NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Community health worker intervention
- Standard Care (in control arm)
Treatment groups
448 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
University of New Mexico
Collaborator
Denver Health and Hospital Authority
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov