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

NCT05692388 | Recruiting DMC

• 2 other identifiers: PRO000433011K23MD016448-01A1
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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

Diabetes Mellitus, Type 2; Diabetic Nephropathy Type 2 - Uncontrolled; Chronic Kidney Diseases

Keywords

Social risk factors

Outcome Measures

Primary Outcomes (5)

• Systolic blood pressure (SBP)

  Blood pressure readings will be obtained using automated BP monitors

  Baseline

• Hemoglobin A1c (HbA1c)

  Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.

  Baseline

• LDL cholesterol

  Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.

  Baseline

• Quality of Life (QOL)

  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

  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

Study Arms (3)

Aim 1

Qualitative Aim

Other: Patient and Community Stakeholder Interviews

Aim 2

Quantitative Aim

Other: Cross-sectional Study Participants

Aim 3

Integrative Aim

Other: Focus Groups and Intervention Mapping

Interventions

Patient and Community Stakeholder Interviews OTHER

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 1

Cross-sectional Study Participants OTHER

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 2

Focus Groups and Intervention Mapping OTHER

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.

Aim 3

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• cognitive impairment at screening visit
• active psychosis
• active alcohol or drug abuse/dependency

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Focus Groups

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)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mukoso N Ozieh, MD, MSCR

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mukoso N Ozieh, MD, MSCR

CONTACT

414-955-8839; mozieh@mcw.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: January 23, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-10

Locations

US (1)