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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06810622
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Diseases
  • Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • Standard Care (in control arm) — BEHAVIORAL
    Participants receive standard care

Study Details

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.

Key Dates

Start date
Mar 18, 2026
Status verified
Apr 2026
Primary completion
May 15, 2029
Completion
May 15, 2029

Study Design

Enrollment
448 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Navigate-Kidney CHW Arm
    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.
  • Active Comparator: Standard Care
    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

Primary Outcome Measure

Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death [ Time Frame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Denver Health and Hospital AuthorityDenverColorado80204
Seth Furgeson, MD
[email protected]
3037245063
Rocio Pereira, MD
[email protected]
3034366000
Seth Furgeson, MD (PRINCIPAL_INVESTIGATOR)
University of New Mexico Health Science CenterAlbuquerqueNew Mexico87131
Larissa Myaskovsky, PhD
[email protected]
5052720070
Mark Unruh, MD
[email protected]
5052720407

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By research site
Denver Health and Hospital Authority· Denver, COUniversity of New Mexico Health Science Center· Albuquerque, NM

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