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

Type 2 Diabetes Clinical Trial

Official title:

Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05734989
• Other study ID #: Pro00112455
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: Matthew Sinclair, MD
• Phone: 1 919 668 0113
• Email: matthew.sinclair[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 31, 2025
• Est. primary completion date: April 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Aim 1:

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to be reached by telephone

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Diagnostic Test:
• 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.
• HbA1c
HbA1c will screen to identify patients with Type 2 diabetes

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients referred to PCPs (Primary Care Providers) for CKD screening	Increase rates of screening and monitoring of Chronic Kidney Disease (CKD) and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events	3 months from referral