Culturally Informed Care Coordination for Kidney Disease

Overseen By Merle R. Kataoka-Yahiro, DrPH, MPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to coordinate care for Native Hawaiians with early-stage chronic kidney disease (CKD). The goal is to determine if a culturally informed approach improves follow-up care and addresses health disparities. Participants will either receive this specialized coordination (culturally informed care coordination intervention) or continue with their usual care. Suitable candidates are Native Hawaiians involved in the NKFH KEDS program, with specific kidney function levels indicating early-stage CKD. As an unphased trial, this study allows participants to contribute to innovative care strategies that could significantly enhance health outcomes for their community.

Will I have to stop taking my current medications?

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

What prior data suggests that this culturally informed care coordination intervention is safe?

Research has shown that specific safety information for this new approach to assisting individuals with kidney disease is not yet available. This method aims to enhance follow-up care for Native Hawaiians at high risk of kidney disease by respecting their cultural needs. As it does not involve drugs or medical procedures, it is less likely to cause physical side effects compared to traditional treatments. However, due to its novelty, limited data exists to confirm any potential issues. Participants are encouraged to ask questions to fully understand how this method works and what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about culturally informed care coordination for kidney disease because it focuses on tailoring care to fit the cultural needs and preferences of patients. Unlike standard treatments, which often follow a one-size-fits-all approach, this method ensures that care is more personalized and respectful of cultural differences, potentially leading to better patient engagement and outcomes. By improving care follow-up, this approach aims to address the gaps in communication and understanding that can occur in traditional kidney disease management.

What evidence suggests that this culturally informed care coordination intervention is effective for improving kidney disease follow-up among Native Hawaiians?

Research has shown that care tailored to cultural needs can greatly improve health outcomes. In this trial, participants in the Culturally Informed Care Coordination arm will receive a personalized approach designed to enhance follow-up care for Native Hawaiians with kidney disease. Studies have found that culturally appropriate care increases appointment attendance and improves health management. In similar programs, community health workers and patient guides have connected ethnic groups to necessary care. This ensures people receive the right care at the right time, leading to better health results. Overall, this approach could be crucial in addressing kidney disease among Native Hawaiians. ^{1 2 3 6 7}

Who Is on the Research Team?

Merle R Kataoka-Yahiro, DrPH., MPH., MS.

Principal Investigator

University of Hawaii at Manoa

Are You a Good Fit for This Trial?

This trial is for Native Hawaiians who are at high risk of kidney disease, particularly those in the early stages. It aims to improve follow-up care by using a culturally appropriate care coordination model.

Inclusion Criteria

Native Hawaiian (NH) participants from the NKFH KEDS program self-report as Native Hawaiian

Native Hawaiian (NH) participants from the NKFH KEDS program have participated in the NKFH KEDS Program within 3 months

I am Native Hawaiian with kidney function below normal or have high protein in my urine.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Evaluation

Conduct a formative evaluation on the barriers and facilitators of care coordination and follow-up for eGFR and UACR among participants and staff.

12 months

Intervention Evaluation

Evaluate the acceptability and feasibility of a culturally-informed care coordination intervention at selected PCP sites.

6 months

Follow-up

Participants are monitored for the effectiveness of the intervention and re-screening rates.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Culturally informed care coordination intervention

Trial Overview The study is testing a culturally informed care coordination intervention against usual care practices to see if it can better manage kidney disease among Native Hawaiians.

How Is the Trial Designed?

Group I: Culturally Informed Care Coordination Experimental Treatment 2 Interventions

In this ARM, we will trial the culturally informed care coordination intervention to see if improves patient care follow-up

Group II: Usual Care Group Active Control 1 Intervention

In this Arm the Usual Care Group does not have an intervention.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

National Kidney Foundation

Collaborator

Trials

33

Recruited

85,800+

National Kidney Foundation, United States

Collaborator

National Kidney Foundation

Collaborator

Published Research Related to This Trial

Latinx populations experience higher rates of kidney failure compared to non-Latinx Whites, despite similar rates of chronic kidney disease (CKD), highlighting the need for targeted interventions.

Community health worker (CHW) programs can improve outcomes for Latinx individuals with kidney disease by building trust, allowing participant input, and using trauma-informed approaches, but face challenges like systemic barriers and low recruitment, necessitating further research on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. Novick, TK., Cervantes, L., Golestaneh, L., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-kidney-diseases-8-2025-7ab9e

Culturally Informed Care Coordination for Kidney Disease Research shows that culturally tailored interventions, like using community health workers and patient navigators, can improve health outcomes for ethnic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06843603?term=native%20AND%20apex&viewType=Table&checkSpell=&rank=4

Barriers/Facilitators and Care Coordination of Native ... This project's outcome is to improve kidney disease follow-up among early stage NHs at high risk by aligning health equity with a culturally appropriate care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8664704/

Furthering Cultural Safety in Kidney Care Within Indigenous ... In this article, we explored the breadth of the literature regarding Cultural Safety within the context of indigenous kidney health care.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125006214

Cultural model change in kidney disease therapy This research investigates how patient education affects treatment choices of Veterans with kidney disease.

5. kidney.org kidney.org/sites/default/files/v43a_a3.pdf

Measuring Health-Related Outcomes After a Peer-Led ... In fact, peer-led support has been effective in patients with cancer, diabetes, heart disease, depression, HIV/AIDS, multiple sclerosis, brain injury, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4291538/

Reducing CKD risks among vulnerable populations in ... Ethnic/racial and socioeconomic status disparities in the health care and clinical outcomes of patients with chronic kidney disease are pervasive.

7. academic.oup.com academic.oup.com/ckj/article/16/6/914/7075897

Interventions to support decision-making, health literacy and ... Few interventions exist that have been developed or adapted to support ethnic-minority patients living with CKD to improve their health literacy ...