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NCT04520984 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.
A Early Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 45
- Enrollment target
NCT04520984: Completed Early Phase 1 study, sponsored by NYU Langone Health.
NCT04520984 is a Early Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 45 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04520984, a Early Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes. This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidney disease patients and to look for trends in impact over a 12-week follow-up period. Measurements will be taken at time one (time of enrollment) and time two (12 weeks). Our central hypothesis is that integration of palliative care with standard nephrology care in the ambulatory care of patients with a glomerular filtration rate (eGFR) ≤15ml/min/1.73m2 will trend towards improved symptom control, quality of life, and increased documentation of advance care planning when compared to usual nephrology care. We expect 10-15 patients per arm.
Primary Outcome
IPOS-Renal is a short measure (11 questions), combining the most common symptoms renal patients experience plus additional items from IPOS on concerns beyond symptoms, such as information needs, practical issues, family anxiety. The total score reflects symptom burden and can range from zero to 68, where 0 is least symptom burden and 68 is highest symptom burden.
Interventions
- OTHER Integrated ambulatory palliative and nephrology care
- OTHER Standard nephrology care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-07-12 |
| Est. Completion | 2021-04-26 |
| Phase | Early Phase 1 |
What the finished NCT04520984 record still lists
NCT04520984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Integrated ambulatory palliative and nephrology care is the first listed.
NCT04520984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04520984 about?
NCT04520984 is a clinical study titled "Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.". The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes. This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidn...
What is the current status of trial NCT04520984?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2020-07-12. Estimated completion is 2021-04-26.
What interventions are being tested in trial NCT04520984?
The interventions under investigation include: Integrated ambulatory palliative and nephrology care (OTHER), Standard nephrology care (OTHER).
Who is sponsoring clinical trial NCT04520984?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04520984's enrollment target sits among peer trials
45 575th of 2000 higher than 1,413 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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