NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
Recruiting · NCT06810622 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
Community health worker interventionStandard Care (in control arm)
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- Denver Health and Hospital Authority - Denver, Colorado, United States
- University of New Mexico Health Science Center - Albuquerque, New Mexico, United States