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Behavioral Intervention

STEPS Intervention for Kidney Disease

N/A
Recruiting
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health system reported completion of transplant evaluation
Secondary outcome measures
Deceased kidney donor transplants
Health system reported initiation of transplant evaluation
Live donor inquires to transplant center
+9 more

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
2,358 Previous Clinical Trials
4,313,924 Total Patients Enrolled
Geisinger ClinicOTHER
148 Previous Clinical Trials
1,884,943 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,995,798 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility requirement for this trial restricted to people aged 20 or older?

"The enrollment qualifications for this medical experiment demand that prospective participants are aged 18 or above and not older than 75."

Answered by AI

How many participants can be enrolled in this research endeavor?

"Affirmative. The details hosted on clinicaltrials.gov denote that this medical experiment, which was initially posted April 2nd 2022, is currently soliciting participants. Approximately 1150 patients need to be recruited from 1 trial location."

Answered by AI

Are there any eligibility requirements to participate in this clinical experiment?

"This clinical trial seeks 1150 patients, aged 18-75 with chronic kidney disease. Eligible participants must agree to comply with the study's guidelines and commit to its entirety; provide oral consent; possess adequate auditory capabilities in English; and have an eGFR lower than 30 or a KFRE higher than 10%."

Answered by AI

Are there any opportunities to join this medical research experiment at the present moment?

"Affirmative. According to records on clinicaltrials.gov, this medical research is now admitting subjects for participation in the study which was initially posted April 2nd 2022 and revised July 27th of the same year. 1150 volunteers must be recruited from a single site for data collection purposes."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Massachusetts
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
2022. "System Interventions to Achieve Early and Equitable Transplants (STEPS) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014256.
~164 spots leftby Aug 2024
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