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

NCT01999257 | Completed

• 1 other identifier: 3281
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Tay Sachs Disease; Canavan Disease; Familial Dysautonomia

Keywords

Genetic Counseling; Technology; Ashkenazi Jewish; Carrier screening

Outcome Measures

Primary Outcomes (1)

• Knowledge of Ashkenazi Jewish genetic conditions

  Evaluated by questionnaire developed specifically for this study.

  1 hour

Secondary Outcomes (3)

• Patient anxiety

  1 hour

• Satisfaction with web-based/in-person genetic counselling

  1 hour

• Perceived risk of having a child with an Ashkenazi Jewish genetic condition

  1 hour

Study Arms (2)

In-person counselling

NO INTERVENTION

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.

Online pre-test genetic education tool

ACTIVE COMPARATOR

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

Interventions

Online pre-test genetic education tool OTHER

See Arm Descriptions above.

Online pre-test genetic education tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one grandparent of Ashkenazi Jewish descent
• Access to computer at home and computer literate

You may not qualify if:

• Participant or participant's partner is pregnant at time of study
• Family history of an Ashkenazi Jewish genetic condition

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital (MUHC)

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Tay-Sachs Disease; Canavan Disease; Dysautonomia, Familial

Condition Hierarchy (Ancestors)

Gangliosidoses, GM2; Gangliosidoses; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Hereditary Central Nervous System Demyelinating Diseases; Leukoencephalopathies; Demyelinating Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Hereditary Sensory and Autonomic Neuropathies; Nervous System Malformations; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities

Study Officials

• Guillaume Sillon, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Genetic counsellor

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)