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

NCT05734989 | Completed Results

• 1 other identifier: Pro00112455
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

In Aim 1 of 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. In Aim 2, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes. Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) and Black patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.

Conditions

Type 2 Diabetes; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Attended or Scheduled a Primary Care Physician (PCP) Visit

  up to 3 months after screening

• Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening

  Within three months of T0 (primary care appointment)

• Number of Participants Who Were Prescribed an SGLT2 Inhibitor (SGLT2i) and/or a GLP-1 Receptor Agonist (GLP-1 RA)

  Within three months of T0 (primary care appointment)

• Number of Participants Who Were Prescribed a Renin-Angiotensin-Aldosterone System Inhibitor (RAASi)

  Within three months of T0 (primary care appointment)

Study Arms (2)

Hispanic/Latinx patients at risk for CKD

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

Diagnostic Test: BP; Diagnostic Test: HbA1c

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.

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

Interventions

BP 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.

Hispanic/Latinx patients at risk for CKD

HbA1c DIAGNOSTIC_TEST

HbA1c will screen to identify patients with Type 2 diabetes

Hispanic/Latinx patients at risk for CKD

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

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

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

Eligibility Criteria

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

Study Population

Aim 1: Adults in the Durham, NC Hispanic/Latinx community at risk for hypertension and/or CKD

You may qualify if:

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

You may not qualify if:

• Unable to be reached by telephone

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; 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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Results Point of Contact

• Title: Matthew R. Sinclair, MD, MHS
• Organization: Duke University

matthew.sinclair@duke.edu

919-668-0113

Study Officials

• Matthew Sinclair, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: May 18, 2023
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)