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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 below
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I can understand and agree to the study's details verbally.
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I have chronic kidney disease with specific test results showing reduced kidney function.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 or older than 75.
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I am currently on dialysis.
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I have had a kidney transplant.
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I am currently receiving hospice or palliative care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 more

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: 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
2,455 Previous Clinical Trials
4,333,940 Total Patients Enrolled
Geisinger ClinicOTHER
155 Previous Clinical Trials
1,977,530 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,078,519 Total Patients Enrolled
Northwell HealthOTHER
474 Previous Clinical Trials
467,966 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,397 Previous Clinical Trials
2,458,961 Total Patients Enrolled
University of Mississippi Medical CenterOTHER
180 Previous Clinical Trials
195,723 Total Patients Enrolled
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,968,281 Total Patients Enrolled
Ebony Boulware, M.D.Principal InvestigatorWake Forest University Health Sciences

Media Library

STEPS Health System Outreach intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05014256 — N/A
Chronic Kidney Disease Research Study Groups: STEPS Health System Surveillance and Outreach intervention, Usual Kidney Care
Chronic Kidney Disease Clinical Trial 2023: STEPS Health System Outreach intervention Highlights & Side Effects. Trial Name: NCT05014256 — N/A
STEPS Health System Outreach intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014256 — N/A
~319 spots leftby Dec 2025
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