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A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
NCT05805709 · View on ClinicalTrials.gov ↗
Study Summary
The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
Conditions Studied
Interventions
- OTHER Patient Education
- OTHER Study Physician/Advance Practice Provider
- OTHER Nurse Navigator
- OTHER Pharmacist
Study Locations (9)
Maryland
- University of Maryland — Baltimore
- Johns Hopkins University — Baltimore
Ohio
- MetroHealth — Cleveland
- Cleveland Clinic Foundation — Cleveland
Tennessee
- Nashville VA Medical Center — Nashville
- Vanderbilt University — Nashville
Alabama
- University of Alabama at Birmingham — Birmingham
Connecticut
- Yale University — New Haven
Florida
- Cleveland Clinic Weston Hospital — Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,145 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2027-03-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05805709
The ClinicalTrials.gov registry entry for NCT05805709 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 4 interventions — of which Patient Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05805709 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Maryland, Ohio, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05805709 about?
NCT05805709 is a clinical study titled "A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial". The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free da...
What is the current status of trial NCT05805709?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,145 participants. The study started on 2023-09-05. Estimated completion is 2027-03-05.
What conditions does trial NCT05805709 study?
This clinical trial studies the following conditions: Acute Kidney Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05805709?
The interventions under investigation include: Patient Education (OTHER), Study Physician/Advance Practice Provider (OTHER), Nurse Navigator (OTHER), Pharmacist (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05805709?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05805709 being conducted?
This trial has 9 study locations across Alabama, Connecticut, Florida, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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