NL-OMON27057
Recruiting
Not Applicable
Evaluation of a tailored approach towards informing family members at risk of inherited cardiac diseases: a randomized clinical trial
Academic Medical Center, University Medical Center Groningen & University Medical Center Utrecht0 sites425 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Predictive genetic testing, inherited cardiac diseases, inform family members at risk, tailored
- Sponsor
- Academic Medical Center, University Medical Center Groningen & University Medical Center Utrecht
- Enrollment
- 425
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study population consists of:
- •(1\) Index patients with an inherited cardiac disease and a putative pathogenic mutation (i.e., class 4 or 5 mutation): (a) Index patients who are the first in their family to attend pre\-test genetic counselling about genetic testing for inherited cardiac diseases, (b) Index patients that have at least one alive adult family member at risk of inheriting the mutation, (c) Index patients who are aged 18 years or older, (d) Index patients who are able to read and write Dutch. For final enrolment: Index patients who have a putative pathogenic mutation detected at the DNA test.
- •(2\) Their first\-degree, and second\-degree family members in case of a deceased connecting first\-degree family member that is affected or suspected to be affected (in case of sudden cardiac death), who are supposed to have a 50% risk of inheriting the disease\-causing mutation. (a) Family members who are aged 18 years and older, (b) Family members who are able to read and write Dutch.
Exclusion Criteria
- •(1\) Index patients and family members who have cognitive functioning problems and therefore are not able to provide informed consent.
Outcomes
Primary Outcomes
Not specified
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