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NCT05422573 · ClinicalTrials.gov registry record · NA
Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing
A NA study, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 393
- Enrollment target
NCT05422573: Active NA study, sponsored by Johns Hopkins University.
NCT05422573 is a NA study that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 393 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422573, a NA study, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 393 participants
- Enrollment target
Study Summary
Although pre-test genetic counseling is widely recommended and has come to dominate genetic counseling practice, tailored results-focused genetic counseling could both increase genetic counseling efficiency and improve genetic counseling outcomes for the growing number of patients seeking genetic testing for recommended genome-guided medical management. This study will test that hypothesis in adults referred for cardiovascular genetic counseling and testing at the Johns Hopkins Center for Inherited Heart Diseases. This study is a three-arm randomized clinical trial to evaluate two complementary approaches to shifting the primary genetic counseling session to post-test for 510 adults with two broad cardiovascular genetic counseling indications: diagnostic panel testing and family-specific variant testing. The investigators will compare usual care (pre-test genetic counseling appointment, results returned by phone / electronic health record) with online video-based pre-test tailored genetic education with an optional (efficiency arm) or required (flipped arm) phone call with a genetic counselor followed by a post-test genetic counseling appointment. The investigators hypothesize that post-test genetic counseling will: 1) increase efficiency, 2) promote patient empowerment and adherence, and 3) have similar genetic test-associated psychosocial impact.
Primary Outcome
Change in empowerment as measured on the Genetic Counseling Outcomes Scale (GCOS). The GCOS is 24-item Likert scale with a 7-item response set. Scores range from 24-168 with higher scores indicating higher empowerment.
Interventions
- BEHAVIORAL post-test cardiovascular genetic counseling with pre-test education by video
- BEHAVIORAL required phone call with genetic counselor pre-test
- BEHAVIORAL optional phone call with genetic counselor pre-test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT05422573 still lists
NCT05422573 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which post-test cardiovascular genetic counseling with pre-test education by video is the first listed.
NCT05422573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05422573 about?
NCT05422573 is a clinical study titled "Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing". Although pre-test genetic counseling is widely recommended and has come to dominate genetic counseling practice, tailored results-focused genetic counseling could both increase genetic counseling efficiency and improve genetic counseling outcomes for the growing number of patients seeking genetic te...
What is the current status of trial NCT05422573?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 393 participants. The study started on 2022-12-20. Estimated completion is 2026-06-30.
What interventions are being tested in trial NCT05422573?
The interventions under investigation include: post-test cardiovascular genetic counseling with pre-test education by video (BEHAVIORAL), required phone call with genetic counselor pre-test (BEHAVIORAL), optional phone call with genetic counselor pre-test (BEHAVIORAL).
Who is sponsoring clinical trial NCT05422573?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05422573's enrollment target sits among peer trials
393 269th of 2000 higher than 1,732 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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