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Behavioral Intervention
Educational Program for Kidney Disease (CKD-EDU Trial)
N/A
Waitlist Available
Led By Fahad Saeed, MBBS, MSCI
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has not yet made a dialysis decision
Age ≥ 75 years old
Must not have
Has already decided on dialysis or active medical care without dialysis
Has already been seen by a Palliative Care (PC) clinician or is enrolled in hospice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up base line 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether an educational program called CKD-EDU can help older adults make better decisions about their kidney therapy and improve their well-being. They also want to see if this program can
Who is the study for?
This trial is for older adults with advanced chronic kidney disease. Participants should be interested in learning about their condition and treatment options to make better health decisions. Specific eligibility details are not provided, but typically, participants must meet certain health criteria.
What is being tested?
The study tests if an educational program (CKD-EDU) plus meetings with a palliative care specialist can help patients make more informed kidney therapy choices compared to usual nephrology care alone. The impact on emergency visits, hospital admissions, and end-of-life care quality will also be assessed.
What are the potential side effects?
Since the intervention involves education and consultation rather than medication or invasive procedures, significant side effects are not expected. However, emotional or psychological responses to discussions about end-of-life care may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not decided on starting dialysis.
Select...
I am 75 years old or older.
Select...
My kidney function is low, with an eGFR of 30 ml/min/1.73 m2 or less.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen either dialysis or active medical care without it.
Select...
I have seen a Palliative Care specialist or am enrolled in hospice.
Select...
I am currently receiving dialysis.
Select...
I am able to understand and consent to my treatment and can complete oral surveys.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 4-6 weeks
Secondary study objectives
Changes in number of hospital admissions, intensive care admissions, and emergency room visits
Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale
Differences in end-of-life care between intervention and control arm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Program BExperimental Treatment1 Intervention
Behavioral: CKD-EDU Palliative care-based decision-support intervention for support with kidney therapy decision-making
Group II: Program AActive Control1 Intervention
Kidney therapy education and support with kidney therapy decision-making.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Program B
2018
N/A
~190
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
871 Previous Clinical Trials
549,492 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,188 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,191,806 Total Patients Enrolled
Fahad Saeed, MBBS, MSCIPrincipal InvestigatorUniversity of Rochester