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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase
Study Type: Observational
Observational Model: Other
Time Perspective: Cross-Sectional

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

Contact:
Mukoso N Ozieh, MD, MSCR
4149558839
mozieh@mcw.edu

More Details

NCT ID: NCT05692388
Status: Recruiting
Sponsor: Medical College of Wisconsin

Study Contact

Mukoso N Ozieh, MD, MSCR
414-955-8839
mozieh@mcw.edu

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.