BridgeMD
New treatment option for Kidney Transplant Waitlisting
Official title Interventions for Promoting Kidney Transplant Empowerment
ClinicalTrials.gov ID: NCT06655857
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.