NCT06455384 The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services
| NCT ID | NCT06455384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | Cardiac Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2025-10-28 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results. We have previously developed and tested an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) to be used for genetic testing decision making, and have now developed the Genetics Navigator (GN), a patient-centred e-health navigation platform for end-to-end genetic service delivery. The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered genetic testing. Results of this trial will be used to establish whether the GN is effective to use in practice. If effective, GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse of services. These are concerns policy makers seek to address through the triple aims of health care1. This study represents a significant advance in personalized health by assessing the effectiveness of this novel, comprehensive e-health platform to ultimately improve genetic service delivery, accessibility, patient experiences, and patient outcomes.
Eligibility Criteria
Inclusion: * Adult patients (18 years of age or older) who are referred to participating clinicians at Mount Sinai Hospital for clinical genetic testing. * Parents/legal guardians (18 years of age or older) of pediatric patients who are referred to participating clinicians at SickKids for clinical genetic testing. Exclusion: * Known not to be eligible for clinical genetic testing in Ontario * Requires urgent clinical genetic testing or prenatal genetic testing * Not fluent in English (speaking and reading)
Contact & Investigator
Yvonne Bombard, PhD
PRINCIPAL INVESTIGATOR
St. Michael's Hospital and University of Toronto
Frequently Asked Questions
Who can join the NCT06455384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455384 currently recruiting?
Yes, NCT06455384 is actively recruiting participants. Contact the research team at Marc.Clausen@unityhealth.to for enrollment information.
Where is the NCT06455384 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT06455384 clinical trial?
NCT06455384 is sponsored by Unity Health Toronto. The principal investigator is Yvonne Bombard, PhD at St. Michael's Hospital and University of Toronto. The trial plans to enroll 170 participants.