Improving Access to Renal Transplantation for Underserved Black Communities
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Listing status for each Arm by month 12
研究概览
简要总结
The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are:
Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team?
Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- 否
入选标准
- •self-identify as Black or African American;
- •18 to 75 years of age
- •have an eGFR < 20 or End Stage Renal Disease Diagnosis;
- •screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns);
- •medically eligible to begin transplant evaluation process determined by transplant team
排除标准
- •other racial groups
- •participants who have previously received a transplant;
- •pregnant women;
- •participants who screen negative on the screener;
- •children less than 18 years old
研究组 & 干预措施
AATAP (intervention) Arm
One clinic visit with all transplant providers, racially concordant care team, dedicated social worked. This will incorporate: Cultural congruency, trust, health literacy and psychological support. Questionnaires also to be administered
干预措施: AATAP intervention (Behavioral)
Standard of Care (Control) Arm
Separate visits with nephologist, surgeons and social worker. This arm will follow common standard of care at the site. Questionnaires also to be administered
结局指标
主要结局
Listing status for each Arm by month 12
时间窗: 12 months from time of enrollment
Listing (active or inactive) status by month 12
次要结局
- Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale(at enrollment and at 12 months after enrollment)
- Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)(at enrollment and at 12 months after enrollment)
- trust in care received by transplant team using Adapted Trust in Physicians Scale(at enrollment and at 12 months after enrollment)
研究者
Daniela Ladner
Director, Northwestern University Transplant Outcomes Collaborative
Northwestern University