Mixed-Methods Study of Multidimensional Adversity in Inner-City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Recruiting

• Conditions: Diabetic Nephropathy Type 2 - Uncontrolled; Diabetes Mellitus, Type 2; Chronic Kidney Diseases
• Interventions: Other: Cross-sectional Study Participants; Other: Focus Groups and Intervention Mapping; Other: Patient and Community Stakeholder Interviews

• Registration Number: NCT05692388
• Lead Sponsor: Medical College of Wisconsin

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 multidimensional adversity (MDA) and living in the inner-city.

Detailed Description

Multidimensional adversity (MDA), defined as having three or more social adversities such as 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 MDA and living in the inner-city.

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

Aim 2 (Quantitative): Examine the effect of increasing burden of MDA 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 MDA and living in the inner-city.

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 MDA and living in the inner-city.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-01-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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. diagnosed type 2 diabetes (T2DM) with HbA1c≥8 and chronic kidney disease (CKD) including ESRD
5. able to communicate in English.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aim 2	Cross-sectional Study Participants	Quantitative Aim
Aim 3	Focus Groups and Intervention Mapping	Integrative Aim
Aim 1	Patient and Community Stakeholder Interviews	Qualitative Aim

Primary Outcome Measures

Name	Time	Method
Self-Care Behavior	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.
LDL cholesterol	Baseline	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Systolic blood pressure (SBP)	Baseline	Blood pressure readings will be obtained using automated BP monitors
Quality of Life (QOL)	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.
Hemoglobin A1c (HbA1c)	Baseline	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States