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NCT04755816 · ClinicalTrials.gov registry record · Phase 3
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
A Phase 3 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT04755816: Clinical Trial Phase 3 study, sponsored by University of Michigan.
NCT04755816 is a Phase 3 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04755816, a Phase 3 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
Primary Outcome
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the diet intervention with every participant not receiving the diet intervention within each stratum. Within each pairing, a +1 is assigned to the "better"
Interventions
- BEHAVIORAL Sodium intervention
- BEHAVIORAL Clinical worsening intervention
- BEHAVIORAL Educational content
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 3 |
Why NCT04755816 stopped before completion
NCT04755816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Sodium intervention is the first listed.
NCT04755816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04755816 about?
NCT04755816 is a clinical study titled "A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure". This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
What is the current status of trial NCT04755816?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2021-06-14. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT04755816?
The interventions under investigation include: Sodium intervention (BEHAVIORAL), Clinical worsening intervention (BEHAVIORAL), Educational content (BEHAVIORAL).
Who is sponsoring clinical trial NCT04755816?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04755816's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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