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NCT05692388Recruiting

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

Medical College of Wisconsin

Start Date

1/23/2023

Completion Date

3/31/2027

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Patient and Community Stakeholder Interviews

OTHER

Cross-sectional Study Participants

OTHER

Focus Groups and Intervention Mapping

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Conditions

Diabetic Nephropathy Type 2 - UncontrolledDiabetes Mellitus, Type 2Chronic Kidney Diseases

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States