NCT06810622

NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

NAVIGATE CKD: A Community-engaged Multi-level Intervention to Reduce Kidney Disparities Among Latinos With Kidney Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for Latinx with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD. The project will have four (4) aims.

Detailed description

The overarching goal of this project is to eliminate structural racism and reduce kidney health disparities faced by Latinx (gender-inclusive term; includes Hispanics, Latino/a/x) individuals. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for Latinx with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4/5. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.

Conditions

• Kidney Diseases
• Chronic Kidney Diseases

Interventions

Type	Name	Description
OTHER	Navigate-Kidney CHW	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. As well as receiving educational materials that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish
OTHER	Standard Care	Participants will receive standard medical care as well as educational materials developed that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish

Timeline

• Start date: 2025-05-30
• Primary completion: 2027-09-30
• Completion: 2028-12-31
• First posted: 2025-02-05
• Last updated: 2025-03-28

Locations

2 sites across 1 country: United States