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NCT04392440 · ClinicalTrials.gov registry record · NA
Shared Decision Making in Dialysis
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
NCT04392440: Completed NA study, sponsored by University of Rochester.
NCT04392440 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04392440, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
Study Summary
Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. Older patients with CKD often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. Shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. The proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. Nephrologists in the Intervention Group will receive 3 communication training sessions, delivered by a standardized patient instructor (SPI) who enact clinical scenarios and offer feedback. In parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. Nephrologists in the Control Group will provide their patients with usual care. The study outcomes will be assessed during two nephrology office visits and at 6 months.
Primary Outcome
Feasibility was assessed using a structured questionnaire that asked participants whether the coaching, question prompt list, booklet, and videos seemed possible, doable, easy to use, and able to be carried out in practice. Each item was rated on a scale from 1 ("completely disagree") to 5 ("completely agree"). Item scores were summed for each participant to create a total feasibility score, ranging from a minimum of 4 to a maximum of 20, with higher scores indicating greater feasibility. Assess
Interventions
- OTHER usual care
- BEHAVIORAL DIAL-SDM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2024-05-14 |
| Phase | NA |
What the finished NCT04392440 record still lists
NCT04392440 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT04392440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04392440 about?
NCT04392440 is a clinical study titled "Shared Decision Making in Dialysis". Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. O...
What is the current status of trial NCT04392440?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2022-02-28. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT04392440?
The interventions under investigation include: usual care (OTHER), DIAL-SDM (BEHAVIORAL).
Who is sponsoring clinical trial NCT04392440?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04392440's enrollment target sits among peer trials
102 837th of 2000 higher than 1,161 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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