Clinical trial NCT05692388: Mixed-Methods Study of Multidimensional Adversity in Inner-City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Official title: Mixed-Methods Study of Multidimensional Adversity in Inner- City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Nephropathy Type 2 - Uncontrolled
Diabetes Mellitus, Type 2
Chronic Kidney Diseases
Keywords: Social risk factors
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-01-20
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will include African American adults with diagnosed diabetic kidney and reporting multiple social risk factors.

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 multidimensional adversity (MDA) and living in the inner-city.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: Baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: Baseline
measure: Quality of Life (QOL)
timeFrame: Baseline
measure: Self-Care Behavior
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mukoso N Ozieh, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References: