Interventions for Promoting Kidney Transplant Empowerment
NCT ID: NCT06655857
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2025-08-05
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support
Participants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services.
Community Health Worker Assistance
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Intervention Providers
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).
Usual Care
Participants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention.
Usual Care
Participants are provided care as usual. Clinicians (CKD, HD, KTx) will educate participants on the kidney transplant process. Clinician will receive the education intervention to provide participants at study end.
Community Health Worker Assistance
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Intervention Providers
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).
Interventions
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Usual Care
Participants are provided care as usual. Clinicians (CKD, HD, KTx) will educate participants on the kidney transplant process. Clinician will receive the education intervention to provide participants at study end.
Community Health Worker Assistance
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Intervention Providers
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).
Eligibility Criteria
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Inclusion Criteria
* Provision of signed and dated informed consent from the patient.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Age 18 - 75 years
* eGFR≤20 mL/min/1.73m2 or on maintenance in-center HD.
* Receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center.
* Community dwelling (i.e., not in a nursing home, currently incarcerated).
* Speak English and/or Spanish.
* Provider Inclusion:
* Provision of signed and dated informed consent from the nephrologist.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria
* Absolute contraindications to KTx:
* 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.
* Active malignancy (excluding local non-melanoma skin cancer, renal cell carcinoma \<5 cm, early thyroid cancer, and prostate cancer GS≤6).
* Pregnancy (can be re-evaluated post-delivery).
* 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:
* Positive cultures or radiographic evidence of infection
* Infected intravascular devices, such as tunneled catheters and pacemakers
* Active histoplasmosis, cryptococcosis, tuberculosis (TB), and nontuberculous mycobacteria
* Previously evaluated by KTx and not listed for specific medical reasons.
* Patients previously evaluated and not listed will be carefully reviewed by site PI for eligibility
* Already listed for KTx.
* Patients on other types of dialysis other than in-center hemodialysis.
* Self-identify as already engaged with a CHW at participating sites to address unmet social needs.
* Planning to move out of the greater NY area in the next 1 year.
* Provider Exclusion:
* Planning to leave their respective institutions in the next 1 year
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Lili Chan
Associate Professor
Principal Investigators
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Lili Chan
Role: PRINCIPAL_INVESTIGATOR
Ichan School of Medicine at Mount Sinai Hospital
Locations
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NYU Langone Health
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Einstein
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GCO 22-1921
Identifier Type: -
Identifier Source: org_study_id
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