Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06655857

Interventions for Promoting Kidney Transplant Empowerment

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-01

5

Participants Needed

3

Research Sites

125 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).

CONDITIONS

Official Title

Interventions for Promoting Kidney Transplant Empowerment

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent from the patient.
  • Willingness to comply with all study procedures and be available for the duration of the study.
  • Age between 18 and 75 years.
  • Estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m2 or less, or on maintenance in-center hemodialysis.
  • Receiving kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or a participating hemodialysis center.
  • Living in the community (not in a nursing home or incarcerated).
  • Able to speak English and/or Spanish.
  • Signed and dated informed consent from the nephrologist.
  • Nephrologist willing to comply with all study procedures and available for the duration of the study.
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia or inability to understand the study and provide informed consent.
  • Active malignancy, except for local non-melanoma skin cancer, renal cell carcinoma less than 5 cm, early thyroid cancer, or prostate cancer with Gleason score 6 or less.
  • Pregnancy (may be re-evaluated after delivery).
  • Active infection, including positive cultures, infected intravascular devices, or specific infections such as histoplasmosis, cryptococcosis, tuberculosis, or nontuberculous mycobacteria.
  • Previously evaluated for kidney transplant and not listed for specific medical reasons.
  • Already listed for kidney transplant.
  • Receiving types of dialysis other than in-center hemodialysis.
  • Currently working with a community health worker at participating sites to address social needs.
  • Planning to move out of the greater New York area within the next year.
  • Providers planning to leave their institutions within the next year.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

NYU Langone Health

New York, New York, United States, 10016

Not Yet Recruiting

2

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

3

Montefiore Einstein

The Bronx, New York, United States, 10467

Not Yet Recruiting

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Research Team

L

Lili Chan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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