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Enrolling by invitation NCT07515794

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

Observational Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Patient Reported Physician Discussions [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Patient Reported Family Discussions [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Patient Reported Initiation of Transplant Evaluation [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Patient Reported Identification of a Living Donor [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Patient Reported Completion of Transplant Evaluation [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
Secondary outcome measures (7)
  • Health System Reported Live Donor Inquires to Transplant Center [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Health System Reported Receipt of Live Donor Kidney Transplant [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Health System Reported Receipt of Deceased Donor Kidney Transplant [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Health System Reported Placement on Deceased Kidney Donor Waitlist [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Health System Reported Completion of Transplant Evaluation [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Health System Reported Initiation of Transplant Evaluation [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]
  • Patient Reported Kidney Transplant Knowledge [Time frame: month 6, months 12, months 18, month 24, month 30, month 36]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT07515794 · IRB00097407.1 · LTF-2024C2-39695

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗