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NCT01623583 · ClinicalTrials.gov registry record · Phase 4
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
A Phase 4 study, sponsored by Davita Clinical Research.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT01623583: Clinical Trial Phase 4 study, sponsored by Davita Clinical Research.
NCT01623583 is a Phase 4 study that was terminated before completion, run by Davita Clinical Research. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623583, a Phase 4 study, was terminated before completion, sponsored by Davita Clinical Research.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.
Primary Outcome
The primary outcome measure is how many patients progress from a score of 1 or 2 on the questionnaire (precontemplation or contemplation) as measured before the intervention to a score of 3 or 4 (planning or action) after the intervention, and it is measured one week after the intervention.
Interventions
- OTHER Enhanced Needle Phobia Intervention
- OTHER Standard Needle Phobia Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
Why NCT01623583 stopped before completion
NCT01623583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Enhanced Needle Phobia Intervention is the first listed.
NCT01623583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01623583 about?
NCT01623583 is a clinical study titled "Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias". An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access...
What is the current status of trial NCT01623583?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2014-04. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01623583?
The interventions under investigation include: Enhanced Needle Phobia Intervention (OTHER), Standard Needle Phobia Intervention (OTHER).
Who is sponsoring clinical trial NCT01623583?
This trial is sponsored by Davita Clinical Research, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01623583's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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