Improving Access to Renal Transplantation for Underserved Black Communities

Not Applicable

Withdrawn

• Conditions: Kidney Transplant; ESRD (End Stage Renal Disease)

• Registration Number: NCT06707038
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-27
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-06
• Study Completion: 2025-05-06
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Listing status for each Arm by month 12	12 months from time of enrollment	Listing (active or inactive) status by month 12

Secondary Outcome Measures

Name	Time	Method
Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale	at enrollment and at 12 months after enrollment	Scoring/T-Score Metric: The T-score metric is standardized with a mean of 50 and a standard deviation (SD) of 10. This means a T-score of 50 represents the average score of the reference population, and each 10-point deviation represents one standard deviation above or below the mean.; Minimum and Maximum Values: The T-score typically ranges from 20 to 80, though this can vary slightly depending on the specific population and scoring method used.; Interpretation: Higher T-scores indicate better health outcomes, while lower T-scores indicate worse health outcomes.
Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)	at enrollment and at 12 months after enrollment	Scoring: The PKDSMS uses an average score on a five-point Likert scale, where respondents rate their self-management abilities.; Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low self-efficacy and 5 indicating high self-efficacy.; Interpretation: Higher scores indicate better self-management and higher confidence in managing kidney dialysis.
trust in care received by transplant team using Adapted Trust in Physicians Scale	at enrollment and at 12 months after enrollment	Scoring: This scale typically uses a five-point Likert format, where respondents rate their level of agreement with various statements about their trust in their physicians. The response options range from "strongly disagree" to "strongly agree".; Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low trust and 5 indicating high trust.; Interpretation: Higher scores indicate greater trust in the transplant team, while lower scores indicate less trust.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States