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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692388
• Other study ID #: PRO00043301
• Secondary ID: 1K23MD016448-01A
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Medical College of Wisconsin
• Contact: Mukoso N Ozieh, MD, MSCR
• Phone: 414-955-8839
• Email: mozieh[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

1. cognitive impairment at screening visit

2. active psychosis

3. active alcohol or drug abuse/dependency

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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 MDA and living in the inner-city.
• Cross-sectional Study Participants
Three hundred African American adults with DKD experiencing MDA and living in the inner-city 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.
• 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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

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