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Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease

NCT05357742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-26

No results posted yet for this study

Summary

The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.

The study objective will be achieved with the following aims:

Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.

Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.

Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.

Conditions

  • Diabetic Nephropathies
  • Diabetes Mellitus, Type 2
  • Chronic Kidney Diseases
  • Healthy Lifestyle

Interventions

BEHAVIORAL

Individualized basic need navigation and lifestyle coaching and skills training

During each session participants will receive the manualized study intervention which includes 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training.

BEHAVIORAL

Enhanced usual care

During each session participants will receive DKD education only.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357742 on ClinicalTrials.gov