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

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05734989
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
200
29.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: BP
  • Diagnostic Test: HbA1c
  • Behavioral: PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Improving Screening and Therapy Provision Among Hispanics/Latinx at Risk for Chronic Kidney Disease
Anticipated Study Start Date :
Feb 14, 2023
Anticipated Primary Completion Date :
Feb 13, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Hispanic/Latinx patients at risk for CKD

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

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.

Diagnostic Test: HbA1c
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Number of patients referred to PCPs (Primary Care Providers) for CKD screening [3 months from referral]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Matthew Sinclair, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05734989
Other Study ID Numbers:
  • Pro00112455
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023