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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post results disclosure

Awards & highlights

RESEQUENCEGC Trial 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.Check my eligibility

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.See study design

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.

RESEQUENCEGC Trial 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.

RESEQUENCEGC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in engagement as assessed by Patient Activation Measure

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

RESEQUENCEGC 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

283,622 Total Patients Enrolled

4 Trials studying Genetic Counseling

1,195 Patients Enrolled for Genetic Counseling

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,561 Total Patients Enrolled

Cynthia JamesPrincipal InvestigatorJohns Hopkins University

Media Library

optional phone call with genetic counselor pre-test Clinical Trial Eligibility Overview. Trial Name: NCT05422573 — N/A

Genetic Counseling Research Study Groups: Efficiency, Standard of care, Flipped

Genetic Counseling Clinical Trial 2023: optional phone call with genetic counselor pre-test Highlights & Side Effects. Trial Name: NCT05422573 — N/A

optional phone call with genetic counselor pre-test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422573 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to take part in this clinical trial?

"Information on clinicaltrials.gov attests that this research is no longer seeking patients, as the study was first posted in December 12th 2022 and last updated in December 7th 2022. Nonetheless, there are currently 322 other medical trials searching for candidates to enroll."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing

2022. "Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422573.