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Community Health Interventions for Renal Disease (INSPIRE Trial)

N/A

Waitlist Available

Led By Lili Chan

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must speak English and/or Spanish

Patient must be aged between 18 and 75 years

Must not have

Patient must have absolute contraindications to KTx such as self-reported or documented diagnosis of dementia, inability to understand the study and complete informed consent, active malignancy (excluding specific cases), pregnancy, or active infection

Patient must be on other types of dialysis besides in-center hemodialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and then every 6 months up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using community health workers and providing education to healthcare providers can help more people with kidney disease get on the transplant waiting list. The trial will compare this approach to the standard care.

Who is the study for?

This trial is for patients with renal disease who are under the care of CKD/HD providers. Participants will be grouped based on their provider's random assignment to either the intervention or control group. The study aims to help those facing social challenges that affect their health.

What is being tested?

The trial is testing if support from community health workers and additional education for kidney transplant providers can increase the number of patients getting on a transplant waitlist, compared to usual care without this extra support.

What are the potential side effects?

Since this trial involves non-medical interventions like education and community assistance rather than drugs, typical medication side effects are not expected. However, there may be indirect effects related to changes in healthcare management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English or Spanish.

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I am between 18 and 75 years old.

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My kidney function is very low or I am on regular dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have a kidney transplant due to conditions like dementia, active cancer, pregnancy, or an ongoing infection.

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I am on a form of dialysis that is not in-center hemodialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and then every 6 months up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and then every 6 months up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and then every 6 months up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to completion of kidney transplant waitlisting evaluation

Secondary study objectives

Accountable Health Communities Health-Related Social Needs Screening Tool (AHC-HRSN)

Binary outcome of patient being KTx waitlisted or not by year 1 post enrollment

Binary outcome of patient being KTx waitlisted or not by year 2 post enrollment

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment3 Interventions

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.

Group II: Community Health Worker and Intervention Providers-Assisted Kidney Transplant SupportExperimental Treatment2 Interventions

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.

0 / 5Eligibility criteria met