450 Participants Needed

NAVIGATE-Kidney Program for Kidney Disease

(NAV-Kidney Trial)

Recruiting at 1 trial location
SH
LC
Overseen ByLilia Cervantes, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Navigate-Kidney CHW for kidney disease?

Research shows that patient navigator programs and enhanced personal health records can improve healthcare quality for chronic kidney disease (CKD) patients. Additionally, adherence to a multidisciplinary renal health program has been effective in reducing the need for dialysis and lowering mortality rates in CKD patients.12345

What safety data exists for the NAVIGATE-Kidney Program for Kidney Disease?

The available research highlights that chronic kidney disease (CKD) patients are at high risk for safety issues, such as medication errors and adverse events, due to impaired kidney function and frequent healthcare interactions. While specific safety data for the NAVIGATE-Kidney Program is not provided, the general safety concerns for CKD patients are well-documented, emphasizing the need for careful monitoring and management to prevent harm.16789

How is the NAVIGATE-Kidney CHW treatment different from other kidney disease treatments?

The NAVIGATE-Kidney CHW treatment is unique because it involves patient navigators who help coordinate care, address system barriers, and educate patients, which is not a standard approach in kidney disease management. This program aims to improve outcomes by providing personalized support and education, similar to successful strategies used in cancer care.12101112

What is the purpose of this trial?

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for Latinx 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 Latinx with advanced CKD. The project will have four (4) aims.

Research Team

LC

Lilia Cervantes, MD

Principal Investigator

University of Colorado-Anschutz SOM-Hospital Medicine

Eligibility Criteria

The NAVIGATE Kidney trial is for Latinx individuals with advanced Chronic Kidney Disease (CKD). It aims to improve kidney health outcomes by testing a program called NAVIGATE-Kidney. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions related to CKD.

Inclusion Criteria

Adults who self-identify as Latino/e/a/x and/or Hispanic
I am not pregnant.
I am not currently in prison or jail.
See 1 more

Exclusion Criteria

Anyone who does not meet the criteria outlined above.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the NAVIGATE-Kidney intervention with support from a community health worker every 2 weeks for 3 months, followed by monthly visits

3 months
6 visits (in-person) during first 3 months, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of patient-centered outcomes and implementation outcomes

Up to 5 years

Economic Evaluation

Economic evaluation to determine the cost-effectiveness of the NAVIGATE-Kidney intervention

Up to 5 years

Treatment Details

Interventions

  • Navigate-Kidney CHW
Trial Overview This study tests the effectiveness of the NAVIGATE-Kidney program compared to standard care in reducing central venous catheter use at kidney replacement therapy start and improving other patient-centered outcomes like activation and decision-making.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: NAVIGATE-Kidney ControlExperimental Treatment1 Intervention
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.
Group II: NAVIGATE-Kidney CHWExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

University of New Mexico

Collaborator

Trials
393
Recruited
3,526,000+

Denver Health and Hospital Authority

Collaborator

Trials
106
Recruited
403,000+

Findings from Research

Patient navigators can improve certain health outcomes for patients with chronic kidney disease (CKD) and kidney failure, such as enhancing transplant workup and listing, increasing peritoneal dialysis utilization, and boosting patient knowledge, based on a review of 17 studies.
However, many studies had a high risk of bias and did not demonstrate benefits across all outcomes, highlighting the need for more rigorous randomized controlled trials to assess the overall efficacy and cost-effectiveness of navigator programs.
Patient Navigators for CKD and Kidney Failure: A Systematic Review.Taha, A., Iman, Y., Hingwala, J., et al.[2022]
A study involving 1486 patients with chronic kidney disease (CKD) showed that participation in CKD care programs led to a slight increase in the overall goal attainment rate from 59.4% to 60.5% over three years, particularly improving management of low-density lipoprotein and glycated hemoglobin levels.
Patients who achieved their treatment goals experienced better preservation of kidney function, as their estimated glomerular filtration rate (eGFR) did not decline, while those with poor goal achievement saw a significant decrease in eGFR.
Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study.Wang, Y., Lee, YT., Lee, WC., et al.[2022]
Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.
Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.
Finding a common language for patient safety in CKD.Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

References

Patient Navigators for CKD and Kidney Failure: A Systematic Review. [2022]
Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD. [2023]
Effectiveness of adherence to a renal health program in a health network in Peru. [2020]
A crucial lifeline: reducing mortality in the first 120 days. [2019]
Goal attainment and renal outcomes in patients enrolled in the chronic kidney disease care program in Taiwan: a 3-year observational study. [2022]
Finding a common language for patient safety in CKD. [2019]
Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]
CKD as an underrecognized threat to patient safety. [2023]
NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol. [2022]
Development of a chronic kidney disease patient navigator program. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Screening populations at increased risk of CKD: the Kidney Early Evaluation Program (KEEP) and the public health problem. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Pharmacy program with DM component targets CKD. [2008]
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