Clinical trial NCT06707038: Improving Access to Renal Transplantation for Underserved Black Communities
Official title: Improving Access to Renal Transplantation for Underserved Black Communities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Transplant
ESRD (End Stage Renal Disease)
Keywords: Heath Services Research
Intervention
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Tampa General Hospital
First posted: 2024-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will use a 1:1 allocation ratio of randomization to intervention and control. Randomization will be stratified by sex (male, female) and age (divided into 2 categories). Participants will be assigned to a randomization group upon completing the eligibility screener and consent has been obtained, which will occur after the patient has attended the Roundtable visit and completed baseline questionnaires, but before their first visit with the center.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Listing status for each Arm by month 12
timeFrame: 12 months from time of enrollment
Secondary outcomes:
measure: Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale
timeFrame: at enrollment and at 12 months after enrollment
measure: Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
timeFrame: at enrollment and at 12 months after enrollment
measure: trust in care received by transplant team using Adapted Trust in Physicians Scale
timeFrame: at enrollment and at 12 months after enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Northwestern University
name: Daniela Ladner, MD, MPH, FACS, FAST
role: PRINCIPAL_INVESTIGATOR
References: