Efficacy Study of an Online Educational Module Before Carrier Genetic Screening in Persons of Ashkenazi Jewish Descent.

Brief Title

Efficacy Study of an Online Educational Module Before Carrier Genetic Screening in Persons of Ashkenazi Jewish Descent.

Official Title

Assessing the Outcomes of Web-based Pre-test Educational Module for Carrier Genetic Screening in Individuals of Ashkenazi Jewish Descent

Brief Summary

      The investigators have developed a new website to educate persons of Ashkenazi Jewish
      ancestry about their increased risk for having children with certain genetic conditions, and
      the genetic testing the investigators offer. This study aims to pilot the website to find out
      whether it is effective and to learn what the investigators can improve.

      Participants in the study will be assigned to one of two conditions:

        1. Standard in-person genetic counselling session to learn about inheritance of Ashkenazi
           Jewish genetic conditions and genetic testing. Participants will fill out two short
           questionnaires, one before and one after the genetic counselling session. They will then
           be given a requisition form to undergo blood draw for genetic testing at the Montreal
           General Hospital test centre.

        2. Use of a web-based pre-test genetic counselling tool to learn about inheritance of
           Ashkenazi Jewish genetic conditions and genetic testing. They will fill out two short
           questionnaires, one before, and one after using the web-based tool. They will then be
           electronically sent a requisition form to undergo blood draw for genetic testing at the
           Montreal General Hospital test centre.

      In both conditions, genetic test results will be communicated by telephone once they are
      available. Participants' genetic test results will not be used in any way for the study.
    

Detailed Description

      In Montreal, individuals of Ashkenazi Jewish descent are eligible to have carrier screening
      for three genetic conditions: Tay-Sachs disease, Canavan disease, and familial dysautonomia.
      The investigators have developed a new website to educate persons of Ashkenazi Jewish
      ancestry about their increased risk for having children with these genetic conditions, and
      the genetic testing the investigators offer. This study aims to pilot the website to find out
      whether it is effective and to learn what the investigators can improve. Specifically, the
      investigators will measure knowledge acquisition, level of anxiety, and degree of
      satisfaction with their experience.

      Participants in the study will be assigned to one of two conditions:

        1. Standard in-person genetic counselling session to learn about inheritance of Ashkenazi
           Jewish genetic conditions and genetic testing. Participants will fill out two short
           questionnaires, one before and one after the genetic counselling session. These
           questionnaires assess demographic information, knowledge regarding the three genetic
           conditions listed above, feelings and anxiety levels, e-health literacy, and overall
           satisfaction. They will then be given a requisition form to undergo blood draw for
           genetic testing at the Montreal General Hospital test centre.

        2. Use of a web-based pre-test genetic counselling tool to learn about inheritance of
           Ashkenazi Jewish genetic conditions and genetic testing. They will fill out two short
           questionnaires, one before, and one after using the web-based tool. These questionnaires
           are similar to those in the condition above, except there will also be questions
           regarding the utility of the web-based tool and ways to improve the tool. Participants
           will then be electronically sent a requisition form to undergo blood draw for genetic
           testing at the Montreal General Hospital test centre.

      In both conditions, genetic test results will be communicated by telephone once they are
      available. Participants' genetic test results will not be used in any way for the study.
    

Study Type

Interventional

Primary Outcome

Knowledge of Ashkenazi Jewish genetic conditions

Secondary Outcome

 Patient anxiety

Condition

Tay Sachs Disease

Intervention

Online pre-test genetic education tool

Study Arms / Comparison Groups

 In-person counselling

Description:  Similar to standard of care, wherein Ashkenazi Jewish individuals seeking carrier genetic screening meet a genetic counsellor for an in-person education and counselling session.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

60

Start Date

July 2014

Completion Date

August 2017

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  At least one grandparent of Ashkenazi Jewish descent

          -  Access to computer at home and computer literate

        Exclusion Criteria:

          -  Participant or participant's partner is pregnant at time of study

          -  Family history of an Ashkenazi Jewish genetic condition
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Guillaume Sillon, MSc, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT01999257

Organization ID

3281

Responsible Party

Principal Investigator

Study Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Sponsor

Guillaume Sillon, MSc, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

Verification Date

August 2017