Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05692388

Conditions

Diabetic Nephropathy Type 2 - Uncontrolled

Diabetes Mellitus, Type 2

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient and Community Stakeholder Interviews

Cross-sectional Study Participants

Focus Groups and Intervention Mapping

Study Details

Brief summary:

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).

Conditions

Diabetic Nephropathy Type 2 - Uncontrolled

Diabetes Mellitus, Type 2

Chronic Kidney Diseases

Study ID

NCT05692388

Start date

Jan 23, 2023

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Arms

Aim 1

Qualitative Aim

Aim 2

Quantitative Aim

Aim 3

Integrative Aim

Interventions

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.

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.

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.

Primary outcome measure

  • Systolic blood pressure (SBP) [ Time Frame: Baseline ]
  • Hemoglobin A1c (HbA1c) [ Time Frame: Baseline ]
  • LDL cholesterol [ Time Frame: Baseline ]
  • Quality of Life (QOL) [ Time Frame: Baseline ]
  • Self-Care Behavior [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Mukoso N Ozieh, MD, MSCR

414-955-8839mozieh@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Mukoso N Ozieh, MD, MSCR

4149558839mozieh@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 1, 2026

Last verified

Oct, 2025

Keywords

  • Social risk factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-01.