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NCT06810622 | NOT YET RECRUITING | Kidney Diseases

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

University of Colorado, Denver

Brief 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.

Condition or disease

Kidney Diseases

Chronic Kidney Diseases

Intervention/treatment

Navigate-Kidney CHW

Standard Care

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 450 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : NAVIGATE CKD: A Community-engaged Multi-level Intervention to Reduce Kidney Disparities Among Latinos With Kidney Disease
Actual Study Start Date : 2025-05-30
Estimated Primary Completion Date : 2027-09-30
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adults ≥ 18 years of age,
  • * Adults who self-identify as Latino/e/a/x and/or Hispanic,
  • * Adults who are not pregnant,
  • * Adults who are not incarcerated,
  • * Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.
Exclusion Criteria
  • * Anyone who does not meet the criteria outlined above.
NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

Location Details

NCT06810622

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Colorado

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Not yet recruiting

United States, New Mexico

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States, 87131