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Behavioral Intervention

Access Program for Kidney Transplant (AATAP Trial)

Tampa, FL

Phase 2

Waitlist Available

Led By Daniela Ladner, MD, MPH, FACS, FAST

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 75 years of age

Have an eGFR < 20 or End Stage Renal Disease Diagnosis

Must not have

Children less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months from time of enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a program called the African American Transplant Access Program can be successfully used in a different kidney transplant program. They want to know if this program helps increase the number of Black

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Who is the study for?

This trial is for Black individuals with kidney failure who are potential candidates for a kidney transplant. The study aims to see if the African American Transplant Access Program (AATAP) helps more Black patients get on the transplant list, and if it boosts their confidence and trust in their healthcare team.Check my eligibility

What is being tested?

The trial is testing the effectiveness of AATAP by comparing two groups: one receiving the AATAP intervention and another getting usual care. After 12 months, researchers will check if there's an increase in the number of patients listed for a kidney transplant among those who participated in AATAP.See study design

What are the potential side effects?

Since this trial involves a therapeutic intervention rather than medication, traditional side effects like you might expect from drugs aren't applicable here. However, participants may experience changes in emotions or attitudes due to increased engagement with healthcare processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My kidney function is very low or I have end-stage kidney disease.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months from time of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months from time of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months from time of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Listing status for each Arm by month 12

Secondary study objectives

Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale

Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

trust in care received by transplant team using Adapted Trust in Physicians Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AATAP (intervention) ArmExperimental Treatment1 Intervention

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

Group II: Standard of Care (Control) ArmActive Control1 Intervention

Separate visits with nephologist, surgeons and social worker. This arm will follow common standard of care at the site. Questionnaires also to be administered

0 / 3Eligibility criteria met