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NCT06378476 · ClinicalTrials.gov registry record · NA
Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment
A NA study of Chronic Kidney Diseases and Trauma, Psychological, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 153
- Enrollment target
- 1
- Study location
NCT06378476: Completed NA study of Chronic Kidney Diseases and Trauma, Psychological, sponsored by University of Pennsylvania.
NCT06378476 is a NA study of Chronic Kidney Diseases and Trauma, Psychological that has completed, run by University of Pennsylvania. The registered enrollment target is 153 participants, below the 443-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06378476, a NA study of Chronic Kidney Diseases and Trauma, Psychological, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 153 participants
- Enrollment target
- 1
- Study location
Study Summary
Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences.
Primary Outcome
KDQOL-36 is a short form that includes a generic score (the 12-Item Short Form Health Survey (SF-12), which includes the SF-12 Physical and Mental Component Summaries \[SF-12 PCS and MCS\]) and three CKD-specific subscales: 1) burden of kidney disease, 2) symptoms/problems of kidney disease, and 3) effects of kidney disease. Each of the KDQOL-36 kidney-targeted scales are scored by transforming all items linearly to a 0-100 possible range and averaging the items in the scale. On the KDQOL-36, hi
Conditions Studied
Interventions
- BEHAVIORAL IMPaCT Community Health Worker Program
- OTHER Trauma-Informed Care Training
Study Locations (1)
Pennsylvania
- Penn Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2025-11-26 |
| Phase | NA |
What the finished NCT06378476 record still lists
NCT06378476 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 443-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which IMPaCT Community Health Worker Program is the first listed.
NCT06378476 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06378476 about?
NCT06378476 is a clinical study titled "Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment". Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are ...
What is the current status of trial NCT06378476?
This trial is currently completed. It is a NA study. The enrollment target is 153 participants. The study started on 2024-06-17. Estimated completion is 2025-11-26.
What conditions does trial NCT06378476 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases, Trauma, Psychological, Racism, Systemic.
What interventions are being tested in trial NCT06378476?
The interventions under investigation include: IMPaCT Community Health Worker Program (BEHAVIORAL), Trauma-Informed Care Training (OTHER).
Who is sponsoring clinical trial NCT06378476?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06378476 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06378476's enrollment target sits among peer trials
153 32nd of 73 higher than 42 of 73 other Chronic Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Diseases 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.
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