A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE… (NCT05805709) | Clinical Trial Compass
RecruitingNot Applicable
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
United States2,145 participantsStarted 2023-09-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥ 18 years
. Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements \>12 hours apart)
Exclusion criteria
. AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on a 'process-of-care' intervention for AKI patients in the hospital — can you explain what that actually means in practice, and how it would change the care I receive compared to standard treatment?
2The main thing this trial is measuring is 'hospital-free days' over 90 days, meaning how much time I spend out of the hospital — does that feel like the right goal for my specific situation, or are there other outcomes I should be prioritizing right now?
3Since this trial is listed as 'Phase NA,' it sounds like it's testing a care process rather than a new drug — does that mean the safety profile is different from a typical drug trial, and what risks, if any, should I still be aware of?
4Given that I'm currently hospitalized with AKI, how does enrolling in this trial compare to just receiving the best standard care available, and is there a real difference in what I'd receive day-to-day?
5What happens to my follow-up care after I leave the hospital if I join this trial — would I need to come back for check-ins over those 90 days, and is that realistic given my situation at home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.