RecruitingRecruiting
NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
NCT06810622 · University of Colorado, Denver
In plain English
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Official title
Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
About this study
The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. 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 individuals 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.
Eligibility criteria
Inclusion Criteria:
* Adults ≥ 18 years of age,
* 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:
* Previous kidney transplant
* Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
* On chronic dialysis
* Conservative management or primary goal is palliation
* Incarcerated
* Pregnant\*
* Under 18 years of age
* Moderate to severe dementia
* Deaf persons
* Lacking health insurance\*\*
* Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.
Study design
Enrollment target: 448 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-18
Estimated completion: 2029-05-15
Last updated: 2026-05-01
Interventions
Behavioral: Community health worker interventionBehavioral: Standard Care (in control arm)
Primary outcomes
- • Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death (From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years))
Sponsor
University of Colorado, Denver · other
With: University of New Mexico, Denver Health and Hospital Authority, Weill Medical College of Cornell University
Contacts & investigators
ContactLilia Cervantes, MD · contact · lilia.cervantes@cuanschutz.edu · 3036418009
ContactSandra Hernandez, MPH · contact · SANDRA.GARCIA-HERNANDEZ@CUANSCHUTZ.EDU
InvestigatorLilia Cervantes, MD · principal_investigator, University of Colorado-Anschutz SOM-Hospital Medicine
All locations (2)
Denver Health and Hospital AuthorityRecruiting
Denver, Colorado, United States
University of New Mexico Health Science CenterNot Yet Recruiting
Albuquerque, New Mexico, United States