ESRD (End Stage Renal Disease), Kidney Transplant
Conditions
Keywords
Heath Services Research, Intervention
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.
Interventions
BEHAVIORALAATAP intervention
AATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tampa General Hospital
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Listing status for each Arm by month 12 | 12 months from time of enrollment | Listing (active or inactive) status by month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed