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System Interventions to Achieve Early and Equitable Transplants Study - Long-Term

System Interventions to Achieve Early and Equitable Transplants (STEPS) Study (and Long-Term STEPS-LT)

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07515794
Acronym
STEPS-LT
Enrollment
793
Registered
2026-04-07
Start date
2026-06-11
Completion date
2029-12-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Kidney transplant, Living donor kidney transplant

Brief summary

STEPS-LT is an extension of the System Interventions to Achieve Early and Equitable Transplants (STEPS) study. STEPS-LT will follow participants that previously completed the STEPS study to evaluate sustained behavioral activation and transplant-related milestones among participants.

Detailed description

STEPS-LT extends the original STEPS study for long-term follow-up. Participants will be followed for an additional 36 months to evaluate sustained behavioral activation and transplant-related milestones among participants originally enrolled in STEPS. STEPS-LT maintains the original STEPS study cohort and will collect additional outcomes data through questionnaires, electronic health records, and the Scientific Registry of Transplant Recipients. This extended follow-up will assess participants' engagement in transplant readiness behaviors and transplant barriers they encounter over time.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
Geisinger Clinic
CollaboratorOTHER
University of Mississippi Medical Center
CollaboratorOTHER
Duke Health
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\- STEPS study participants who did not withdraw consent during the study or have not died.

Exclusion criteria

\- Not previously enrolled in STEPS study

Design outcomes

Primary

MeasureTime frameDescription
Patient Reported Physician Discussionsmonth 6, months 12, months 18, month 24, month 30, month 36number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient Reported Family Discussionsmonth 6, months 12, months 18, month 24, month 30, month 36number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient Reported Initiation of Transplant Evaluationmonth 6, months 12, months 18, month 24, month 30, month 36number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient Reported Identification of a Living Donormonth 6, months 12, months 18, month 24, month 30, month 36Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Patient Reported Completion of Transplant Evaluationmonth 6, months 12, months 18, month 24, month 30, month 36Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

Secondary

MeasureTime frameDescription
Health System Reported Live Donor Inquires to Transplant Centermonth 6, months 12, months 18, month 24, month 30, month 36the number of participants that made an inquiry to the transplant center related to donors as reported in health system electronic health record or questionnaires
Health System Reported Receipt of Live Donor Kidney Transplantmonth 6, months 12, months 18, month 24, month 30, month 36The number of participants that completed their live kidney donor transplant as reported by the electronic health record or questionnaire
Health System Reported Receipt of Deceased Donor Kidney Transplantmonth 6, months 12, months 18, month 24, month 30, month 36The number of participants that completed their deceased kidney donor transplant as reported by the electronic health record or questionnaire
Health System Reported Placement on Deceased Kidney Donor Waitlistmonth 6, months 12, months 18, month 24, month 30, month 36The number of participants that have been placed on the deceased kidney donor waitlist as reported in the electronic health record or United Network of Organ Sharing
Health System Reported Completion of Transplant Evaluationmonth 6, months 12, months 18, month 24, month 30, month 36Number of participants that said "yes" to completion of transplant evaluation as reported in health system electronic health record and administrative reports
Health System Reported Initiation of Transplant Evaluationmonth 6, months 12, months 18, month 24, month 30, month 36Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system electronic health record and administrative reports
Patient Reported Kidney Transplant Knowledgemonth 6, months 12, months 18, month 24, month 30, month 36Number of questions patients correctly answer measured by patient report in questionnaire

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREbony Boulware, M.D.

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026