Clinical trial NCT01999257: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tay Sachs Disease
Canavan Disease
Familial Dysautonomia
Keywords: Genetic Counseling
Technology
Ashkenazi Jewish
Carrier screening
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Knowledge of Ashkenazi Jewish genetic conditions
timeFrame: 1 hour
Secondary outcomes:
measure: Patient anxiety
timeFrame: 1 hour
measure: Satisfaction with web-based/in-person genetic counselling
timeFrame: 1 hour
measure: Perceived risk of having a child with an Ashkenazi Jewish genetic condition
timeFrame: 1 hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital (MUHC)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Guillaume Sillon, MSc
role: PRINCIPAL_INVESTIGATOR
References: