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Completed

NCT Number: NCT01999257

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital (MUHC)

Montreal, Quebec, H3G 1A4, Canada

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online pre-test genetic education tool

Other

See Arm Descriptions above.

Primary outcomes

  1. Knowledge of Ashkenazi Jewish genetic conditions

    Time frame: 1 hour

    Evaluated by questionnaire developed specifically for this study.

Secondary outcomes

  1. Patient anxiety

    Time frame: 1 hour

    Evaluated by 6-item short form state trait anxiety inventory (Becker and Marteau 1992)

  2. Satisfaction with web-based/in-person genetic counselling

    Time frame: 1 hour

    Assessed by questionnaire, developed from pre-existing genetic counselling research (Shiloh et al. 1990; Yip et al. 2003)

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

    Time frame: 1 hour

    Evaluated by questionnaire developed specifically for this study.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Dec 3, 2013
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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