Barriers/Facilitators and Care Coordination of Native Hawaiians & Kidney Disease

NCT06843603 | Not Yet Recruiting

• 1 other identifier: 40709
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant compared to Whites. They have the highest end-stage kidney disease (ESKD) incidence rates in the nation, begin dialysis at younger ages (30-50 years), and one of the most under-studied racial/ethnic groups in chronic kidney disease (CKD) research. 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 coordination systems model.

Conditions

Kidney Disease, Chronic

Keywords

kidney disease, chronic

Outcome Measures

Primary Outcomes (3)

• Acceptability to Intervention

  Acceptability (the degree to which an intervention is perceived a good fit) Acceptability will be measured by a survey likert scale of 1 (not acceptable) - 10 (most acceptable) Name of measurement tool is reference in Procter et al (p. 69): Procter E, Silmere H, Raghavan R, et al. Outcomes for implementation research, conceptual distinctions, measurement challenges, and research agenda. Adm Policy Mental Health. 2022: 38 (2): 65-76.

  9 months

• Adoption of the Intervention

  Adoption (intent to implement) Adoption will be scored as 0 (not at all implemented), 5 (somewhat implemented), and 10 (fully implemented). Name of measurement tool is reference in Procter et al (p. 69): Procter E, Silmere H, Raghavan R, et al. Outcomes for implementation research, conceptual distinctions, measurement challenges, and research agenda. Adm Policy Mental Health. 2022: 38 (2): 65-76.

  9 months

• Feasibility of the Intervention

  Feasibility (possibility of successful implementation), Feasibility will be measured by a survey likert scale of 1 (not feasible) - 10 (most feasible). Name of measurement tool is reference in Procter et al (p. 69): Procter E, Silmere H, Raghavan R, et al. Outcomes for implementation research, conceptual distinctions, measurement challenges, and research agenda. Adm Policy Mental Health. 2022: 38 (2): 65-76.

  9 months

Secondary Outcomes (1)

• Beliefs to Change of the Intervention

  9 months

Study Arms (2)

Culturally Informed Care Coordination

EXPERIMENTAL

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

Behavioral: culturally informed care coordination intervention; Other: No Intervention - Usual Care Group

Usual Care Group

NO INTERVENTION

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

Interventions

culturally informed care coordination intervention BEHAVIORAL

Culturally Informed Care Coordination Strategies

Culturally Informed Care Coordination

No Intervention - Usual Care Group OTHER

No Intervention - Usual Care Group

Culturally Informed Care Coordination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater or equal to 18 years
• self-reported as Native Hawaiian
• eGFR less than 60 ml/min/1.73m2 (Stage 3a-3b CKD) and/or greater or equal to 30 mg/g UACR
• have participated in the NKFH KEDS Program within 3 months
• able to read, write, and speak English.
• able to read, write, and speak English,
• greater or equal to 18 years.

Sponsors & Collaborators

• University of Hawaii: lead
• National Kidney Foundation, United States: collaborator

Study Sites (1)

National Kidney Foundation of Hawaii

Honolulu, Hawaii, 96822-2214, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  University of Hawaii at Manoa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

808-349-8309; merle@hawaii.edu

Kamomilani A. Wong, PhD, MS

CONTACT

808-772-6825; kwong@kidneyhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We propose a mixed method design study with the goal to improve CKD rescreening among early stage high-risk NHs by aligning health equity with a culturally informed care coordination systems model. Guided by the CFIR 2.017, in Aim 1/Year 1 we will conduct a formative evaluation on the barriers and facilitators associated with increasing individual patient follow-up with their PCP after the initial NKFH KEDS screening and develop implementation strategies. Then in Aim 2/Year 2 we will examine the acceptability and feasibility of a selected culturally-informed care coordination intervention.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: New data from AIM 1 and 2 will be to NIH no later than 12 months after the award begins or at the time of publication of the first manuscript from this study. Scientific data included in published manuscripts will be make available at the time of publication, all other data will be made available no later than the end of the award. Data will be preserved and available for as long as the journal or repository allows.
• Access Criteria: Access request will include a description of the research that justifies the use of resources, a research objective and design that described the hypothesis and approach, an analysis plan that includes security safeguards to the data, and a research use statement to be made publicly available. Requesting investigators must sign a Data use Agreement for research data and requestors must have IRB clearance or exemption from their institution. University of Hawaii at Manoa (UHM) Single Entity IRB approval will provide a clear statement identifying all restrictions or limitations on the use of distribution of research materials. The research data submitted to NIH will have proper documentation to ensure meaningful use of data. The study documentation will be in electronic format, comprehensive, and clear to enable investigators to understand the study and data.

Locations

US (1)