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

NCT06810622 | Recruiting Phase 2

• 1 other identifier: 23-2014
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals 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 individuals with advanced CKD. The project will have four (4) aims.

Conditions

Kidney Diseases; Chronic Kidney Diseases

Keywords

Kidney; Chronic; Dialysis; Transplant

Outcome Measures

Primary Outcomes (1)

• Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death

  Composite outcome of time until participants in each arm either 1) begin dialysis (either as first KRT method or as a subsequent preparatory step for transplant) with a central venous catheter (CVC)), or 2) die from all-cause mortality, whichever occurs first.

  From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

Secondary Outcomes (10)

• Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death

  From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

• Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start

  From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

• Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone

  From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

• Change in Estimated Glomerular Filtration Rate eGFR

  Screening until End of Study or Death, whichever occurs first (up to 5 years)

• Change in Decisional Conflict Scale (DCS) scores

  Baseline, Month 6, Month 12, Month 24

Other Outcomes (2)

• Dissemination and implementation RE-AIM outcomes for Navigate-Kidney

  Baseline up to End of Study (up to 5 Years)

• Economic Evaluation Outcomes

  Baseline up to End of Study (up to 5 Years)

Study Arms (2)

Navigate-Kidney CHW Arm

EXPERIMENTAL

Arm Description: 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 1 year of study participation and then quarterly visits until 2 years of study participation. The CHW Navigate-Kidney intervention includes 4 functions: (1) Build trust through understanding of health experience; (2) Address multilevel social and challenges to facilitate health system navigation; (3) Provide patient-centered education; and (4) Enhance self-management. To provide patient-centered education, the CHW will use a Decision Aid created for this intervention.

Behavioral: Community health worker intervention

Standard Care

ACTIVE COMPARATOR

Arm Description: Arm Description: 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

Behavioral: Standard Care (in control arm)

Interventions

Community health worker intervention BEHAVIORAL

Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.

Navigate-Kidney CHW Arm

Standard Care (in control arm) BEHAVIORAL

Participants receive standard care

Standard Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of New Mexico: collaborator
• Denver Health and Hospital Authority: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Bronchiolitis Obliterans Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lilia Cervantes, MD

  University of Colorado-Anschutz SOM-Hospital Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilia Cervantes, MD

CONTACT

3036418009; lilia.cervantes@cuanschutz.edu

Sandra Hernandez, MPH

CONTACT

SANDRA.GARCIA-HERNANDEZ@CUANSCHUTZ.EDU

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: February 5, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): May 15, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 12 months of Primary Completion Date, ongoing.

Locations

US (2)