Virtual clinic for genetic counseling in inherited heart diseases
The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling: Evaluation of Uptake, Psychological Impact and Satisfaction Among Users
This study is testing a new online genetic counseling service for families of people with inherited heart diseases to see if it gets more relatives involved compared to traditional in-person counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT06431425 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the eCG Family Clinic, a virtual platform designed to provide genetic counseling for relatives of individuals diagnosed with inherited cardiovascular conditions. The trial compares the eCG Family Clinic's approach to traditional genetic counseling methods, aiming to increase participation rates among at-risk relatives. Participants will receive tailored information, the option for at-home DNA testing, and referrals for local cardiac monitoring if necessary. The study involves probands, at-risk relatives, and genetic healthcare professionals in a non-inferiority randomized controlled trial design.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are first or second-degree relatives of individuals diagnosed with inherited hypertrophic cardiomyopathy or dilated cardiomyopathy.
Not a fit: Patients who lack proficiency in the Dutch language or digital skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve access to genetic counseling and monitoring for individuals at risk of inherited cardiac diseases.
How similar studies have performed: Other studies have shown success with virtual health interventions, suggesting that this approach may be effective in increasing genetic counseling uptake.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Probands: * \> 18 y/o * Diagnosed with inherited hypertrophic cardiomyopathy (HCM) or dialted cardiomyopathy (DCM)) * Class 4 or 5 variant identified. * Access to a working laptop or computer device. At risk relatives: * \> 18 y/o * First degree family member, or second degree in case of a deceased first degree relative * Access to a working laptop or computer device. Healthcare professionals: \- Genetic counsellors of the genetics department directly involved in the care given to the family. Exclusion Criteria: \- Insufficient control of the Dutch language or digital skills.
Where this trial is running
Utrecht, Utrecht
- University Medical Centre Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marlies van Lingen, MSc.
- Email: m.n.vanlingen@umcutrecht.nl
- Phone: +31887553745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.