NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community health worker intervention, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Kidney Diseases, Chronic Kidney Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
Overview
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.
Detailed description
The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. 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 individuals 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.
Interventions
- Behavioral Community health worker intervention
Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management. - Behavioral Standard Care (in control arm)
Participants receive standard care
Primary outcome measures
- 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)]
Secondary outcome measures (10)
- Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death [Time frame: 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 [Time frame: 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 [Time frame: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)]
- Change in Estimated Glomerular Filtration Rate eGFR [Time frame: Screening until End of Study or Death, whichever occurs first (up to 5 years)]
- Change in Decisional Conflict Scale (DCS) scores [Time frame: Baseline, Month 6, Month 12, Month 24]
- Change in Patient Activation (PAM-13) scores [Time frame: Baseline, Month 6, Month 12, Month 24]
- Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores [Time frame: Baseline, Month 6, Month 12, Month 24]
- Change in Social Determinants of Health, as measured by AHC-HRSN Responses [Time frame: Baseline, Month 6, Month 12, Month 24]
- Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items) [Time frame: Baseline, Month 6, Month 12, Month 24]
- Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI) [Time frame: Baseline, Month 6, Month 12, Month 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Denver Health and Hospital Authority — Denver
- University of New Mexico Health Science Center — Albuquerque
Identifiers
NCT: NCT06810622 · 23-2014