NAVIGATE-Kidney Program for Kidney Disease

(NAV-Kidney Trial)

Not yet recruiting at 1 trial location

Overseen By Lilia Cervantes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latinx individuals with advanced kidney disease improve their treatment outcomes. It will test a program called NAVIGATE-Kidney, in which a community health worker supports participants through regular visits. The goal is to reduce the need for certain dialysis methods and empower patients in their treatment decisions. Individuals who self-identify as Latino/e/a/x or Hispanic and have advanced kidney disease might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment options for the Latinx community.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the NAVIGATE-Kidney program is safe for Latinx with CKD?

Research has shown that the NAVIGATE-Kidney program employs a community health worker (CHW) to assist individuals with kidney disease in managing their health. This program involves no drugs or surgeries, eliminating typical medication side effects. Instead, it focuses on providing guidance and support.

Studies have found that participants respond well to the CHW approach, reporting positive experiences and finding the support beneficial in managing their condition. No evidence indicates harm or negative effects from the CHW visits.

With an emphasis on education and support, the program presents low risks. Participants primarily receive assistance in understanding their condition and making informed health decisions, making it a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NAVIGATE-Kidney Program because it offers a fresh approach to managing kidney disease by integrating community health worker (CHW) support. Unlike standard treatments, which generally focus on medical management and patient education, this program emphasizes personalized support through regular CHW visits every two weeks for the first three months, followed by monthly visits. This hands-on approach aims to improve patient engagement and adherence to treatment plans, potentially slowing disease progression more effectively than conventional methods alone.

What evidence suggests that the NAVIGATE-Kidney CHW program is effective for kidney disease?

Research has shown that the NAVIGATE-Kidney program, which employs community health workers (CHWs), can effectively assist patients with kidney disease. In this trial, participants in the NAVIGATE-Kidney CHW arm will receive support from CHWs during visits every two weeks for three months, followed by monthly visits. Studies have found that CHWs reduce health disparities and promote better self-care among patients. This program specifically aims to improve health outcomes for Latinx individuals with kidney failure by enhancing their medical results and experiences. Participants in past studies reported positive experiences with CHWs, who provided guidance and support. This approach is designed to increase patient involvement in their own care and help them make better treatment decisions. ^{1 2 3 4 6}

Who Is on the Research Team?

Lilia Cervantes, MD

Principal Investigator

University of Colorado-Anschutz SOM-Hospital Medicine

Are You a Good Fit for This Trial?

The NAVIGATE Kidney trial is for Latinx individuals with advanced Chronic Kidney Disease (CKD). It aims to improve kidney health outcomes by testing a program called NAVIGATE-Kidney. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions related to CKD.

Inclusion Criteria

Adults who self-identify as Latino/e/a/x and/or Hispanic

I am not pregnant.

I am not currently in prison or jail.

Exclusion Criteria

Anyone who does not meet the criteria outlined above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NAVIGATE-Kidney intervention with support from a community health worker every 2 weeks for 3 months, followed by monthly visits

3 months

6 visits (in-person) during first 3 months, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of patient-centered outcomes and implementation outcomes

Up to 5 years

Economic Evaluation

Economic evaluation to determine the cost-effectiveness of the NAVIGATE-Kidney intervention

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Navigate-Kidney CHW

Trial Overview This study tests the effectiveness of the NAVIGATE-Kidney program compared to standard care in reducing central venous catheter use at kidney replacement therapy start and improving other patient-centered outcomes like activation and decision-making.

How Is the Trial Designed?

Group I: NAVIGATE-Kidney Control Experimental Treatment 1 Intervention

Participants will receive standard medical care following diagnosis. This care will include educational materials developed that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish.

Group II: NAVIGATE-Kidney CHW Experimental Treatment 1 Intervention

A CHW will provide support during visits every 2 weeks for 3 months (i.e., 6 visits during first 3 months) followed by monthly visits until end of study or until 3 months following KRT start.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Published Research Related to This Trial

A study involving 1486 patients with chronic kidney disease (CKD) showed that participation in CKD care programs led to a slight increase in the overall goal attainment rate from 59.4% to 60.5% over three years, particularly improving management of low-density lipoprotein and glycated hemoglobin levels.

Patients who achieved their treatment goals experienced better preservation of kidney function, as their estimated glomerular filtration rate (eGFR) did not decline, while those with poor goal achievement saw a significant decrease in eGFR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study. Wang, Y., Lee, YT., Lee, WC., et al.[2022]

The National Kidney Foundation's Kidney Early Evaluation Program (KEEP) effectively identifies chronic kidney disease (CKD) in high-risk populations, with 28.7% of the 100,000 participants screened found to have CKD, compared to a lower prevalence of 13.1% reported in the general population.

KEEP's structured screening approach not only detects CKD early but also enhances understanding of kidney disease, supporting public health initiatives aimed at improving outcomes for individuals with diabetes, hypertension, or a family history of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. Vassalotti, JA., Li, S., Chen, SC., et al.[2022]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

Patient navigators can improve certain health outcomes for patients with chronic kidney disease (CKD) and kidney failure, such as enhancing transplant workup and listing, increasing peritoneal dialysis utilization, and boosting patient knowledge, based on a review of 17 studies.

However, many studies had a high risk of bias and did not demonstrate benefits across all outcomes, highlighting the need for more rigorous randomized controlled trials to assess the overall efficacy and cost-effectiveness of navigator programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigators for CKD and Kidney Failure: A Systematic Review. Taha, A., Iman, Y., Hingwala, J., et al.[2022]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595532/

Participant Experiences in a Kidney Failure Care ... In conclusion, this study sheds light on the patient perspective on CHW activities in the Navigate-Kidney intervention. These findings not only ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925006540

Adaptation of Navigate-Kidney: A Community Health ... Community health worker (CHW) interventions have been effective in reducing health disparities and promoting self-management; however, they have ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2841228

Participant Experiences in a Kidney Failure Care Intervention In conclusion, this study sheds light on the patient perspective on CHW activities in the Navigate-Kidney intervention. These findings not only ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06810622

NAVIGATE Kidney: A Multi-level Intervention to Reduce ... The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for Latinx with kidney failure ...

5. reporter.nih.gov reporter.nih.gov/project-details/11126805

A Multi-Level Intervention to Reduce Kidney Health Disparities We will determine the effectiveness of NAVIGATE-Kidney compared to standard ... CKD, that will reduce kidney health disparities, and address structural racism.

6. withpower.com withpower.com/trial/phase-renal-insufficiency-chronic-2025-e149f

NAVIGATE-Kidney Program for Kidney Disease The available research highlights that chronic kidney disease (CKD) patients are at high risk for safety issues, such as medication errors and adverse events, ...