Clinical trial NCT06810622: NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
Official title: NAVIGATE CKD: A Community-engaged Multi-level Intervention to Reduce Kidney Disparities Among Latinos With Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Chronic Kidney Diseases
Keywords: Kidney
Chronic
Dialysis
Transplant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Denver Health and Hospital Authority
name: Weill Medical College of Cornell University
First posted: 2025-02-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our clinical trial is a multi-site, unblinded, patient-level randomized controlled trial that will randomize 450 adult Latinx individuals with CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The two arms include: (1) NAVIGATE-Kidney, a CHW Arm, in which 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 or (2) a Control (standard care) Arm.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death
timeFrame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Secondary outcomes:
measure: Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death
timeFrame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
measure: Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start
timeFrame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
measure: Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone
timeFrame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
measure: Change in Estimated Glomerular Filtration Rate eGFR
timeFrame: Screening until End of Study or Death, whichever occurs first (up to 5 years)
measure: Change in Decisional Conflict Scale (DCS) scores
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Change in Patient Activation (PAM-13) scores
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Change in Social Determinants of Health, as measured by AHC-HRSN Responses
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items)
timeFrame: Baseline, Month 6, Month 12, Month 24
measure: Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI)
timeFrame: Baseline, Month 6, Month 12, Month 24
Other outcomes:
measure: Dissemination and implementation RE-AIM outcomes for Navigate-Kidney
timeFrame: Baseline up to End of Study (up to 5 Years)
measure: Economic Evaluation Outcomes
timeFrame: Baseline up to End of Study (up to 5 Years)
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
Study officials:
affiliation: University of Colorado-Anschutz SOM-Hospital Medicine
name: Lilia Cervantes, MD
role: PRINCIPAL_INVESTIGATOR
References: