Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD

NCT ID: NCT05734989

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-18

Study Completion Date

2025-04-04

Brief Summary

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In this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP. Additionally, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating patients with diabetes.

Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.

Detailed Description

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The goals of this study are to (1) Increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events and (2) Pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipate the study will identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx.

Conditions

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Type 2 Diabetes Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hispanic/Latinx patients at risk for CKD

Adult patients in the Hispanic/Latinx Durham community screened for CKD

BP

Intervention Type DIAGNOSTIC_TEST

Blood pressure measurements and HbA1c tests will be conducted to identify participants with or at risk for high blood pressure and/or Type 2 Diabetes. Those identified will be referred to PCP for follow up/treatment.

HbA1c

Intervention Type DIAGNOSTIC_TEST

HbA1c will screen to identify patients with Type 2 diabetes

PCPs caring for Hispanic Latinx patients screened for CKD in the Durham Community

Primary Care Providers (PCPs) caring for Hispanic Latinx patients who agree to use the study guidelines and interventions for screening and monitoring their patients for CKD.

PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD

Intervention Type BEHAVIORAL

Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD.

Interventions

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BP

Blood pressure measurements and HbA1c tests will be conducted to identify participants with or at risk for high blood pressure and/or Type 2 Diabetes. Those identified will be referred to PCP for follow up/treatment.

Intervention Type DIAGNOSTIC_TEST

HbA1c

HbA1c will screen to identify patients with Type 2 diabetes

Intervention Type DIAGNOSTIC_TEST

PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD

Guidelines will be developed and provided to PCPs to use with their Hispanic/Latinx patients with or at risk for CKD.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older at time of screening
* Self-identifying as Hispanic/Latinx ethnicity.

Exclusion Criteria

* Unable to be reached by telephone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Sinclair, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00112455

Identifier Type: -

Identifier Source: org_study_id

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