RECRUITING

Interventions for Promoting Kidney Transplant Empowerment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Interventions for Promoting Kidney Transplant Empowerment

Quick Facts

Study Start:2025-08-05
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06655857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient inclusion:
  2. * Provision of signed and dated informed consent from the patient.
  3. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  4. * Age 18 - 75 years
  5. * eGFR≤20 mL/min/1.73m2 or on maintenance in-center HD.
  6. * Receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center.
  7. * Community dwelling (i.e., not in a nursing home, currently incarcerated).
  8. * Speak English and/or Spanish.
  9. * Provider Inclusion:
  10. * Provision of signed and dated informed consent from the nephrologist.
  11. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  1. * Patient Exclusion:
  2. * Absolute contraindications to KTx:
  3. * Self-reported or documented diagnosis of dementia, or inability to understand the study and complete informed consent. When the participant's understanding is unclear, the CRC will use a modified MOCA screener to determine eligibility.
  4. * Active malignancy (excluding local non-melanoma skin cancer, renal cell carcinoma \<5 cm, early thyroid cancer, and prostate cancer GS≤6).
  5. * Pregnancy (can be re-evaluated post-delivery).
  6. * Active infection. Patients excluded due to active infection will be evaluated at 30 days or after completing full treatment (whichever is later) to determine eligibility. Examples of active infection include:
  7. * Positive cultures or radiographic evidence of infection
  8. * Infected intravascular devices, such as tunneled catheters and pacemakers
  9. * Active histoplasmosis, cryptococcosis, tuberculosis (TB), and nontuberculous mycobacteria
  10. * Previously evaluated by KTx and not listed for specific medical reasons.
  11. * Patients previously evaluated and not listed will be carefully reviewed by site PI for eligibility
  12. * Already listed for KTx.
  13. * Patients on other types of dialysis other than in-center hemodialysis.
  14. * Self-identify as already engaged with a CHW at participating sites to address unmet social needs.
  15. * Planning to move out of the greater NY area in the next 1 year.
  16. * Provider Exclusion:
  17. * Planning to leave their respective institutions in the next 1 year

Contacts and Locations

Study Contact

Lili Chan
CONTACT
929-618-0350
lili.chan@mountsinai.org

Principal Investigator

Lili Chan
PRINCIPAL_INVESTIGATOR
Ichan School of Medicine at Mount Sinai Hospital

Study Locations (Sites)

Montefiore Einstein
Bronx, New York, 10467
United States
NYU Langone Health
New York City, New York, 10016
United States
Mount Sinai Hospital
New York City, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Lili Chan, PRINCIPAL_INVESTIGATOR, Ichan School of Medicine at Mount Sinai Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Transplant Waitlisting