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Enrolling by Invitation

NCT Number: NCT07515794

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient Reported Physician Discussions

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

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

  2. Patient Reported Family Discussions

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

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

  3. Patient Reported Initiation of Transplant Evaluation

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

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

  4. Patient Reported Identification of a Living Donor

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

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

  5. Patient Reported Completion of Transplant Evaluation

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

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

Secondary outcomes

  1. Health System Reported Live Donor Inquires to Transplant Center

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    the number of participants that made an inquiry to the transplant center related to donors as reported in health system electronic health record or questionnaires

  2. Health System Reported Receipt of Live Donor Kidney Transplant

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    The number of participants that completed their live kidney donor transplant as reported by the electronic health record or questionnaire

  3. Health System Reported Receipt of Deceased Donor Kidney Transplant

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    The number of participants that completed their deceased kidney donor transplant as reported by the electronic health record or questionnaire

  4. Health System Reported Placement on Deceased Kidney Donor Waitlist

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    The 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

  5. Health System Reported Completion of Transplant Evaluation

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    Number of participants that said "yes" to completion of transplant evaluation as reported in health system electronic health record and administrative reports

  6. Health System Reported Initiation of Transplant Evaluation

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system electronic health record and administrative reports

  7. Patient Reported Kidney Transplant Knowledge

    Time frame: month 6, months 12, months 18, month 24, month 30, month 36

    Number of questions patients correctly answer measured by patient report in questionnaire

Other outcomes

  1. Patients that reported behavioral activation and subsequently received transplant

    Time frame: Up to year 3

    Number of patients who displayed treatment readiness behaviors and subsequently received transplant

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Duke Health
  • Geisinger Clinic
  • University of Mississippi Medical Center

Registry information

Official study title

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

Acronym: STEPS-LT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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