NCT07515794

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
793

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Dec 2029

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 11, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

March 31, 2026

Last Update Submit

July 2, 2026

Conditions

Chronic Kidney Diseases

Keywords

Kidney transplantLiving donor kidney transplant

Outcome Measures

Primary Outcomes (5)

  • Patient Reported Physician Discussions

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

    month 6, months 12, months 18, month 24, month 30, month 36

  • Patient Reported Family Discussions

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

    month 6, months 12, months 18, month 24, month 30, month 36

  • Patient Reported Initiation of Transplant Evaluation

    number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire

    month 6, months 12, months 18, month 24, month 30, month 36

  • Patient Reported Identification of a Living Donor

    Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire

    month 6, months 12, months 18, month 24, month 30, month 36

  • Patient Reported Completion of Transplant Evaluation

    Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

    month 6, months 12, months 18, month 24, month 30, month 36

Secondary Outcomes (7)

  • Health System Reported Live Donor Inquires to Transplant Center

    month 6, months 12, months 18, month 24, month 30, month 36

  • Health System Reported Receipt of Live Donor Kidney Transplant

    month 6, months 12, months 18, month 24, month 30, month 36

  • Health System Reported Receipt of Deceased Donor Kidney Transplant

    month 6, months 12, months 18, month 24, month 30, month 36

  • Health System Reported Placement on Deceased Kidney Donor Waitlist

    month 6, months 12, months 18, month 24, month 30, month 36

  • Health System Reported Completion of Transplant Evaluation

    month 6, months 12, months 18, month 24, month 30, month 36

  • +2 more secondary outcomes

Other Outcomes (1)

  • Patients that reported behavioral activation and subsequently received transplant

    Up to year 3

Study Arms (2)

STEPS Health Systems Surveillance and Outreach Intervention

Usual Kidney care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants previously enrolled in STEPS study will participate in this extension study (STEPS-LT).

You may qualify if:

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

You may not qualify if:

  • \- Not previously enrolled in STEPS study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ebony Boulware, M.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

June 11, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)