Interventions for Promoting Kidney Transplant Empowerment (INSPIRE)

April 29, 2026 updated by: Lili Chan, Icahn School of Medicine at Mount Sinai
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
      • New York, New York, United States, 10016
      • The Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Einstein
        • Contact:
        • Principal Investigator:
          • Tanya Johns

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient inclusion:

    • 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:

  • Patient Exclusion:

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: Community Health Worker Assistance
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Other: 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).
Other: 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.
Other: Community Health Worker Assistance
Community health worker will address unmet social needs and participant symptoms through evaluations and intake to clinical and community services
Other: 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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to completion of kidney transplant waitlisting evaluation
Time Frame: Baseline, and then every 6 months up to 2 years
Patient medical records will be reviewed, and the patient will be asked directly for the status of their kidney transplant evaluation.
Baseline, and then every 6 months up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)
Time Frame: Baseline, and then every 6 months up to 2 years
The AHC-HRSN is a 10-item screening tool designed to help providers identify patients' needs across five core domains: Housing Instability, Food Insecurity, Transportation Problems, Interpersonal Safety, and Utility Help needs. Each item is scored using a Yes/No response format. If a patient answers "Yes" to any of the items, they are considered to have screened positive for a safety need.
Baseline, and then every 6 months up to 2 years
Discrimination in Medical Settings (DMS)
Time Frame: Baseline, and 12 months after first study visit
The Discrimination in Medical Settings (DMS) Scale is a modified version of the EDS that has been previously used to study perceived discrimination in medical settings, among patients with a range of clinical conditions. Responses to each of the 7 items are assessed with a 5-point Likert scale. Scores range from 7-35. Higher scores indicate higher frequencies of experiences with everyday mistreatment.
Baseline, and 12 months after first study visit
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2
Time Frame: Baseline, and 12 months after first study visit
The Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health is a patient reported measure of physical, mental and social health. Items query general health, quality of life, physical health, mental health, satisfaction with discretionary social activities, carrying out every day physical activities, pain, fatigue, satisfaction with social roles, and emotional problems. For scoring, Item-levels are scored numerically for an individual's response to each question. Responses to each of the items are assessed with a 5-point Likert scale. Raw scores range from 7-35. Higher scores indicate higher presence of symptom.
Baseline, and 12 months after first study visit
Initiation of KTx process
Time Frame: Baseline, and 12 months after first study visit
Will measure whether or not the patient started the kidney transplant process. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly. A response of yes/no will be recorded.
Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment
Time Frame: Baseline, and 12 months after first study visit
Will measure whether or not the patient has been waitlisted for a kidney transplant at 1 year out from being enrolled in the trial. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly for confirmation. A response of yes/no will be recorded.
Baseline, and 12 months after first study visit
Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment
Time Frame: Baseline, and then every 6 months up to 2 years after patients first study visit
Will measure whether or not the patient has been waitlisted for a kidney transplant at 2 years out from being enrolled in the trial. Patient medical records will be reviewed to see if there is a date available and/or ask the patient directly for confirmation. A response of yes/no will be recorded.
Baseline, and then every 6 months up to 2 years after patients first study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lili Chan, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 22-1921
  • U01DK137259 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be deidentified for analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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