Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Cross-sectional Study Participants
- Conditions
- Diabetic Nephropathy Type 2 - Uncontrolled
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 330
- Locations
- 2
- Primary Endpoint
- Self-Care Behavior
- Status
- Recruiting
- Last Updated
- yesterday
Overview
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).
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.
Investigators
Mukoso N. Ozieh
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •self- report as AA/Black
- •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.
Exclusion Criteria
- •cognitive impairment at screening visit
- •active psychosis
- •active alcohol or drug abuse/dependency
Arms & Interventions
Aim 2
Quantitative Aim
Intervention: Cross-sectional Study Participants
Aim 1
Qualitative Aim
Intervention: Patient and Community Stakeholder Interviews
Aim 3
Integrative Aim
Intervention: Focus Groups and Intervention Mapping
Outcomes
Primary Outcomes
Self-Care Behavior
Time Frame: 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
Time Frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Systolic blood pressure (SBP)
Time Frame: Baseline
Blood pressure readings will be obtained using automated BP monitors
Quality of Life (QOL)
Time Frame: 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)
Time Frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.