Your session is about to expire
← Back to Search
Patient-centered Care for Acute Kidney Injury (COPE-AKI Trial)
N/A
Recruiting
Led By Kaleab Abebe, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
COPE-AKI Trial Summary
This trial will compare a new intervention to usual care to see if it helps people avoid hospital visits for up to 90 days. It will test how it affects kidney health and patient reported outcomes. 2145 people will be randomly assigned to the study.
Who is the study for?
The COPE-AKI trial is for adults over 18 with severe acute kidney injury (AKI) that's lasted at least two days. It's not for those with certain types of kidney diseases, end-stage kidney disease, serious lung or liver conditions, life expectancy under six months, pregnancy, cognitive impairment preventing consent, or if they're in another high-risk study.Check my eligibility
What is being tested?
This study compares a special care package including a doctor/advanced provider team-up, nurse navigator support, pharmacist involvement and patient education against the usual care given to AKI patients. The goal is to see if this approach increases the number of days patients stay out of the hospital after discharge.See study design
What are the potential side effects?
Since this trial focuses on process-of-care interventions rather than medications or medical procedures directly affecting health status, specific side effects are not anticipated as part of the intervention itself.
COPE-AKI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage 2 or 3 kidney injury that has lasted for more than 2 days.
COPE-AKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital-Free Days (HFDs) through day 90
Secondary outcome measures
Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 180 days.
Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 180 days.
Change from baseline in Interactions with Providers at 180 days.
+3 moreCOPE-AKI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Process of Care InterventionExperimental Treatment4 Interventions
A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review.
Group II: Usual CareActive Control1 Intervention
After receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,341,011 Total Patients Enrolled
10 Trials studying Acute Kidney Injury
84,302 Patients Enrolled for Acute Kidney Injury
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,312,447 Total Patients Enrolled
24 Trials studying Acute Kidney Injury
24,655 Patients Enrolled for Acute Kidney Injury
Kaleab Abebe, PhDPrincipal InvestigatorUniverisity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble thinking clearly, as shown by a test called the Brief Confusion Assessment Method (bCAM).I have been diagnosed with glomerulonephritis before or recently.I will still need dialysis after leaving the hospital.You have been referred to a kidney doctor in the last 6 months.I am 18 years old or older.I had a kidney removal surgery during my last hospital stay.My kidney function improved quickly after treating a blockage in my urinary system.My organs, except for my kidneys, are functioning well.I can participate in both in-person and remote visits.I have severe liver disease with a MELD score over 30 or have been diagnosed with hepatorenal syndrome.I do not have advanced lung disease like severe COPD, fibrosis, or cystic fibrosis.I am currently receiving treatment for kidney inflammation.People who live in an institution.I have received a kidney transplant in the past.My kidney injury is due to a specific type of kidney inflammation or blood vessel issue.I do not have a genetic disorder causing electrolyte imbalances.I have severe heart failure.I am being discharged to a specialized care facility or another hospital.I have been hospitalized for an organ or stem cell transplant.The research team decided I can't join based on my current health status at discharge.I have stage 2 or 3 kidney injury that has lasted for more than 2 days.Your kidney function is very low, with an estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m2.People who are in prison.I am on long-term dialysis.My main treatment goal is comfort, and I have been told I have less than 6 months to live.My kidneys have stopped working properly.I have cancer that has spread or needs treatment like chemo.
Research Study Groups:
This trial has the following groups:- Group 1: Multimodal Process of Care Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial being implemented in hospitals?
"At present, there are 7 sites that are conducting this trial. These locales span from New Haven to Cleveland and also encompass other cities as well. It might be sensible to pick the closest one so you can limit travel requirements if you do decide to participate."
Answered by AI
Are participants being enrolled in this research study at present?
"As per information on clinicaltrials.gov, this trial is no longer recruiting participants. Initially posted on May 1st 2023 and last modified March 27th the same year, it can be confirmed that there are over one hundred twenty other trials actively enlisting patients currently."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger