Kidney DiseasesNAV-KidneyNCT06810622
NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
A study testing Community health worker intervention in people with Kidney Diseases and Chronic Kidney Diseases, run by University of Colorado, Denver at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Diseases, Chronic Kidney Diseases
- What is being tested?
- Community health worker intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2026to 15 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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*
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sandra Hernandez, MPH contact
United States2 sites, 2 recruiting
- Not yet recruiting
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131
Larissa Myaskovsky, PhD, 505-272-0070, lmaskovsky@salud.unm.edu
Mark Unruh, MD, 5052720407, mlunruh@salud.unm.edu
- Recruiting
Denver Health and Hospital Authority
Denver, Colorado, 80204
Seth Furgeson, MD, 303-724-5063, seth.furgeson@dhha.org
Rocio Pereira, MD, 3034366000, rocio.perieira@dhha.org
About this study
Official title: Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
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.
Read the 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.
- Conditions
- Kidney Diseases, Chronic Kidney Diseases
- Being tested
- Community health worker intervention, Standard Care (in control arm)
- Keywords
- Kidney, Chronic, Dialysis, Transplant
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker interventionBehavioural
Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.
Standard Care (in control arm)Behavioural
Participants receive standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Rate of participants in each arm that either 1) "crash start" Kidney Replacement Therapy (KRT) via first starting dialysis with a Central Venous Catheter (CVC), or 2) die from all-cause mortality prior to starting any method of KRT, whichever occurs first.
Measured: 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
Rate of patients with condition: "Optimal KRT start", a composite measure (defined by the CMS Kidney Care Choices (KCC) value-based payment model) that includes patients with any of the following: 1. Pre-emptive kidney transplant; 2. Home dialysis; and/or 3. In-center dialysis start with a functional arteriovenous fistula or graft.
Measured: 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
Optimal Kidney Replacement Therapy (KRT) start process measure milestones are defined as the following: (1) Endpoints for permanent vascular access: vascular mapping and surgical visit or referral; (2) Endpoints for kidney transplant: Initial transplant visit, undergoing work-up for waitlisting, and waitlisting; (3) Endpoints for home dialysis: Initial evaluation visit for home dialysis.
Measured: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)
Change in Estimated Glomerular Filtration Rate eGFR
Measure of kidney function, reported in mg/dL. Scores of less than 15 may indicate kidney failure, while scores of 90 or higher indicate normal kidney function.
Measured: Screening until End of Study or Death, whichever occurs first (up to 5 years)
Change in Decisional Conflict Scale (DCS) scores
Decisional Conflict Scale (DCS) is a 16-item tool that evaluates patient decisional conflict in 4 domains: informed, clarity, uncertainty, and support. Possible total scores range from 0 to 100, with higher scores indicating higher decisional conflict and worse outcomes.
Measured: Baseline, Month 6, Month 12, Month 24
Change in Patient Activation (PAM-13) scores
Patient activation is measured with the Patient Activation Measure 13 (PAM-13), ranging in scores from 0 to 100. Higher scores are associated with improved behaviors related to the patient's self-management of their health and disease, and a better outcome.
Measured: 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
The PROMIS Global Health Scale Version 1.2. is a 10-item tool that evaluates self-reported measures of patients' physical health and function. Possible scores range from 1-10, with higher scores indicating better health and function, and better outcomes.
Measured: Baseline, Month 6, Month 12, Month 24
Change in Social Determinants of Health, as measured by AHC-HRSN Responses
The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool is a 10-item, tool that identifies health-related social needs (HRSNs) in patients in 5 domains: Housing Instability, Food Insecurity, Transportation Problems, Interpersonal Safety, and Utility Help needs. Each item is scored using a Yes/No response format. Yes answers indicate a positive screening for a patient need.
Measured: Baseline, Month 6, Month 12, Month 24
Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items)
The Rotterdam Renal Replacement Knowledge test (R3K-T) is a 30-item tool that assesses participant knowledge of renal replacement therapy. Possible scores range from 0 to 30, with higher scores indicating more correct answers and higher participant knowledge about therapy.
Measured: Baseline, Month 6, Month 12, Month 24
Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI)
The Medical Mistrust Index (MMI) is an 11-item measure that evaluates participants' mistrust of health care organizations. The MMI items are scored on a 4-response Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating more mistrust of healthcare organizations
Measured: Baseline, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Mar 2026
- Primary completion15 May 2029 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Denver Health and Hospital Authority, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Lilia Cervantes, MD, Principal investigator, University of Colorado-Anschutz SOM-Hospital Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810622
- Sponsor's protocol ID
- 23-2014
- Acronym
- NAV-Kidney
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited data sets will be shared at end of study via an NIDDK registry: NIDDK-CR, in accordance with NIDDK data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
- ClinicalTrials.gov ID
- NCT06810622
- Acronym / sponsor ID
- NAV-Kidney / 23-2014
- Conditions
- Kidney Diseases, Chronic Kidney Diseases
- Keywords
- Kidney, Chronic, Dialysis, Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of New Mexico, Denver Health and Hospital Authority, Weill Medical College of Cornell University
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 15 May 2029 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Navigate-Kidney CHW Arm | Experimental | Behavioral: Community health worker interventionArm 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. |
| Standard Care | Active comparator | Behavioral: Standard Care (in control arm)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community health worker interventionCommunity health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management. | Behavioural | Navigate-Kidney CHW Arm |
| Standard Care (in control arm)Participants receive standard care | Behavioural | Standard Care |
Primary outcome
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)
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. Limited data sets will be shared at end of study via an NIDDK registry: NIDDK-CR, in accordance with NIDDK data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Hernandez, MPH contact
Lilia Cervantes, MD principal investigator
University of Colorado-Anschutz SOM-Hospital Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker intervention in people with Kidney Diseases and Chronic Kidney Diseases, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilia Cervantes, MD (3036418009, lilia.cervantes@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.