1168 Participants Needed

STEPS Intervention for Kidney Disease

Recruiting at 1 trial location
CB
TS
CB
Overseen ByCassandra Bowman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.

Who Is on the Research Team?

EB

Ebony Boulware, M.D.

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and agree to the study's details verbally.
English speaking with adequate ability to hear and understand questions over the phone
I have chronic kidney disease with specific test results showing reduced kidney function.
See 1 more

Exclusion Criteria

You are no longer alive.
I am currently on dialysis.
You cannot hear or understand spoken words.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

STEPS Surveillance

A program to identify people who may need a kidney transplant and find people in health systems who may be able to receive kidney transplants early in their care

18 months

STEPS Outreach

Transplant social workers and coordinators focus on equality and patient needs to improve access to kidney transplants

18 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • STEPS Health System Outreach intervention
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Geisinger Clinic

Collaborator

Trials
159
Recruited
1,976,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Northwell Health

Collaborator

Trials
481
Recruited
470,000+

University of Mississippi Medical Center

Collaborator

Trials
185
Recruited
200,000+
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