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Behavioral Intervention
STEPS Intervention for Kidney Disease
N/A
Waitlist Available
Led By Ebony Boulware, M.D.
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to provide oral informed consent
Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
Must not have
Male or female, aged <18 or > 75 years
Patients on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will improve kidney care for everyone by reducing racial differences and increasing access to kidney transplants.
Who is the study for?
The STEPS study is for English-speaking adults aged 18 to 75 with chronic kidney disease (CKD), specifically those not on dialysis, without a prior kidney transplant, and not currently waitlisted for one. Participants must be able to hear and understand phone conversations and consent to the study's procedures.
What is being tested?
The trial tests a 'STEPS Health System Outreach' intervention aimed at reducing racial disparities in kidney care. It includes identifying patients early who may need transplants and comparing the effectiveness of an outreach program against usual care in improving access to transplants.
What are the potential side effects?
Since this trial focuses on health system interventions rather than medications or medical procedures, traditional side effects are not applicable. However, participants may experience changes related to their engagement with healthcare professionals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and agree to the study's details verbally.
Select...
I have chronic kidney disease with specific test results showing reduced kidney function.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am younger than 18 or older than 75.
Select...
I am currently on dialysis.
Select...
I have had a kidney transplant.
Select...
I am currently receiving hospice or palliative care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Health system reported completion of transplant evaluation
Secondary study objectives
Deceased kidney donor transplants
Health system reported initiation of transplant evaluation
Live donor inquires to transplant center
+9 moreAwards & 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: STEPS Health System Surveillance and Outreach interventionExperimental Treatment1 Intervention
Group II: Usual Kidney CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,330,664 Total Patients Enrolled
Geisinger ClinicOTHER
154 Previous Clinical Trials
1,977,518 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,077,791 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and agree to the study's details verbally.I am younger than 18 or older than 75.You are no longer alive.I am currently on dialysis.You cannot hear or understand spoken words.I have had a kidney transplant.I am currently receiving hospice or palliative care.I have chronic kidney disease with specific test results showing reduced kidney function.I am between 18 and 75 years old.You have a life-threatening illness or are receiving hospice care.You are currently on the waiting list for an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: STEPS Health System Surveillance and Outreach intervention
- Group 2: Usual Kidney 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.
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