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NCT06077201 · ClinicalTrials.gov registry record · NA
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
A NA study of Valvular Heart Disease, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 375
- Enrollment target
- 1
- Study location
NCT06077201: Recruiting NA study of Valvular Heart Disease, sponsored by Vanderbilt University Medical Center.
NCT06077201 is a NA study of Valvular Heart Disease that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 375 participants, below the 1,135-participant average among 8 other Valvular Heart Disease trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06077201, a NA study of Valvular Heart Disease, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 375 participants
- Enrollment target
- 1
- Study location
Study Summary
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.
Primary Outcome
The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death; (2) all-cause hospitalization; and (3) skilled nursing facility visits. To examine whether the intervention improves mortality, hospitalization, and SNF rates after THVIs, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The pooled active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the avera
Conditions Studied
Interventions
- OTHER HBCR hands-off
- OTHER HBCR interactive
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2026-10-01 |
| Phase | NA |
What NCT06077201 shows while recruiting
NCT06077201 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 1,135-participant average among 8 other Valvular Heart Disease trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Valvular Heart Disease appearing as the primary indexed condition, and to 2 interventions - of which HBCR hands-off is the first listed.
NCT06077201 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06077201 about?
NCT06077201 is a clinical study titled "Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions". The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is e...
What is the current status of trial NCT06077201?
This trial is currently recruiting. It is a NA study. The enrollment target is 375 participants. The study started on 2023-12-15. Estimated completion is 2026-10-01.
What conditions does trial NCT06077201 study?
This clinical trial studies the following conditions: Valvular Heart Disease.
What interventions are being tested in trial NCT06077201?
The interventions under investigation include: HBCR hands-off (OTHER), HBCR interactive (OTHER).
Who is sponsoring clinical trial NCT06077201?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06077201 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06077201's enrollment target sits among peer trials
375 7th of 8 higher than 2 of 8 other Valvular Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Valvular Heart Disease 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.
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