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NCT03395366 · ClinicalTrials.gov registry record · NA
Improving Outcomes for Hemodialysis Patients
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03395366: Completed NA study, sponsored by Columbia University.
NCT03395366 is a NA study that has completed, run by Columbia University. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395366, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately 400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and emotional toll on patients, and most patients on hemodialysis describe poor quality of life. Patients on hemodialysis have worse health related quality of life (HrQOL) than patients with any other chronic illness including cancer and congestive heart failure. This poor quality of life can affect how well these patients manage their own health or their self-care, and can ultimately lead to poor health outcomes. Despite this, there are no commonly used programs to improve quality of life or self-care for patients on hemodialysis. The investigators have developed a simple 3-step program to improve quality of life and self-care for patients on hemodialysis. The first step involves presenting quality of life scores to the dialysis health care team so that a program can be designed. The second step involves 8-12 education sessions combined with behavioral training designed to improve quality of life and self-care. The final step is monthly re-evaluation of progress. In this study, the investigators will test this 3-step program, compared to dialysis education alone, to see if it improves quality of life and self-care. By improving quality of life and self-care the investigators believe patient outcomes including hospitalizations will improve.
Primary Outcome
The investigators will summarize the average changes from pre to post for each treatment arm via means (±SD) and 95% confidence intervals and estimate the effect of our intervention by estimating a linear model for each post-treatment score, adjusting for pre-treatment score and treatment arm (i.e. an ANCOVA model).
Interventions
- OTHER Multifaceted Educational / Cognitive Behavioral Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-04-28 |
| Phase | NA |
What the finished NCT03395366 record still lists
NCT03395366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Multifaceted Educational / Cognitive Behavioral Intervention is the first listed.
NCT03395366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03395366 about?
NCT03395366 is a clinical study titled "Improving Outcomes for Hemodialysis Patients". End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately 400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and emotional toll on patients, and most patients on hemodialysis describe poor quality of life. Patients on hemodialysis ha...
What is the current status of trial NCT03395366?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-05-01. Estimated completion is 2020-04-28.
What interventions are being tested in trial NCT03395366?
The interventions under investigation include: Multifaceted Educational / Cognitive Behavioral Intervention (OTHER).
Who is sponsoring clinical trial NCT03395366?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03395366's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 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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