Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

April 27, 2026 updated by: Mukoso N. Ozieh, Medical College of Wisconsin
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social needs (HRSN).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Health-related social needs (HRSN) including loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.

Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews.

Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing HRSN.

Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mukoso N Ozieh, MD, MSCR
  • Phone Number: 414-955-8839
  • Email: mozieh@mcw.edu

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Mukoso N Ozieh, MD, MSCR
          • Phone Number: 4149558839
          • Email: mozieh@mcw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants will include African American adults with diagnosed diabetic kidney and reporting multiple social risk factors.

Description

Inclusion Criteria:

  1. self- report as AA/Black
  2. age ≥18
  3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
  4. self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD)
  5. able to communicate in English.

Exclusion Criteria:

  1. cognitive impairment at screening visit
  2. active psychosis
  3. active alcohol or drug abuse/dependency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aim 1
Qualitative Aim
Other: Patient and Community Stakeholder Interviews
Thirty in-depth face-to-face patient interviews, and ten in-depth structured stakeholder interviews will be conducted to explore and identify facilitators and barriers to self-care in African American adults with DKD experiencing HRSN.
Aim 2
Quantitative Aim
Other: Cross-sectional Study Participants
Three hundred African American adults with DKD experiencing HRSN will be recruited to participate in a cross-sectional study. All participants will complete a one-time survey, and blood samples and blood pressure readings will be obtained to assess clinical outcomes.
Aim 3
Integrative Aim
Other: Focus Groups and Intervention Mapping
A subsample of patient interview/cross-sectional study participants will be invited back to participate in four focus groups (five participants/group) to review components of the intervention, give feedback on appropriateness, feasibility, acceptability, and likelihood of having an impact based on their lived experiences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure (SBP)
Time Frame: Baseline
Blood pressure readings will be obtained using automated BP monitors
Baseline
Hemoglobin A1c (HbA1c)
Time Frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
Baseline
LDL cholesterol
Time Frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Baseline
Quality of Life (QOL)
Time Frame: Baseline
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. This 12-item scale is a valid and reliable instrument of functional status and provides a summary physical health-related quality of life (PCS) and mental health-related quality of life (MCS). Scores for each of the PCS and MCS range from 0 to 100, with higher scores indicating better physical and mental health-related quality of life, respectively.
Baseline
Self-Care Behavior
Time Frame: Baseline
Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale. This is an 11-item self-reported questionnaire including items assessing diet, exercise, blood glucose test, foot care, and smoking status. Higher scores indicate more engagement in self-care behaviors.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Mukoso N Ozieh, MD, MSCR, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00043301
  • 1K23MD016448-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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