Aided Genetics Education Module

NCT03449225 | Unknown

• 1 other identifier: 115217B3E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Knowledge of Genetics

  Survey will be used to assess subjects' knowledge on prenatal genetics

  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.

Secondary Outcomes (1)

• Testing Intention

  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.

Other Outcomes (1)

• Software Acceptability

  Participant will be assessed from the time after the completion of intervention material usage. This is a one time survey, total estimated time is approximately 10 minutes.

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Test Arm

EXPERIMENTAL

• 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.

Other: Computer-Aided Genetic Education Module

Interventions

Computer-Aided Genetic Education Module OTHER

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.

Test Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Known history of genetic disorder

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manesha Putra, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manesha Putra, MD

CONTACT

7732419231; manesha.putra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology Resident Physician

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 28, 2018
• Study Start: March 7, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

US (1)