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Genetic Counseling Sequence for Heart Disease (RESEQUENCEGC Trial)

N/A

Waitlist Available

Led By Cynthia James

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis or suspected clinical diagnosis of a potentially inherited cardiovascular disease including hypertrophic, dilated, or arrhythmogenic cardiomyopathy, ventricular or atrial arrhythmias, or an ECG-pattern suspicious for an inherited cardiovascular disease including catecholaminergic polymorphic ventricular tachycardia, long QT syndrome, or Brugada syndrome, or a diagnosed or suspected lipid disorder or early-onset coronary artery disease

Documented pathogenic or likely pathogenic variant in a gene associated with a hereditary cardiomyopathy, arrhythmia syndrome, or lipid disease in a family member

Must not have

Previous genetic testing that definitively identified the genetic cause of the patient's condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post results disclosure

Awards & highlights

No Placebo-Only Group

Summary

This trialwill test whether tailored pre-test genetic counseling followed by post-test counseling increases efficiency and improves outcomes for those seeking genetic testing for medical management.

Who is the study for?

Adults over 18 with suspected or diagnosed inherited heart conditions, including various cardiomyopathies, arrhythmias, lipid disorders, or early-onset coronary artery disease. They must be scheduled for genetic counseling at the Johns Hopkins Center and have not had previous genetic counseling/testing for their condition there.

What is being tested?

The trial is testing a new approach to cardiovascular genetic counseling by providing pre-test education via video and post-test counseling sessions. It compares usual care with two other methods: one where a call with a counselor before testing is optional and another where it's required.

What are the potential side effects?

This study does not involve medication; therefore, traditional side effects are not applicable. However, participants may experience psychological impacts from learning about their genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I may have a genetic heart condition or early heart disease.

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A family member has a genetic heart or lipid condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition's genetic cause has been identified through testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post results disclosure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post results disclosure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post results disclosure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety as measured on the Hospital Anxiety and Depression Scale (HADS)

Change in empowerment as measured on the Genetic Counseling Outcomes Scale (GCOS)

Efficiency as assessed by minutes of counseling time

+1 more

Secondary study objectives

Change in engagement as assessed by Patient Activation Measure

Informed Choice as assessed by Multidimensional Model of informed Choice pilot scales

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: FlippedExperimental Treatment2 Interventions

Pre-test genetics education by educational video with a REQUIRED call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.

Group II: EfficiencyExperimental Treatment2 Interventions

Pre-test genetics education by educational video with an OPTIONAL call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.

Group III: Standard of careActive Control1 Intervention

Pre-test genetic counseling appointment with results returned by phone or EHR. Post-test appointment available upon request.

0 / 3Eligibility criteria met