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

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

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.

Study Overview

• Status: Completed
• Conditions: Familial Dysautonomia; Tay Sachs Disease; Canavan Disease
• Intervention / Treatment: Other: Online pre-test genetic education tool

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montréal General Hospital (MUHC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: In-person counselling; 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.
Active Comparator: Online pre-test genetic education tool; Use of a web-based pre-test education program, wherein the information from a typical genetic counselling session for carrier screening in Ashkenazi Jewish individuals is presented.	Other: Online pre-test genetic education tool; See Arm Descriptions above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of Ashkenazi Jewish genetic conditions	Evaluated by questionnaire developed specifically for this study.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient anxiety	Evaluated by 6-item short form state trait anxiety inventory (Becker and Marteau 1992)	1 hour
Satisfaction with web-based/in-person genetic counselling	Assessed by questionnaire, developed from pre-existing genetic counselling research (Shiloh et al. 1990; Yip et al. 2003)	1 hour
Perceived risk of having a child with an Ashkenazi Jewish genetic condition	Evaluated by questionnaire developed specifically for this study.	1 hour

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Guillaume Sillon, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Technology; Genetic Counseling; Ashkenazi Jewish; Carrier screening
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Demyelinating Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Heredodegenerative Disorders, Nervous System; Lipid Metabolism Disorders; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Nervous System Malformations; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Lipidoses; Lipid Metabolism, Inborn Errors; Leukoencephalopathies; Polyneuropathies; Hereditary Central Nervous System Demyelinating Diseases; Gangliosidoses, GM2; Gangliosidoses; Hereditary Sensory and Autonomic Neuropathies; Primary Dysautonomias; Autonomic Nervous System Diseases; Tay-Sachs Disease; Canavan Disease; Dysautonomia, Familial
• Other Study ID Numbers: 3281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of study results in a peer-reviewed journal.