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临床试验/NCT07515794
NCT07515794Enrolling By Invitation不适用

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

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 793 人开始时间: 2026年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
793
试验地点
1
主要终点
Patient Reported Physician Discussions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • - Not previously enrolled in STEPS study

结局指标

主要结局

Patient Reported Physician Discussions

时间窗: 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

Patient Reported Family Discussions

时间窗: 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

Patient Reported Initiation of Transplant Evaluation

时间窗: 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

Patient Reported Identification of a Living Donor

时间窗: 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

Patient Reported Completion of Transplant Evaluation

时间窗: 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

次要结局

  • 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)
  • Health System Reported Initiation of Transplant Evaluation(month 6, months 12, months 18, month 24, month 30, month 36)
  • Patient Reported Kidney Transplant Knowledge(month 6, months 12, months 18, month 24, month 30, month 36)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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