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Prenatal Computer-Aided Genetics Education Module (CAGEM)

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ClinicalTrials.gov Identifier: NCT03449225
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Manesha Putra, MD, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Autosomal Recessive Disorder Aneuploidy Other: Computer-Aided Genetic Education Module Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Development of a Computer-Aided Genetics Education Module (CAGEM) on Screening and Testing for Fetal Chromosome Conditions and Carrier Status: A Clinical Trial
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.
Other: 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 Measures :
  1. 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. ]
    Survey will be used to assess subjects' knowledge on prenatal genetics


Secondary Outcome Measures :
  1. Testing Intention [ 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. ]
    Survey will be used to assess subjects' intention to accept or decline


Other Outcome Measures:
  1. Software Acceptability [ Time Frame: 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. ]
    Survey will be used to assess the software acceptability among subjects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known history of genetic disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449225


Contacts
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Contact: Manesha Putra, MD 7732419231 manesha.putra@gmail.com

Locations
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United States, Michigan
Hutzel Women's Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Manesha Putra, MD    773-241-9231    manesha.putra@gmail.com   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Manesha Putra, MD Wayne State University

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Responsible Party: Manesha Putra, MD, Obstetrics and Gynecology Resident Physician, Wayne State University
ClinicalTrials.gov Identifier: NCT03449225     History of Changes
Other Study ID Numbers: 115217B3E
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes