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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Guillaume Sillon, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01999257
First received: November 25, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Tay Sachs Disease
Canavan Disease
Familial Dysautonomia
Other: Online pre-test genetic education tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessing the Outcomes of Web-based Pre-test Educational Module for Carrier Genetic Screening in Individuals of Ashkenazi Jewish Descent

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Knowledge of Ashkenazi Jewish genetic conditions [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Evaluated by questionnaire developed specifically for this study.


Secondary Outcome Measures:
  • Patient anxiety [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Evaluated by 6-item short form state trait anxiety inventory (Becker and Marteau 1992)

  • Satisfaction with web-based/in-person genetic counselling [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Assessed by questionnaire, developed from pre-existing genetic counselling research (Shiloh et al. 1990; Yip et al. 2003)

  • Perceived risk of having a child with an Ashkenazi Jewish genetic condition [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Evaluated by questionnaire developed specifically for this study.


Estimated Enrollment: 60
Study Start Date: July 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999257

Contacts
Contact: Guillaume Sillon, MSc 514-934-1934 ext 43707 guillaume.sillon@muhc.mcgill.ca
Contact: Charity Fan, BSc AJscreeningstudy@gmail.com

Locations
Canada, Quebec
Montreal General Hospital (MUHC) Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Guillaume Sillon, MSc    514-934-1934 ext 43707    guillaume.sillon@muhc.mcgill.ca   
Contact: Charity Fan, BSc       AJscreeningstudy@gmail.com   
Principal Investigator: Guillaume Sillon, M.Sc.,CCGC         
Principal Investigator: Charity Fan, B.Sc.         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Guillaume Sillon, MSc McGill University Health Center
  More Information

No publications provided

Responsible Party: Guillaume Sillon, Genetic counsellor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01999257     History of Changes
Other Study ID Numbers: 3281
Study First Received: November 25, 2013
Last Updated: July 24, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ministère santé et services sociaux du Québec
Canada: Health Canada

Keywords provided by McGill University Health Center:
Genetic Counseling
Technology
Ashkenazi Jewish
Carrier screening

Additional relevant MeSH terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Dysautonomia, Familial
Tay-Sachs Disease
Canavan Disease
Nervous System Diseases
Hereditary Sensory and Autonomic Neuropathies
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Gangliosidoses, GM2
Gangliosidoses
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Metabolism, Inborn Errors
Lipidoses

ClinicalTrials.gov processed this record on August 25, 2014