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

Status: Enrolling

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

Treatments: Other: Cross-sectional Study Participants; Other: Focus Groups and Intervention Mapping; Other: Patient and Community Stakeholder Interviews

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05692388

PRO00043301

1K23MD016448-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

330 participants in 3 patient groups

Aim 1

Description:

Qualitative Aim

Treatment:

Other: Patient and Community Stakeholder Interviews

Aim 2

Description:

Quantitative Aim

Treatment:

Other: Cross-sectional Study Participants

Aim 3

Description:

Integrative Aim

Treatment:

Other: Focus Groups and Intervention Mapping