Prenatal Computer-Aided Genetics Education Module (CAGEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03449225|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autosomal Recessive Disorder Aneuploidy||Other: Computer-Aided Genetic Education Module||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
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
|Contact: Manesha Putra, MDfirstname.lastname@example.org|
|United States, Michigan|
|Hutzel Women's Hospital||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Manesha Putra, MD 773-241-9231 email@example.com|
|Principal Investigator:||Manesha Putra, MD||Wayne State University|